Process evaluation of the CODES interventions

Introduction

Three nested qualitative studies were completed during the study to provide further valuable information regarding the subjective experiences of the patients and HCPs involved in the trial. The overarching aim of these three nested studies was to explore the views of (1) the patients involved in the CODES interventions, (2) the psychiatrists delivering SMC and (3) the therapists delivering the CBT intervention. We recognised that the experience of each of these three groups in the trial would differ and that we could not have an identical questioning approach (and, therefore, overarching theoretical framework) that could apply to each group; however, we aimed to reveal aspects of the different treatment arms that patients and clinicians found useful and to identify potential barriers to change. Given that each of these studies could yield complex data that could be described in detail separately, we further synthesised the results from these studies for the purpose of the current report. Thus, triangulation of the findings of each of these studies was undertaken to help clarify any practical implications of this research. We then undertook a predominantly quantitative survey of neurologists involved in the study and report this (and its methods) after the qualitative study (see Neurologists’ experiences of participating in the CODES trial). We have documented aspects of this work elsewhere.135,137,152,153

There is very little research exploring the experiences of HCPs working with patients with DSs. Existing quantitative research indicates that there is a gap in the knowledge among medical professionals who regularly encounter the condition.154 Many HCPs report having a poorer understanding of DSs than of epilepsy, with some considering the condition as untreatable or within the patient’s control.155–157 Negative experiences with patients are frequently reported157 and clinicians often describe a feeling of hopelessness.158 HCPs’ perceptions are likely to have an impact on how patients experience their condition, influencing how far they accept their diagnosis and comply with psychological interventions.

Owing to the complexity of the interventions tested in the CODES trial and, for some, the novelty of the care pathway that was introduced, a qualitative approach was used to capture patients’ and clinicians’ views more comprehensively. Using interview methods allowed patients and clinicians to elaborate on their responses, unconstrained by a questionnaire, and adopting a mixed-methods approach in a RCT has been shown to provide essential insight into how and why an intervention is effective.159,160 Given the large number of neurologists involved in the study, it was not feasible to undertake in-depth interviews with a sufficiently sized representative sample; therefore, we gathered, via an online survey, predominantly quantitative information on neurologists’ experiences of their involvement in the CODES care pathway.

Qualitative studies

Methods

Recruitment

Patient participants

Trial participants were asked at the end of the 12-month follow-up if they were amenable to participating in a qualitative study about their experiences in the trial and of having DSs. The sampling frame created for the study was based on ensuring that we interviewed those reflecting the larger study sample in terms of gender, location and age. We initially planned to interview 20 individuals who received CBT + SMC and 10 individuals who received SMC alone. Participants who were ambivalent about, resistant to or did not engage with treatment were also deliberately solicited to ensure that a range of responses was represented. We did not include any participants who refused follow-up. Interviews were undertaken by three researchers between February 2016 and April 2018; two participants refused to take part.

Psychiatrist participants

Of the 29 psychiatrists involved in the CODES trial, we used purposive sampling to select 10 psychiatrists, including people from a range of sites and reflecting their range of experience in treating functional neurological disorders (FNDs), particularly DSs. We excluded psychiatrists who were CODES trial grant holders from those interviewed to avoid bias from those involved in designing the trial. The selected psychiatrists worked at nine NHS trusts across England and worked in either liaison or neuropsychiatry specialties. Interviews were undertaken by one researcher between June and September 2017; there were no refusals to participate.

CBT therapist participants

Participants were recruited from the pool of 39 CBT therapists who treated patients in the CODES RCT. These therapists were situated across 18 NHS trusts throughout the UK and came from a range of professional backgrounds. The therapists provided a variety of outpatient services from the context of employment in hospital-based services and specialist community settings. Participants were selected to ensure a variety of both professional backgrounds and experiences of working with people with DSs, including within the trial. Sixteen potential participants were invited via e-mail to participate; of these, 12 clinicians from 10 NHS trusts participated. Interviews were conducted by one researcher between May and November 2017.

Interview procedure

From recognising the different experiences of the different participant groups within the trial, the interview schedules for each participant group were developed iteratively through discussion by members of the CODES research team.135,137,152 These members of the team, who were not involved in conducting the interviews, provided both clinical expertise, in terms of the topics covered, and methodological guidance. With respect to the patient participants, the topics were designed to explore their experience of receiving the diagnosis, the impact of DSs on their life, the experience of the study treatment(s) that they received and their thoughts about participating in the study. For the psychiatrists, topics were designed to focus on their experiences of delivering SMC within the CODES trial and their participation in the RCT more generally. Elsewhere, we have reported on the psychiatrists’ general experiences of working with patients with DSs.152 The interviews with the CBT therapists focused on their experiences of delivering the DS-specific CBT within the RCT and explored the value of certain aspects of the intervention. Furthermore, interviews explored the potential of effectively applying our manualised intervention to patients with DSs in the context of other difficulties. We also set out to understand whether or not the therapists felt that SMC sufficiently prepared their patients for therapy.

The semistructured interviews with the patients took between 45 and 90 minutes, whereas those with psychiatrists and CBT therapists lasted between 40 and 96 minutes. All of the interviews followed the relevant predetermined interview schedules (see Appendix 9). During the interviews, the participants were asked to illustrate their responses with examples where relevant. Probing techniques were employed by the interviewer to encourage the interviewees to expand on responses161 and to provide negative as well as positive reflections. Participants were interviewed face to face where possible; however, three CBT therapist interviews were held via teleconference owing to geographical distance and the impracticality of travelling to see the therapists in their place of work. In all other instances, the face-to-face interviews were undertaken at a time and a location to suit the interviewee.

Interviewers

None of the individuals conducting the interviewers was a qualified professional. The person interviewing the CBT therapists was a male, trainee clinical psychologist who was completing the interviews as part of the research component of their doctorate and who had experience in conducting in-depth interviews. Those interviewing the patients and psychiatrists were female research workers employed on the CODES project; one of the female researchers interviewed all of the psychiatrists and a subset of the patients. All were graduates and had experience of previous qualitative research. Although none was professionally qualified, all understood the condition being treated in the trial and, particularly in the context of the patient interviews, were able to be empathic with the interviewees. The person who was interviewing the therapists did not know these professionals prior to conducting the interviews. Those interviewing the patients and psychiatrists had prior working relationships with some but not all of the interviewees, which may have influenced the interviewees’ responses. All interviewers were able to reflect on the possibility that being a representative of the trial may have elicited positive responses about the trial and the intervention. However, adhering to the interview schedules and, as with the interviews of the therapists, encouraging negative as well as positive reflections were strategies employed to avoid bias and the eliciting of only positive reflections on aspects of the study. In addition, the fact that three individuals conducted the interviews with patients will have reduced any inadvertent bias from a specific interviewer.

