In-programme messages.

A randomised sample of anonymised in-programme messages was assessed for adherence to the trial protocol. Identifiable data (names including facilitator, patient or any other name mentioned in the message, IBD hospital or location) were deleted. Of 391 intervention group patients, messages for the first eighty patients were not retrievable from the database due to an unexpected database error, therefore 311 sets of messages between each patient and facilitator were available. Up to five cases from each facilitator were included in the analyses; where facilitators had a total caseload of five or fewer participants, messages to all participants were included. Where facilitators had caseloads greater than five, a random sample of five patients was selected. This resulted in a final sample of sixty-nine complete sets of messages. Randomisation was conducted anonymously by an independent research team at London North West NHS Trust. The mean number of completed sessions collated by fidelity sample appeared equivalent to the total sample (md = .24, p = .64) and the number of messages sent to and received from their facilitator (md = 1.0, p = .29). Coding was conducted by trial researchers (VW and SM), both trained in psychological interventions and cognitive behavioural methods. Ten cases were randomly selected for duplicate coding by both VW and SM for quality assurance. The remaining cases (n = 59) were split between VW (n = 30) and SM (n = 29) and independently coded.

Facilitator interviews.

Facilitators were recruited from participating UK National Health Service (NHS) IBD outpatient clinics (IBD nurse specialists) and from King’s College London (psychology graduates) involved in supporting delivery of the IBD-BOOST intervention. Semi-structured interviews were conducted at two timepoints using predefined topic guides (see S3 File), reflecting the different aims of each interview phase. Pre-intervention interviews were undertaken following facilitator training and explored participants’ professional background, expectations of the facilitator role, perceived preparedness and anticipated challenges in delivering a psychologically informed intervention. Post-intervention interviews explored facilitators’ experiences of intervention delivery, supervision, role development, and perceived barriers and facilitators influencing implementation. Interviews took place between January 2020 and October 2022 and were offered online, in person or via telephone according to participants’ preference (all chose online). Interviews were conducted by one of the two experienced qualitative researchers (WCD and LD), who were independent of both the intervention development and the host randomised controlled trial. Facilitators were invited to talk about their expectations, concerns, and experiences of supporting participants allocated to the intervention arm of the IBD-BOOST trial, including factors that aided or impeded delivery. Topic guides were developed and piloted by the research team prior to data collection to ensure clarity and relevance. All interviews were digitally audio-recorded and transcribed verbatim by an independent professional transcriber. Transcripts were returned to the research team for verification prior to analysis, and all identifiable information (e.g., names of individuals, places or institutions) was removed to ensure confidentiality.

In-programme messages.

A bespoke fidelity framework (S4 File) was developed for evaluating the novel IBD-BOOST intervention structure and assessing the cognitive behavioural approach of in-programme messages to trial patients. A tailored checklist was created using Walton et al.’s five-step process: assessing previous measures (none were appropriate), analysing the intervention, designing a coding system, confirming wording with the team, and piloting [18]. The initial framework was evaluated (using test data not included in the randomised fidelity sample) and refined, in consultation with the trial intervention team. The framework included: 1) Adherence to the trial protocol for sending messages; and 2) Using a cognitive behaviour approach within the message, and a comprehensive checklist of components, which allowed for individual tailoring and expected variability. Components were coded as: 0 (absence of content/inadequate fidelity), 1 (partial fidelity/deviations not appropriate/improvement needed), or 2 (competent fidelity as per protocol including appropriate deviations). Percentage mean (m) and standard deviation (sd) scores were calculated for continuous data. The maximum score for adherence to the trial protocol for sending messages was 14. The maximum score for using a cognitive behavioural approach within the message was 10. Total scores were calculated and reported as a percentage of total adherence. Comparisons between facilitators with a nursing background and facilitators with a psychology background were also conducted using independent samples T-test. Statistical analyses were conducted using STATA statistical software (version 17).

Facilitator interviews.

The data were analysed using reflexive thematic analysis to develop pattern of themes from facilitators’ standpoint [19,20]. This approach enabled identification and organisation of both the explicit and latent meanings within the data, supporting the development of meaning-based patterns grounded in facilitators’ experiences of training and intervention delivery rather than researchers’ preconceived assumptions [19,21]. Data analysis followed Braun and Clarke’s six-step approach to reflective thematic analysis recognising the iterative and interpretative nature of the analytic process rather than adherence to a rigid procedural framework [22] (see Table 3). The analysis was undertaken by two researchers (WCD and TYC), independent of both the RCT and the intervention development. Independent coding by two researchers enhanced the credibility and trustworthiness of the study findings [23].Regular discussions with a third researcher (LD) supported refinement and clarification of the themes and sub-themes. NVivo 14 software was used to facilitate data management and analysis.