All of the interviews were conducted, transcribed and coded before the main trial quantitative results were known; however, in the case of the patient interviews, the interviewer would have obtained information from the interview about that person’s outcome. Although all but one of the individuals conducting the interviews were involved in the coding process, other members of the research team contributed to the coding and interpretation of the results.

Analysis

Data analysis for the interviews with the patient participants and CBT therapists followed thematic framework analysis, which is deemed useful where groups of researchers work together.162 Thematic analysis163 was employed for the psychiatrists’ interviews. In all cases, the interviews were digitally recorded and transcribed verbatim by members of the CODES research team, resulting in anonymised transcripts that were then checked against the original recordings to verify their accuracy. NVivo 11 software (QSR International, Warrington, UK) was used to code all sets of data.

Thematic framework analysis began with familiarisation of the data by pairs of researchers (a lead researcher and another member of the team), for which the transcripts were read several times to establish initial ideas for recurring themes, in line with the a priori aims of each study. Researchers then allocated labels to sections of the text to indicate their understanding of the content. Meetings between members of the research team were held for each set of data (patients and therapists) and indicated considerable agreement in how material was coded as well as the definition of themes that arose from how the codes had been grouped into categories. In each case, the grouping of ideas into common categories or themes was used to create a theoretical framework. This framework was then applied back to the transcripts to establish whether or not the framework applied suitably to the raw data, referred to as indexing. Data were then charted to visualise the main themes and consider any interactions between them.

For the thematic analysis that was used to analyse the psychiatrists’ interviews, two researchers initially coded three randomly selected transcripts and initial codes and themes were discussed by the research team. All 10 transcripts were then coded independently by the two researchers, recording the coding in NVivo 11. The researchers identified themes to represent the interview content, with new themes added as subsequent interviews were analysed. Agreements with the coding and the establishment of the parameters of major themes were arrived at by holding regular meetings. Where both researchers identified the same overarching themes, they were then combined; subthemes were then organised under the relevant overarching theme.

For both types of analyses (thematic framework analysis and thematic analysis) the researchers coding the data used a deductive approach, despite that those undertaking the thematic analysis of the psychiatrists’ interviews did not chart the data. We then undertook a triangulation approach using the different data sources (i.e. data from the different sets of interviews) to identify common themes that emerged from the three sets of interviews. This approach is one of the four types of triangulation previously identified.164,165

Two members of the research team who were initially familiar with at least one set of transcripts and their resulting themes then undertook an iterative process of discussions and reduction and analysis of data from the three sets of interviews (patients, psychiatrists and CBT therapists). This was undertaken with the aim of looking for areas of agreement and divergence of opinion between the different groups. Further team discussions were held to further conceptualise the arising themes and supporting quotations were selected for each group of participants when documenting the themes; those undertaking the selection of quotations were mindful of selecting negative as well as positive quotations and to avoid presenting a biased summary of the findings.

Results

Participants

Patient participants

Twenty-two participants who had received CBT + SMC and eight who had received SMC alone were interviewed. Of the total sample, 21 (70%) participants were women and nine (30%) were men. Only two participants were not white British in terms of ethnicity. At the time of the interview, 10 (33.3%) participants were aged between 18 and 30 years, six (20%) were aged between 31 and 40 years, seven (23.3%) were aged between 41 and 50 years, two (6.7%) were aged between 51 and 60 years, four (13.3%) were aged between 61 and 70 years and one (3.3%) was aged between 71 and 80 years. Eleven participants were in full- or part-time employment or study. The range of time since onset of DSs (as reported by participants) was considerable, with five participants (16.7%) having experienced DSs for < 1 year, 15 (50%) having experienced DSs for between 1 and 9 years, six (20%) having experienced DSs for between 10 and 19 years, two (6.7%) having experienced DSs for between 20 and 29 years and one (3.3%) having experienced DSs for either 30–39 years or 40–44 years.

Of the people interviewed who had been allocated to receive CBT, 14 (63.6%) had attended all 12 sessions plus the booster session, one (4.5%) had attended 12 sessions, three (13.6%) had attended 11 sessions, one (4.5%) had attended 10 sessions and one (4.5%) had attended nine sessions. Thus, 20 out of 22 (91%) participants were compliant with CBT, having attended at least nine sessions.92 Of those participants not meeting this definition of compliance, one had received five CBT sessions and the remaining person had received only one session. Interviewed patients who were allocated to the SMC-alone arm had attended a median of four SMC sessions (range 2–6 sessions). More specifically, of those allocated to the SMC-alone arm, four had attended four sessions, three had attended three sessions and one had attended just one session. The patients allocated to the CBT + SMC arm attended a median of 3.5 SMC sessions (range 0–10 sessions), that is they attended a wider range of SMC sessions. Thus, four patients attended four SMC sessions, three patients each attended one, two, three and five sessions, two patients attended six sessions and one patient each attended nine and 10 sessions. Two patients attended no SMC sessions. None of the patients interviewed here reported any previous knowledge about DSs at the time of their diagnosis by a CODES neurologist. Of the currently interviewed sample, one person had concurrent controlled epilepsy. For eight people there was a record of epilepsy having been previously misdiagnosed. A further individual reported feeling that their seizures could be a mixture of DSs and epilepsy, although clinical opinion was that the diagnosis was DSs only.

Psychiatrists

Ten psychiatrists were interviewed: five women and five men. Of the total sample, six were working in liaison psychiatry, one in neuropsychiatry and three people had dual accreditation in both liaison psychiatry and neuropsychiatry. The psychiatrists’ ages ranged between 31 and 60 years, with 8 out of the 10 aged 41–50 years. Six psychiatrists worked in London and the remainder worked elsewhere in England. The group had between 11 and 28 years of clinical experience since their General Medical Council registration, with five psychiatrists (50%) reporting between 11 and 15 years of experience, two (20%) reporting between 16 and 20 years of experience, one (10%) reporting between 21 and 25 years of experience and two (20%) reporting experience falling within the range of 26–30 years. All reported experience working with patients with DSs and medically unexplained symptoms.

CBT therapists

Twelve interviews were conducted with therapists delivering CBT. The majority of these therapists (n = 10, 83.3%) were female. Five therapists were aged between 31 and 40 years, while the remainder were aged between 41 and 50 years. The majority (n = 9, 75%) reported that they had previous experience of working with patients with DSs, whereas 10 (83.3%) said that they had previous experience of working with patients with medically unexplained symptoms. Six individuals reported having spent between 0 and 5 years practising as a CBT therapist, two people had practised for between 6 and 10 years, two people had practised for between 11 and 15 years and two people had practised for between 16 and 20 years. The therapists’ professional backgrounds were self-reported as follows: clinical psychologist (n = 4, 33.3%), counselling psychologist (n = 2, 16.7%), psychotherapist (n = 2, 16.7%), CBT therapist (n = 1, 8.3%), neurological physiotherapist (n = 1, 8.3%), nursing (n = 1, 8.3%) and occupational therapist (n = 1, 8.3%). In terms of prior CBT qualifications, seven (58.3%) had no specific CBT qualification, two (16.7%) indicated that they had a diploma in CBT, two (16.7%) reported having a Master of Science in CBT and one (8.3%) had a Bachelor of Science in CBT. Six therapists were accredited with the British Association for Behavioural and Cognitive Psychotherapies. Four (33.3%) of the therapists worked in Greater London, three (25%) worked in north-east England, two (16.7%) worked in south-east England, two (16.7%) worked in south-east Scotland and one (8.3%) worked in the Midlands. At the time of the interview, the median number of trial patients treated by each therapist was 8.5 patients (IQR 3.25–12.75 patients).

Findings from the three participant groups

The overview of the themes from the different sets of interviews led to the classification of findings according to the following main themes: experience of receiving and delivering the diagnosis; CODES dissociative seizures factsheets; CBT engagement and delivery; and delivery, content and quality of SMC. Within these themes, we identified subthemes where relevant (Table 24). We have expanded on some of these findings elsewhere135,137,152 and noted that within the psychiatrist interviews in particular there was a consistent degree of agreement between respondents on the majority of topics. In the themes in the following sections we have reflected where divergent beliefs emerged.

Experience of receiving and delivering the diagnosis

Receiving the initial diagnosis

For our 30 trial participants, there was a very variable length of time prior to receiving the DS diagnosis. For many participants, this period was characterised by frequent trips to A&E departments and hospitalisations during which they reported that they had sometimes received traumatic and unnecessary medical interventions, AEDs and, not uncommonly, a misdiagnosis of epilepsy.

Prior to being assessed by a CODES neurologist, the generalised lack of knowledge surrounding DSs among HCPs, combined with a potential misdiagnosis or uncertain diagnosis, often left patient participants feeling bewildered and desperate for clear information and guidance. Against this backdrop, we found that the CODES trial participants interviewed here reported that the delivery of the diagnosis of DSs by CODES neurologists was the first time that they had ever heard of this diagnosis.

Participants recalled a range of emotions on receiving the diagnosis from relief (that they had a diagnosis and/or that it was not epilepsy) to disbelief (that it was psychological), as well as anger and frustration at there being no simple cure. A minority described feeling abandoned or cut adrift, sensing that the neurologists could not help them any further. Understanding the diagnosis and its implications took time. One participant who had been unable to accept the diagnosis from a neurologist (outside the trial) found that, having been referred to a CODES neurologist, their explanation of DSs finally made sense:

I think because she’d [neurologist] seen part of one [a seizure] and she explained it in the way that we would talk. And she just really explained how it actually happens and how they work. And for the first time I thought that’s me . . . and it all started to fall into place, make sense. ‘Cos it had been so long not knowing what was going on and thinking I was having every kind of whatever . . . and then to understand. It was fantastic.

Approaches to and perceptions of diagnosis delivery

The complexity of both delivering and receiving the DS diagnosis continues to be an area of ongoing concern.166 Given the absence of clear, uniform care pathways across the UK for people with DSs, CODES psychiatrists reported that, by the time they reach psychiatric services, patients are often sceptical of or struggling with the diagnosis. When explaining the DS diagnosis, most of the psychiatrists felt that the explanation should be specific to the individual patient so that it was meaningful to them. A way of doing this was to relate the explanation of the diagnosis to the patient’s personal life experience. This link to a personal life event could assist patients who struggled with emotional literacy to understand dissociation and the DS diagnosis.

The majority of the psychiatrists commented on the need for caution when explaining the diagnosis to the patient. This meant being careful with their choice of words and taking cues from the patient themselves as to what was likely to upset or cause offence:

. . . for other people anxiety can be a problem. I’m careful about using that word if they have been very clear with me they don’t think they are anxious.

It was also important not to draw conclusions too quickly as to how the DSs had developed. From a clinical perspective, psychiatrists felt that it was important to move at the patient’s own pace in developing their understanding of the condition.

The CODES psychiatrists noted that the patients who were referred to them in the study were, overall, more accepting than those outside the trial of their DS diagnosis. The psychiatrists seemed to attribute this to patients having received a more detailed delivery and explanation of the diagnosis from neurologists. This may have been influenced by better resources being available to neurologists, such as the CODES Dissociative Seizure Factsheet (Neurology), as well as guidelines for delivering the diagnosis and a clear care pathway:

I did notice as well that everybody coming to see me was much more OK about their diagnosis than was previously the case . . . previously I used to get a lot more people who were unhappy with the diagnosis.

Nevertheless, therapists felt that the complexity of the diagnosis remained a challenge, and some patients appeared to remain unclear about their diagnosis and treatment. Where there was poor diagnostic understanding, however, therapists did not necessarily feel that this was because of a lack of effort by neurologists and psychiatrists to explain the condition. Therapist interviewees noted the complicated nature of a DS diagnosis and the difficulty involved in relating such a difficult concept in a comprehensible way in a short time:

. . . so I don’t think it’s that they didn’t hear it. I think they heard it and they tried their best, to try and get that over, but it’s such a hard concept – ‘so what I just collapse?’, ‘how does that happen?’, you know ‘my brain just shuts down? how does that happen?’.

CODES dissociative seizure factsheets

Improving understanding

According to many trial participants, aside from the explanation of DSs by the neurologist, it was the CODES factsheet given to them at that initial appointment that often marked a turning point in their improved understanding of DSs. Participants reported that the booklet not only offered hope that there were HCPs in CODES who understood but who could also potentially help them.

One participant recalled her reaction to reading the CODES Dissociative Seizure Factsheet (Neurology):

It was like a reassurance. So this is what’s happening and that’s OK. When I got those that’s when I gave them to my parents. I copied them and gave them to my parents and said this is what’s wrong with me and they were really good about it actually. It sort of made sense to them.