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Table 3. Braun and Clarke’s six-step process of reflective thematic analysis and activities undertaken in each step.

https://doi.org/10.1371/journal.pone.0350560.t003

1.1 Professional background and previous experience.

Facilitators had different clinical backgrounds, with varying skills and knowledge. Some were nurses with IBD experience or research nurses with no previous CBT training, while others were psychology graduates without specific clinical training. Those with nursing experience raised concerns about their ability to adapt to the facilitator role due to a different mindset between being a nurse as a ‘fixer’ and a facilitator role as a ‘supporter.’

“I think my difficulty will always be just trying not to solve it [the symptoms] for them [patients] because as an IBD nurse I want to fix it because that’s what we do, we are fixers. So that’s going to be my biggest challenge.” (F7, Nurse, T1)

Facilitators with a nursing background, but without IBD experience, did not perceive this as a barrier to the facilitator role, since their limited IBD knowledge would prevent them from being able to advise on the clinical aspects of care. Facilitators with a psychology background also did not raise lack of IBD knowledge as a concern for adapting to the facilitator role.

“I haven’t worked with IBD before and my experience that’s relevant to my role here is working in long term conditions and understanding the physical symptom burden and how that relates to the psychological experiences that people often have.” (F11, Psychology graduate, T1)

1.2 The pragmatics of facilitator training.

Despite some facilitators feeling apprehensive about adapting to the facilitator role due to their clinical background, most expressed positive attitudes towards the overall training and felt well prepared for the role.

“I found it really reassuring in terms of giving me the feedback that I was going to have the necessary skills to deliver it … the content seemed to pitch perfectly in that it wasn’t too much detail but it stripped back some of the theoretical stuff around CBT and just gave you exactly what you needed to do the role.” (F11, Psychology graduate, T1)

Most facilitators described how they benefited from the practical aspects of the training, such as role-play and undertaking a practice patient, as well as the support and feedback received from supervisors. They felt that the training helped them to address any mindset conflicts between roles.

“…like the practice one you do with the patient, I’m quite keen to do that to get the feedback for what I do unconsciously that I think you just need to be a bit mindful throughout. …touching base with supervision throughout will be beneficial.” (F5, Nurse, T1)

All facilitators were issued with a training manual providing them with the resources to navigate the IBD-BOOST programme and support the patients. Despite the manual being a ‘big document’ that ‘needed time to scour through,’ all facilitators found the training manual very beneficial aiding the training process in skills and knowledge preparation.

“That’s my ‘go to’ document …all the templates, the guides for the phone call. They give you the beginnings of the sentence and leave you to do the rest and make it very personalised to who you are talking to and what you are talking about.” (F12, Nurse, T1).

1.3 Expectations and apprehension about becoming a facilitator.

The main motivation for wanting to become a trial facilitator was belief in the self-management approach to symptom management as a method of benefiting patients and wanting to learn CBT skills as an approach to be used in day-to-day practice.

“I like the idea of the self-care side of it in patients that are clinically in remission but are still having some symptoms that might not always be resolvable … helping patients be realistic about what they can do for themselves and promote that positivity of actually being in control.” (F8, Nurse, T1)

Facilitators talked about the role expectations and the necessity of having a specific set of therapeutic communication skills and ‘facilitator mindset’ to be able to support patients on their journey through the programme.

“… helping to motivate patients to continue with the programme, to encourage them to proceed but also to have empathy and understanding with them.” (F10, Nurse, T1)

“This is a very different one [role] because we’re not dealing with the causality, we’re helping break the cycle and the management. I found it quite difficult because …the nature of me being a nurse wants me to find the cause of what’s going on.” (F12, Nurse, T1)

Many facilitators expressed concerns and apprehensions about allocating designated time to the study, in addition to their substantive role and worried about time management and their ability to fulfil the role.

“When you go into a busy unit it takes one of your colleagues to be off sick that day and that session goes out.” (F6, Nurse, T1)

2.1 The skills and barriers to performing the facilitator role.

The motivation to become a trial facilitator went beyond their professional time, as many were prepared to dedicate their own personal time (days off and evenings) to fulfil the role, e.g., to attend the training and to run the sessions with the patients. Those who delivered the programme in their own time were remunerated on a sessional basis.

“I’m doing this outside of my working hours because I feel like there is actually a gap in healthcare service and CBT …I really felt like they [patients] will benefit hugely from CBT model in managing their symptoms.” (F4, Nurse, T1)

Others tried to incorporate the facilitator’s role into their daily routine or designate a specific time and day each week to create a better structure to support their new additional responsibilities.