Thus another benefit was that they could refer to the factsheets subsequently when trying to explain DSs to others. Patient participants often expressed how hard DSs had been to describe to both family and friends, and said that they had given the booklets to others, including the GP, as they found the condition so hard to explain themselves. Two out of the 30 patients interviewed admitted not really reading the factsheets: one because she found it hard to read anything in book form and the other because he did not want to.

CBT therapists placed great value on the factsheets, and the majority said the fact that participants received a prescribed explanation of their diagnosis from neurologists and psychiatrists, as well as receiving educational materials, meant that those participants randomised to CBT seemed to attend therapy with more diagnostic understanding than those seen outside the RCT.

Useful professional resource

Analysis from the interviews of psychiatrists showed broad consensus that the dissociative seizures factsheets given to participants were very beneficial. Psychiatrists seemed to enjoy reading the Dissociative Seizures Factsheet (Psychiatry) themselves and found this factsheet a useful reference point for medical trainees and their own work. There was a general agreement that having something prepared and in colour to give to patients during or at the end of an appointment was valuable, as the patient and others could refer to the materials outside the clinic. They also felt that the anxiety and avoidance commonly found in this patient group may mean that they struggle to take in everything that is being said during a consultation, so the booklets could increase the amount of good-quality information to which they can refer.

Cognitive–behavioural therapy engagement and delivery

Helpful cognitive–behavioural therapy techniques

The majority of the CBT therapists reported that they found the seizure control techniques recommended in the therapy manual to be helpful in working with their trial patients. From the therapists’ point of view, it seemed that trial patients initially felt that they had no control over their seizures. Therapists introduced participants to a range of CBT techniques to help with seizure management, including (but not exclusively) progressive muscle relaxation, breathing, distraction and refocusing, visualisation and graded exposure:

It can give them a sense of control and obviously it could make a difference if, if they know that they are not going to have it in an embarrassing situation, that if they know, say if they are going out to, I don’t know a wedding.

As these techniques were introduced, a number of those randomised to CBT were able to use them to potentially delay a seizure or even stop one completely. The clear majority of the 22 CBT participants said that they had found a CBT technique that was effective and which they were still practising long after therapy had ended. Eighteen of the 22 CBT participants found that controlling and slowing down their breath by breathing from the stomach helped them to relax and even to divert a seizure. One of the 18 participants found that breathing through stomach pain (a warning sign of a seizure) helped her in seizure management. However, two of the CBT participants said that the breathing technique made them feel dizzy and that they could not progress with it. Distraction techniques, such as tuning into sound or tapping or counting down from 100 to 1, were also named as effective at managing seizures. Utilising breathing techniques had really helped one SMC participant after they had found these on a website. Participants seemed to understand that the techniques were there to be tried and tested, and if they did not like a technique or it did not work it was worth trying another one.

In line with the fear–avoidance model of DSs used in the current trial, the identification of avoidance behaviours and the use of graded exposure to address them were key tools of the intervention. Therapists deemed graded exposure to be useful depending on the presence and nature of avoidance, finding behavioural avoidance more easily addressable within the therapy than emotional avoidance:

Once they started to do some behavioural stuff and, and and if they . . . went out and did something and found that their anxiety went down, that was a ‘light-bulb moment’ for some people.

This view was supported by several participants who received CBT and who reported that although initially very anxious and thereby avoidant of travelling to the therapy sessions alone on public transport, they were progressively able to use travelling to therapy as a goal set as part of their homework. To consolidate what they were learning in therapy, several CBT participants reflected that homework had been an essential part of their progress and that they had understood the rationale underpinning it:

Oh it [homework] definitely helps. The key to having successful CBT is repetition cos once you’ve had that repetition – it’s a bit like practice makes perfect – cos once you’ve had that repetition it’s programmed in your muscle memory and you can recall these techniques or just go back to thinking what you’ve learnt in those sessions.

One of the CBT participants, however, found homework too emotionally challenging:

I didn’t like any of it. Well, some of it was OK but the writing down the thoughts and feelings and all that I hate. I’m not good at that because that just brings everything back and it just makes me feel worse. We got round that by doing other things.

A number of CBT therapists also recalled that homework was too challenging for some participants because of high levels of avoidance among those who did not want to take the ‘work’ outside the sessions. Equally, there were those participants at the opposite end of the spectrum who did not appear to be avoiding anything and so setting avoidance-orientated homework goals proved challenging for therapists.

CBT therapists felt that the participant handbooks (i.e. the ‘Manual for Patients Attending CBT’ containing chapters supplementing the content of the CBT sessions) were helpful. They recalled participants’ positive feedback about certain sections, particularly those on trauma and distraction/refocusing. Therapists found it helpful to be able to refer to these handbooks in sessions to help explain homework. Of the trial participants, five mentioned that they remembered receiving other handouts from the CBT therapists to help with homework techniques between sessions, but referred to them and the handbook in general terms only rather than describing specific sections. For one participant, they were a mitigating factor against an impaired memory:

There was quite a few worksheets and bits that she did which were really helpful because then I could take them away. My problem is that I have such a bad memory that if I just have a talking therapy I can’t always remember what she said to do or to work on. And a week gets so busy in my life with having children and everything else that I often forgot, so by having something visual I could refer back to it and that was really good.

Family presence – help or hindrance?

The role of family members and partners, both at the point of diagnosis and later in therapy sessions, emerged as a key factor in CBT therapists’ interviews but to a much lesser degree in those of the trial participants. A few participants felt that it was vital to have someone else there when seeing neurologists or other doctors because they reflected that they would have felt unable to process all of the information in these consultations, citing poor memory, high emotion or anxiety.

Involving family members in the recovery process was prescribed in the therapists’ manual. Participants were asked to bring a family member or partner to session 3 to explore whether or not there were factors in their lives that may be perpetuating their problems.

Seven CODES therapists expressed their approval of incorporating family members within the therapy protocol. There was broad consensus among them that family members can play a marked role in helping relatives to recover from DSs. Interviewees commented that participants’ families had often experienced DSs to be distressing episodes and that their potentially overprotective responses may be counterproductive to recovery. Therapists believed that providing the family with a rationale of the treatment and introducing the family to a more ‘hands-off’ approach early on was helpful:

So I think that culturally, generally, you know, they are of a culture where family gets very involved and helps out and jump in and do things for each other in general, and whoever is the sick one in the family, you know they will help out. But on the positive side, I think that they were actually quite ready and maybe, you know, happy to, you know use the information to take a little bit of a step back.

However, 3 of the 12 therapists observed that this new approach to managing DSs, by changing habits that may be quite entrenched, could be difficult for family members to adjust to. Almost half of the therapists, however, found that the chapter for family members in the patient handbook was a helpful tool in supporting them to understand the recommended approach to DSs.

Only five of the patient interviewees who had received CBT talked about family members attending therapy and, although generally positive, there were some mixed feelings about it. Although initially welcoming the idea of bringing in his wife, one participant said that he did not feel that her presence was ultimately helpful to him because he had started to censor what he said in the sessions. However, for the remaining four participants, the involvement of parents, carers and other family members had been positive. For them, the sessions with a family member were times when difficult conversations could take place, with the therapist acting almost as family mediator or at least providing a safe, neutral space. For one participant, inviting a mother and later on a carer into the session was the opportunity to explore ways of relaxing the overprotective ‘rules’ that had been deemed to keep the participant ‘safe’ and to allow them to perform small chores as recovery progressed:

But then [CODES CBT therapist] as well invited Mum because some of the things he asked me to do freaked my Mum out like using a kettle. I mean I’d dropped a bottle of wine before and she was really worried but [CODES CBT therapist] reassured her and when she saw my progress and stuff, she was encouraging me. Obviously she was still concerned.

Concerns and dislikes concerning therapy

A number of psychiatrists thought that participants may be deterred by difficult issues that could emerge in CBT or the SMC sessions. They cited a range of reasons that might deter participants from the challenges of CBT, such as emotional illiteracy, avoidance, ambivalence towards the DS diagnosis or being unable to identify a reason for the onset of DSs.

Conversely, a few psychiatrists felt that simply signing up to the CODES trial meant that participants had a certain desire to engage with a psychological understanding of DSs and in that sense were a self-selecting group. One psychiatrist also felt that the clarity of the study protocol was a way of engaging participants in therapy.

As for the patient participants, when asked about their pre-randomisation treatment preference, many of the participants in the CBT arm said that when they were first told that they had been randomised to therapy they had initially reacted with fear, thinking that sessions would involve ‘sitting around in groups’ or being forced to relive painful childhood experiences. Many of the CBT participants reflected afterwards that these fears had proved unfounded. Two of the SMC participants recalled being glad that they were not assigned to CBT because they felt that they would never have been able to talk at length to someone on a weekly basis.

For patient participants who did not attend all 13 sessions (i.e. 12 sessions plus the booster session) or who disengaged from CBT, there were specific issues such as not liking the CBT techniques or finding the behavioural experiments extremely challenging. One person who disengaged after session 9 felt that CBT techniques, such as breathing, were meaningless, as he had no warnings of a seizure so there was no point in trying to control them. He was also frustrated by the session being limited to 1 hour:

It’s never long enough and it’s never in-depth enough. As I said she had a schedule to work with and it really did, not sort of upset me but it was always, there was so much more I wanted to say or do but couldn’t because she’d say right your hour’s up . . .

Another CBT participant who stopped attending after session 10 felt that she was not learning anything new from the CODES CBT, as she had previously received CBT for depression. A second CBT participant, who had been frequently housebound and had high levels of social anxiety, was adamant that CBT had helped in terms of seizure reduction and her approach to DSs. She had, however, attended only five sessions owing to serious family illness. Separately, however, she recalled her fear of undertaking behavioural experiments, such as walking around in public with the therapist at her side:

And we walked from the hospital to the town and that was just, yeah, mental. I actually feel like I could have strangled her [the therapist] . . . You’re not just frightened of the seizure but what other people are going to do. Are they going to hurt you, are they going to kick you? . . . And are cars going to run you over and are people going to look at you?

Challenges to delivering and receiving therapy

For the CBT therapists, having managed to engage participants in therapy, there was an enormous range of complexities and comorbidities that complicated a structured therapy and even occasionally derailed it. Among the reasons cited by therapists were housing or family issues; self-harm; suicidal tendencies; physical health problems, such as comorbid controlled epilepsy; or an ongoing major depression that needed to be tackled with goal-setting (e.g. ‘getting dressed each day’) before starting any graded exposure for the seizures. Therapists generally felt that the structure of the manualised therapy allowed them to get things ‘back on track’ from the aforementioned obstacles. However, once engaged, therapists sometimes found that convincing participants to desist from using behavioural coping strategies that were keeping them ‘safe’ could be challenging for patients.

Given the complex presentations seen in the patients, three therapists indicated that it might be important that an intervention, such as that employed here, warranted the involvement of suitably qualified and experienced clinicians:

But again we come back to therapist skill. That, yeh, I do think you’re working with very complex people . . . I don’t think being a kind of newly qualified CBT therapist would manage it.

From the patients’ perspective, problems surrounding transport were the predominant barrier to attending appointments. Given the high levels of dependent living and the distance initially reported by patient participants, making long journeys to hospital appointments often meant relying on the availability (and goodwill) of family, friends, hospital transport or a combination of these. Twenty out of the 30 patient participants mentioned that transport was a barrier to attending appointments; only five out of the 20 participants had been able to travel on public transport on their own. These concerns were incorporated into the treatment by some therapists. Fear of travelling alone could be used to devise a CBT homework goal and three of the CBT participants found that the confidence that they gained from therapy enabled them to start travelling to sessions independently.

The CODES psychiatrists also felt that the lack of local service provision for people with DSs meant that being faced with long distances to attend SMC appointments was a definite deterrent; the trial did not reimburse travel costs to these appointments. They were aware that when the study stopped in some centres there would be no local provision for patients with DSs, which presents a significant challenge to a group of patients who can often be quite disabled. However, the psychiatrists also cited other practical issues for patients, such as work commitments, child care, hospital parking and other comorbidities.

Although noting that travel was an issue, the therapists more readily identified other concerns as being related to dropout, such as disagreement with the diagnosis.

Delivery, content and quality of standardised medical care

Owing to the pragmatic nature of the study, the study protocol anticipated (rather than prescribed) three to four psychiatry follow-up sessions.84 From the psychiatrists’ perspective, offering SMC appointments with participants could prove challenging, mainly because of service pressures, policies and variations in structure. Pressures on resources meant that some sites would not usually offer more than a set maximum number of follow-up appointments; others would not necessarily follow-up patients with DSs at all, unless they had clear psychiatric comorbidities. Other services struggled or were unable to offer more than one follow-up appointment over the year following randomisation.

Providing standardised medical care

Many psychiatrists felt that the CODES approach to SMC was very similar to what they were doing in their daily practice with this group of patients anyway. However, some changes to practice were required. Psychiatrists were asked in the CODES SMC guidance document to omit the use of CBT techniques; however, they could give basic advice on breathing and distraction methods. This was felt to be slightly restrictive, especially if the psychiatrist had CBT training or CBT formed a core part of their usual practice:

We did diaries, we did quite a lot of um behavioural and cognitive advice . . . also sort of stress management techniques or distraction techniques, grounding and all that, so we used to do that in our clinic [describing usual SMC practice outside CODES].