2.2 The pragmatics of supervision.

All facilitators had access to individual and group supervision, and this was well received as it provided support, guidance and encouragement. Individual supervision was perceived as ‘immediate’, ‘specific’ and ‘in-depth’ targeting individuals’ needs, feelings and concerns.

“… quite reflective and constructive and … allow me to gain in confidence, also if you had any anxieties about a patient if they weren’t engaging…it’s nice to talk that through.” (F6, Nurse, T2)

Group supervision was perceived as an opportunity of ‘learning’, ‘reflecting’, and ‘solving’ of broader issues that all facilitators encountered. Many facilitators highlighted the benefits of ‘multidisciplinary’ perspectives and being ‘part of the team’ during the COVID-19 pandemic and working remotely. However, some facilitators found it difficult to share their experience in a group situation, as they felt judged, and for that reason they preferred individual supervision.

“The individual session feels a bit safer, and you feel less judged. Not that anyone is ever judgemental, but you do feel like if you say something and you’ve got it wrong, I would feel quite uncomfortable.” (F19, Psychology graduate, T2)

Some facilitators emphasised negative emotions that may arise from the role, and the supervision sessions aided them with support, guidance and the opportunity to reflect.

“It can be quite difficult supporting people, and I think an important part is to be able to share and say that was a really difficult phone call or a message that was quite distressing or something.” (F11, Psychology graduate, T2)

2.3 Practice led to role clarity and confidence.

All facilitators mentioned that they became more ‘familiarised’ and ‘confident’ with the role with more practice. Though they experienced a ‘learning curve’ facilitators enhanced their facilitating skills and grew in confidence over time. They felt training was ‘sufficient’ and prepared them well for the role.

“I think it’s more of a confidence growing exercise for the facilitator and that comes with time.” (F6, Nurse, T2)

“It’s sufficient for the purpose, otherwise I think if you knew too much it’s almost like you could possibly step outside the boundaries of what being a facilitator is meant to be, so I think it’s good.” (F11, Psychology graduate, T2)

Importantly, many facilitators found that initial concerns about conflicts in mindset and skills between facilitator and their speciality background were addressed through practice in intervention delivery.

“I think I was quite apprehensive about it from the training, but I think the more patients I facilitated, the better that you get.” (F15, Nurse, T2)

Facilitators grew in confidence and clarity of the role as the study progressed and this was evident in their answers in interviews at T2.

“Actually, being a facilitator and delivering the study has not been easy, but not as burdensome as I thought. … Helping people to accept it was very enlightening for me as a healthcare professional.” (F12, Nurse, T2)

3.1 The practicality of facilitator role in intervention.

All facilitators felt that the telephone session and weekly in-programme messaging had a beneficial effect on patients’ involvement with the programme, helping them to be more motivated and engaged.

“It’s a crucial part of building the rapport … I think it adds something to the relationship between the patient and the facilitator and then the ongoing messages. I think that’s evidenced by the messages you get back from people that specifically comment on the support that you’ve given them.” (F11, Psychology graduate, T2)

The telephone session was regarded as ‘crucial’ to provide the overview and clarity of the intervention to the patients, enhancing their engagement and commitment to the programme. Continued support in the form of weekly messaging was seen as valuable to address patient queries and to motivate them.

“I do think some people probably would be fine just to have the phone call and then just go off and do it themselves, but I don’t know how much they are getting out of it. So yes, I think it’s[messaging] necessary.” (F19, Psychology graduate, T2)

Some facilitators suggested that after the telephone session, their involvement could be optional instead of necessary as it may not suit everyone, particularly when patients are highly motivated and self-directed. However, others suggested a greater number of telephone sessions (two or three in total) were needed throughout the duration of the intervention to build a stronger relationship and support patients’ engagement.

“I think some people don’t need a facilitator going through the programme because they’re quite independent. Other people I think like that, and like that accountability, like being prompted to reflect and share further experiences.” (F19, Psychology graduate, T2).

3.2 Reflections and suggestions on the intervention design.

Facilitators viewed the generic programme sessions (cognitive behavioural content relevant to all symptoms) to be as valuable as the symptom specific sessions on fatigue, pain and urgency/ incontinence.

“I like the structure. I like the natural progression of the different sessions.… The six core sessions will give you the principles to manage those three, because these are long term symptoms for a patient with IBD. But I also like the fact that they provide symptom specific sessions.” (F4, Nurse, T2)

Facilitators presented extensive evidence demonstrating that the content of the intervention addressed patients’ needs.