In terms of longer-term roll-out, psychiatrists indicated the challenge of creating a care package that could be widely implemented with homogeneity in terms of the content and quality of SMC provided. As well as this, some psychiatrists felt that SMC could not be sufficiently standardised owing to the variable levels of experience among clinicians working with the disorder:

There’s no standard across different hospitals or different services or different centres . . . or in fact probably there was not any standard medical care between clinicians to clinicians, different people at different levels depending on their exposure to the condition.

Related to this was the perceived lack of education and training both for psychiatrists and for other healthcare providers with respect to working with patients with DSs or FND more generally, and the harm that this could do:

I’ve found people have found it very upsetting . . . find it more difficult to accept the diagnosis if they kind of been shunted around different services and people are like ‘Oh what’s this I’ve never heard of it’.

Benefits of the multidisciplinary care pathway

All but one of the 12 CBT therapists provided positive feedback on aspects of SMC. Several indicated that their patients had reported positive interactions with psychiatrists or neurologists and that their concerns had been listened to. Six therapists acknowledged the value of the close working relationships that they had experienced with their neurology and psychiatry colleagues within CODES. They felt that study patients had benefited from their own cohesive working with neurologists and psychiatrists and that this had helped diminish any sense that patients may have had of being ‘abandoned’ by these professionals following their allocation to CBT. Six therapists said that they felt that the quality of medical care delivered to trial participants was more favourable than that which they might have otherwise received. In some cases, therapists indicated that for patients not in such a trial there might be accounts of far less positive experiences of medical care prior to therapy, and that this could hamper engagement in therapy. Therapists described aspects of the SMC used in CODES that had appeared to facilitate this process, including, as indicated above, the CODES factsheets given to patients by neurologists and psychiatrists and the standardisation of the explanation given to participants.

Therapeutic relationships

Patients’ views of SMC were, overall, positive and many people welcomed an additional level of help and care, understanding that these sessions would comprise a general review of their DSs or therapy or a chance to talk about medication. For two participants who had received CBT and one in the SMC-alone arm, the relationship with the psychiatrist had been vital to their recovery. For the two receiving CBT, therapy had led to the disclosure of trauma that, in turn, had almost derailed therapy. At these points, having a psychiatrist who they could trust as well as a therapist had allowed them to feel that there was an integrated team looking after them; they both reported that this had been invaluable. For the participant in SMC alone, the psychiatrist was the person who, he felt, had really confirmed the neurologist’s diagnosis of DSs and he felt able to confide in him:

It’s completely different speaking to someone that you know than to speaking to a stranger. With a stranger you can be your true self even if it was the angry, closed-off person that was me.

One SMC-alone female participant said that she felt unsupported by both the neurologist and the psychiatrist in her coming to terms with a DS diagnosis, after being originally misdiagnosed with epilepsy and having taken AEDs for years. She was one of two out of the eight participants in the SMC-alone arm for whom the relationship with the psychiatrist appeared to be overshadowed by a previous diagnosis of epilepsy, leaving both participants resistant to the idea that DSs was a psychological disorder. In contrast to the majority of the participants, they both resisted any suggestion that the seizures could be possibly connected to difficult life events and viewed SMC appointments as a waste of time:

I’m not a down person 24/7 so I don’t need to be speaking about, you know he couldn’t like see no problems or, there’s nothing that could be pinpointed, I said to him time and time again I’ve spoken to everybody I can think of and there’s no reasons why people can think of me having them.

In addition, several of the participants felt that the length of time between the SMC appointments was disappointing.

Progress during standardised medical care

The psychiatrists reported that some patients improved with SMC appointments and without CBT or other therapy. Some of the varying examples of positive progress included persuading a participant to start an antidepressant when there was a significant anxiety disorder present, leading to an improvement in mental state and subsequent reduction in seizures, as well as reducing focus on symptoms and A&E attendance:

Because of there was obviously something; some containment going on there . . . there has actually been an improvement.

Psychiatrists were at times surprised by the progress made by seemingly very complex patients; factors contributing to this could be a good working alliance and an effective holistic assessment of the patient and their strengths.

The psychiatrists differed to some extent in terms of who they felt benefited from SMC and particularly whether or not those who benefited from SMC had to be more or less psychologically minded; several clinicians said that they felt that high-risk patients with distinct psychiatric comorbidity may be better suited to SMC than CBT:

Where there is a clearly defined anxiety disorder or depressive disorder which you think you can treat effectively with medication, they’re quite good to be seen in SMC.

Summary

The CODES psychiatrists and CBT therapists felt that the patients who were referred to them in the study on the whole had a better understanding of the DS diagnosis than patients who might normally be seen outside the trial, owing to the more detailed delivery and explanation of the diagnosis from neurologists; this suggested that this early stage in the care pathway was important to the subsequent engagement of patients. There was consensus among trial participants, CBT therapists and psychiatrists that the dissociative seizures factsheets helped in understanding the diagnosis and were a valuable resource, providing clear information that could be understood by family and friends and other HCPs. Many of the participants randomised to CBT reflected very positively on their experience of treatment and felt that they had developed useful CBT skills to help with seizure management; however, treatment was not without its challenges for both the participants and the therapists and not all techniques were equally well experienced or implemented in all cases, highlighting the need to have a range of strategies to offer to patients. SMC was also positively received by most patients, and the psychiatrists noted that it could by itself lead to improvement. For the psychiatrists, keeping CBT techniques out of SMC appointments could be difficult, especially because all the psychiatrists interviewed had some therapy training.

Limitations

We acknowledge limitations to our qualitative evaluations. We interviewed only 10 psychiatrists and 12 therapists; psychiatrists working in Scotland and Wales were not interviewed and we did not interview therapists from all participating centres, meaning that some service-related biases may have been present. All healthcare provider participants were involved in the CODES trial and knew either the interviewer or other members of the project team; although it is possible that this may have influenced their responses, as the interviews did not exclusively ask about the CODES trial, other responses may have been less likely to be affected by these professional relationships. Patient participants were, as intended, mostly chosen to enable reflections to be gathered on CBT; however, we may not have adequately sampled those failing to complete treatment and we cannot be certain that we would not have elicited further themes had we interviewed more patients in the SMC-alone arm.