“I definitely have received a lot of positive messages and it has been amazing really to be part of this journey for a large number of my participants [patients] and yes some of whom have had the condition for 20, 30, 40 years and have seen a change, but as I say, I think it’s about just trying to get those people that it’s the right time, it’s the right everything for them.” (F17, Nurse, T2)

Regarding the digital format of the intervention, all facilitators expressed positive attitudes to the online intervention, as it could be easily ‘accessible’ to many people, providing ‘flexibility’ and ‘convenience’.

“I think patients found it good. They could use it at any time of the day. It’s convenient for them, they can do it on the train home.” (F10, Nurse, T2)

One frequent suggestion was to add extra phone calls mid-programme, and at the end of the programme. Feasibility of adding extra calls were considered by some facilitators in terms of resources and access to patients.

“It would have been nice to have a final phone call.... It’s not always that easy to arrange the phone call, get access to people’s busy days.” (F11, Psychology graduate, T2)

A second, frequently suggested change to the programme was to include patient activation measures (e.g., a behavioural assessment tools), that would help to assess the level of patients’ involvement from being passive to being proactive with regards to their symptom self-management. This would help to identify those with different engagement levels and determine if they need facilitator support.

“We have this in the NHS, as well as in my team, that we assess the patients’ activation measure. So, patients who are really activated they can self-manage, basically they can use the self-management tools. But there are those patients who are also in between, and they need a bit of handholding or a bit of a someone to reassure them.” (F4, Nurse, T2)

Some facilitators commented on the linear design of the programme potentially contributing to patients losing interest, as the initial more generic sessions may be irrelevant to their needs and not addressing their symptom burden.

“I think maybe the people that have had a really long diagnosis, they are also the kind of people that would drop off after session two or session three because they’re like oh I know everything. But then they haven’t unfortunately ever then reached sessions that probably would have been most helpful where in the call they’ve maybe said explicitly that I have really irrational thoughts sometimes around my IBD and it stops me from doing things.” (F19, Psychology graduate, T2)

Hence, to reduce drop-out, the order of the sessions should be less restrictive, giving patients flexibility on which sessions they would like to complete.

3.3 Reflections and suggestions on practical issues navigating the online platform.

Facilitators commented on the practicalities of the facilitator platform; however, their comments were polarised. Some found the platform ‘easy’ to navigate and valued its functions, such as the calendar for booking telephone sessions and checking patients’ engagement in terms of frequency and duration of log-in. Others found the platform ‘clunky’ and suggested that functionality had to be improved.

“You might be composing a message, and things would time out in the background, and you’d lose the whole message. So, I overcame that by putting messages into Word documents in the first place so that that didn’t happen.” (F7, Nurse, T2)

3.4 Suggestions on supervision.

A frequently reported barrier in attending the supervision sessions was limited time and capacity. Suggestions were made to add more supervision slots, providing more flexibility for facilitators.

“I’m not sure if a weekend group supervision might work because obviously it’s quite precious for us working full time but different time slots I think might potentially work.” (F4, Nurse, T2)

Despite the challenges, facilitators expressed their satisfaction with the online supervision sessions rather than face-to-face, as this provided flexibility and ease of access.

3.5 Factors that may be considered for future implementation.

Facilitators agreed as to the benefit of the intervention, as they perceived it an ‘excellent resource’ for patients, addressing the gap between current healthcare and patients’ unmet needs.

“I think it [the intervention] takes people through their symptoms step-by-step helping them to understand what’s going on from the physiological and psychological points of view.  ... If done well, if people followed the steps and followed the route then they’d get the maximum benefit from it.” (F7, Nurse, T2)

Sharing the hopes for the intervention’s beneficial impact on people with IBD affected by fatigue, pain and urgency/incontinence, all facilitators expressed their optimism in the intervention being implemented in the NHS healthcare system.

“I think it should be part of NHS treatment because mental health has a big impact on patients’ physical wellbeing and vice versa. They are both interactive.” (F10, Nurse, T2)

Considering the limited NHS resources, some suggested that the intervention could also be implemented via charity routes to enable patients’ access to self-management programme.

“Some people get these things [symptoms of fatigue, pain, and urgency/incontinence] even when they are clinically in remission. So maybe a separate hub for delivering this facilitator role that separates it from their usual relationship with their IBD nurse might work very nicely.” (F5, Nurse, T2)

To enable realistic and successful implementation of the intervention, facilitators suggested considering the capacity and structure of the facilitation model and what the facilitators’ background should be.

“It [supervision model] has to be tailored for that specific IBD service, but because every IBD team is different and it might be useful to open it up, as I said with the right training package and supervision to other members of the healthcare team.” (F4, Nurse, T2)