Neurologists’ experiences of participating in the CODES trial

Introduction

Within the CODES trial, neurologists were required to assume an important role in the treatment pathway. The aim of this process study was to explore neurologists’ experiences of their often more-than-usual in-depth role within the treatment of DSs and their thoughts on working with patients recruited to the CODES trial. More specifically, we investigated neurologists’ knowledge of DSs and their clinical practice for the condition before and after their involvement in the trial, as well as their opinions about CODES-related components. As we could not undertake a representative sample of qualitative interviews because 91 neurologists/epilepsy specialists had participated in the study, clinicians were asked to complete an online survey comprising 43 questions yielding qualitative and quantitative data.

Methods

Recruitment

We invited 84 neurologists/epilepsy specialists via e-mail to participate in this process evaluation (all 91 participating CODES neurologists/epilepsy specialists were e-mailed initially, but the e-mail addresses of seven were no longer active). We employed the Bristol Online Survey Tool to distribute a specially designed 43-item questionnaire, with all items outlined elsewhere.153 Clinicians were sent a reminder to complete the survey 2 weeks after the initial invitation. All data were provided anonymously.

Questionnaire

The survey was developed by members of the CODES team. The questions covered the following: (1) demographics (six items) – gender, age, clinical role, years of experience in clinical neurology and number of patients with DSs diagnosed per month and under their care; (2) knowledge about DSs and interventions prior to and after their participation in the CODES trial (four items); (3) clinical practice before, during and since participation in the CODES trial (22 items); and (4) their views about CODES-related components (11 items).

We included predominantly quantitative (Likert) scales with multiple options (1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree and 5 = strongly agree), as well as open-ended questions.

Data analysis

Descriptive statistics were reported for quantitative data. Data comparing self-report scores before and after CODES participation were analysed using the Wilcoxon signed-rank test. Statistical significance was assessed at a p-value < 0.05. Data were analysed using SPSS 24 (Statistical Product and Service Solutions Inc., IBM Corporation, Armonk, NY, USA). Qualitative data from open-ended questions were grouped thematically; further specific quotations are presented elsewhere.153

Results

Respondents’ demographics

Forty-three (51%) out of the 84 contacted neurologists completed the survey. Most were consultant neurologists (n = 40); the remaining three were one specialty registrar, one staff grade and one GP with a special interest in neurology. Most of the clinicians were male (60.5%) and aged 41–60 years (81.4%). The median number of years of clinical experience in neurology was 18 years (IQR 13–22 years). Respondents indicated that the median number of patients who they would typically diagnose with DSs per month was three (IQR 2–5 patients), and the median number of patients with DSs under their care at any one time was 20 (IQR 9.5–50.0 patients).

Knowledge about dissociative seizures

Neurologists generally reported a good level of knowledge about DSs before their involvement in the CODES trial (median 4, IQR 4.0–5.0). This did not change as a result of their participation in the trial (median 5, IQR 4.0–5.0; p = 0.76). Similarly, doctors self-reported a good level of knowledge of the therapeutic potential of psychological interventions for DSs before (median 4, IQR 4.0–5.0) and after their involvement in the trial (median 4, IQR 4.0–5.0; p = 0.67).

Participants’ clinical practice when working with patients with dissociative seizures

Thirty per cent of the neurologists reported that participating in the CODES trial had changed their practice regarding referring participants to psychological interventions. This included making earlier and more direct referrals for DSs, and the development of a DS pathway within their organisation as a consequence of the study. Of those who had not changed their practice, some already had local and well-developed specialised psychotherapy services in place for DSs. Others were still unable to refer to psychotherapy for DSs following the trial. During the trial, there was an improved ability to refer patients who lived outside the practice area to psychological services.

Around half (53.5%) of the respondents reported being able to refer patients to DS-specific psychological intervention before the CODES trial. This figure did not change after the conclusion of the trial. The availability of services appeared an important determinant. Doctors who had access to DS-specific psychological intervention prior to the trial referred around 78% of patients to these services. The comparable estimate from those who could not directly refer patients was 12%.

Sixteen per cent of neurologists reported that their involvement in the CODES trial changed their referral practice to psychiatrists/neuropsychiatrists for DSs. Both before and after their involvement in the CODES trial, the majority of neurologists agreed that psychiatry services should be involved in the care of all patients with DSs (before: median 4, IQR 3–5; after: median = 4, IQR 4–5; p = 0.1). However, only 55% said that they would have referred patients with DSs to psychiatrists/neuropsychiatrists before their involvement in CODES; for several respondents, this was because of a lack of local experts and resources.

Unsurprisingly, before their participation in the CODES trial, neurologists reported many different referral practices (Figure 13). Most neurologists referred patients with DSs directly to psychological interventions or to another professional who might then make this referral.

FIGURE 13 Referral practice prior to involvement in the CODES trial. (Note that multiple responses were allowed.) (Figure not reproduced here; see the original article.)

Neurologists’ confidence in recommending psychological therapy for DSs did not change as a result of their involvement in the CODES trial (before: median 4, IQR 4–5; during: median 4, IQR 4–5; p = 0.16). Although doctors reported having a good level of knowledge before the CODES trial of how psychological intervention may benefit patients with DSs, their ability to describe the psychological therapy offered to help patients with DSs improved during the study (before: median 3, IQR 2–4; during: median 4, IQR 3–4; p = 0.001).

Clinicians were asked to indicate their usual practice with respect to following up patients with DSs before, during and after their participation in the CODES trial (Figure 14). Overall, participation in the trial did not appear to affect how patients were followed up. Nonetheless, 26% of doctors indicated that the study had an impact on their practice relating to patients with DSs in other ways. Frequently reported changes included having more detailed conversations with patients; being better able to signpost patients and provide them with information; having greater confidence in the exploration of aetiological factors with patients with DSs; employing the CODES factsheet; making direct referrals for psychological treatment; making a greater number of referrals to other professionals; and feeling more confident making and delivering the diagnosis without stigma.

FIGURE 14 Neurologists’ usual follow-up practice for patients with DSs before, during and after their involvement in CODES. (Note that respondents could indicate more than one option.) (Figure not reproduced here; see the original article.)

CODES trial-related components

Doctors were asked their opinion on the usefulness of the different elements of the CODES care pathway and materials provided (Figure 15). Most doctors found all elements ‘very’ or ‘extremely’ useful, with particular emphasis on CBT for those patients who received it (86.1% of doctors) and the dissociative seizures factsheet (81.4%).

FIGURE 15 Ratings of the usefulness of CODES study elements. (Figure not reproduced here; see the original article.)

In addition, most neurologists reported that patient satisfaction for the psychiatric care (69.7%) and CBT (79.1%) within CODES was ‘very good’ (Figure 16), with 90% reporting that they would like this pathway to continue within their service. Overall, 91% of doctors also said that they would like to continue using the factsheet, with one specifically deeming it ‘extremely useful’ and suggesting that it offered ‘therapeutic benefit’ in itself. In addition, 84% of respondents reported referring their patients to relevant websites ‘often’ or ‘very frequently’.

FIGURE 16 Ratings of CODES study components. (Figure not reproduced here; see the original article.)

Around 84% of the neurologists reported ease of recruitment of patients with DSs to the study, as well as a general satisfaction of patients with their participation (> 69%). Despite this, doctors expressed more uncertainty with regard to keeping patients engaged (around 35% neither agreed nor disagreed), alluding to a level of difficulty in maintaining some patients’ engagement in the trial.

When providing additional thoughts on the CODES trial, positive comments included reference to raising awareness and understanding of DSs and that the pathway allowed patients quicker access to assessment and treatment of the disorder, avoiding existing waiting lists. The study also facilitated multicentred collaboration that was considered as a ‘lasting legacy of the trial’.

Two doctors said that they would like additional clinical resources to meet the increased clinical demand resulting from the CODES trial; another mentioned the problems faced by patients who had to travel long distances to receive treatment during the study.

Limitations

We acknowledge that there are certain limitations within this aspect of the process evaluation. There was a moderate response rate, with only 51% of the neurologists completing the online survey; consequently, this sample is likely to be biased towards those with a keener interest in the study and DSs and, therefore, the views reported here might not be entirely representative of the wider group of participating CODES neurologists.

Owing to responses being anonymous, we were unable to link responses back to practice in the study. Thus, for example, responses from individuals recruiting only small numbers of patients would have been based on limited experience within the study. In addition, results are exclusively based on self-report and may not reflect their actual practice.

Overall conclusions

Our process studies of patients, neurologists, psychiatrists and CBT therapists participating in the CODES trial highlight several common themes across the groups that have potential implications for future clinical practice in this area. These are in the context of an overall study that incorporated a care pathway, often specially devised for the project in certain services, that incorporated the involvement of neurologists/epilepsy specialists, liaison or neuropsychiatrists and CBT therapists (of varying levels of experience and professional backgrounds). Despite a general agreement among neurologists that their role in the care of DSs does not extend beyond diagnosis,167,168 it was not difficult to recruit a large number of these clinicians to take part in a trial that involved them playing a potentially larger-than-usual role in patient management. This suggests that previous research indicating neurologists’ resistance to be involved in the DS treatment process may be because of a lack of treatment resources rather than an objection to being involved in treating these patients or to psychotherapy per se.169 Although the pathway streamlined the service provision for patients, providing in many cases therapy that might not otherwise have been available, in some cases it led to increased service demand or demand for CBT that could no longer be met after recruitment ended.

Considerable value was placed across the different respondent groups on the quality of the diagnosis and its delivery, and the impact that this then had on patients’ apparent readiness for therapy. The fact that the diagnosis was delivered by neurologists and then restated by psychiatrists meant that therapists generally felt that patients coming for CBT were much better informed about the disorder than might normally have been the case. Psychiatrists also felt that the initial diagnosis delivery generally helped their engagement of patients. In addition to the usefulness of the diagnosis communication guidelines for neurologists, considerable value was placed on the two dissociative seizure factsheets. Neurologists wished to continue to be able to use these, and psychiatrists and patients recognised their potential value as being a resource to which patients could refer to help explain their disorder to others outside sessions. The factsheets were materials that psychiatrists found valuable for their teaching.

Neurologists responding to the survey clearly found the psychiatric assessment component of the care pathway useful; they were not specifically asked about the specialist background of those who might undertake such assessments, but interviews with both psychiatrists and CBT therapists gave the impression that those working with people with DSs should receive sufficient education/training in working with patients with DSs and FNDs more generally, often because of the complexity of patients’ presentations. We have commented elsewhere152 on the importance of the education of HCPs to avoid, for example, unnecessary mention of epilepsy in a manner that can derail engagement with psychiatric interventions as well as psychotherapy. Similarly important is education to prevent professional isolation170 and to prevent professionals holding negative attitudes to patients with DSs and functional disorders more generally.169

Importantly, before their involvement in CODES, the majority of participating neurologists were experienced in diagnosing and managing DSs and reported having a good understanding of how psychological intervention may be beneficial in this disorder. Nonetheless, despite their rates of patient diagnosis both before and after the trial, only around 50% were able to make direct referrals to a DS-specific psychological intervention. These results illustrate the need for more widespread resources specific to the disorder. Potentially related to this is the observation that 14 doctors (32.6%) reported that, during the trial, they were more likely to consider a DS diagnosis at an earlier stage of the assessment process. This may indicate that previously documented diagnostic delays for DS patients have been because of a lack of awareness of the disorder or access to treatment provision.171,172 Our findings indicate that many neurologists within the trial lost their ability to refer DS patients to psychological therapy once recruitment to the study had ended. This further demonstrates the issues surrounding a lack of access to psychological treatment for DSs and the importance of working to expand resources. It is noteworthy, therefore, that the vast majority (90%) of participating doctors reported that they would like the CODES care pathway to continue in their clinical service. Practical considerations for service roll-out, whether considering SMC alone or SMC with CBT longer term, would also include the need to deliver assessments and interventions that are local to patients, as travel was identified as a key barrier to involvement in sessions, made all the more relevant by the complexity of patients’ presentations and avoidance behaviour.

Patients and CBT therapists identified materials and techniques that were of clinical value and reflected, mostly positively, on the value of involving family members in the therapy, highlighting the potential role of significant others in maintaining a restrictive lifestyle for patients. Having written materials supported the content of therapy sessions and helped overcome patients’ memory difficulties.

Some of the psychiatrists said that they found it difficult to be asked to refrain from including CBT techniques in their interactions with trial participants. It would seem unlikely that these individuals, many of whom had some CBT training as part of their professional development, would opt to exclude these elements when working with patients with DSs in the future, although how this would be received both by patients and by therapists involved in delivering CBT to these patients, and how the intervention advice might conflict, cannot be determined from our current evaluation. Nonetheless, the involvement of a psychiatrist as well as a therapist potentially offered additional support for patients when addressing emotionally very difficult material, and again supports the impression of the importance of the entire care pathway. Close interprofessional working was also recognised as an important aspect of the study by CBT therapists.

Despite the disadvantage of not having been able to undertake in-depth interviews with a purposive sample of the neurologists involved in the study, overall our process evaluation does provide support for the overarching care pathway adopted in the study and for its individual components.