Facilitators and barriers to participation of patients with treatment resistant depression in a randomised controlled trial of two forms of personalised magnetic resonance imaging targeted transcranial magnetic stimulation (the BRIGhTMIND trial)

Abstract

Background

Magnetic resonance imaging (MRI) can personalise the site of transcranial magnetic stimulation (TMS) delivered as a course of 20 sessions for treatment-resistant depression (TRD). Facilitators and barriers to a randomised controlled trial (RCT) of MRI personalised TMS is understudied.

Aim

Qualitative analysis to explore facilitators and barriers behind RCT participants’ experience of personalised MRI-targeted TMS in people with TRD.

Methods

Nineteen participants from the BRIGhTMIND RCT of two forms of MRI personalised TMS, completed semi-structured interviews exploring the reasons behind the uptake and experience of TMS. The sample included fifteen participants who completed the treatment course and four who declined to proceed before randomisation. Interviews were analysed using thematic analysis, co-produced between researchers and patients and public involvement contributors.

Results

Facilitators were “hope” regarding the treatment itself, the influence of research staff, interest in a new treatment, and altruism. Barriers were concerns about their ability to commit to the trial and the nature of the TMS itself. Throughout the themes, clinicians and researchers made a difference by explaining and setting realistic expectations of the treatment and building rapport through daily patient contact.

Conclusion

The study highlights the importance of understanding patients’ concepts and experiences of TMS. The provision of optimal information to patients twinned with offering TMS outside office hours and the most efficacious, acceptable regimes of TMS delivery may maximise participation (Trial registration number ISRCTN19674644, registered on 01/10/2018).

Trial Registration

Trial registration: ISRCTN19674644||http://www.isrctn.org/) registered on 01/10/2018.

Trial Identifying numbers: CPMS 39297, IRAS 245025.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12888-025-06893-2.

Introduction

Transcranial magnetic stimulation (TMS) is a National Institute for Health and Care Excellence (NICE) approved intervention using the application of magnetic pulse to change brain activity for both depression and treatment-resistant depression (TRD) [22]. However, it is still only available as a clinical intervention in a minority of mental health services in the UK and internationally. Repetitive TMS (rTMS) is the traditional form delivered at a standard site in 37.5-min sessions on 20 or more occasions. Benefits typically only last 1–3 months with a high degree of variability between individuals [13, 22]. Intermittent theta burst stimulation (iTBS) is an alternative patterned form of TMS that mimics the brain’s natural electromagnetic rhythm producing long-term and therefore might be effective for a longer duration of time [16]. It is equally effective for treatment-resistant depression [3, 5, 21] and requires a shorter duration of administration [3], thereby increasing patient throughput in a clinical TMS service.

Whilst evidence suggests that TMS in depression is generally well-tolerated [9], only a small number of studies have investigated the facilitators and barriers to accessing TMS treatments for depression or other conditions. Clinicians have been identified as having an important role in facilitating engagement in TMS. This role goes beyond just delivering TMS treatment to include engaging in constructive therapeutic conversations, providing a relaxing and friendly environment, and supportive long-term management [18, 26]. Patients’ initial impression of TMS and the equipment used to deliver it is thought to be a decisive factor, influencing both their perceptions of treatment effectiveness and also causing fear and apprehension in some [26].

Whilst prior research provides some implications for practice guidance in engaging patients with rTMS, the facilitators and barriers to recruitment to a research trial offering rTMS or iTBS have not been explored. We conducted qualitative interviews that ran parallel to the BRIGhTMIND study, a multi-site RCT in which patients with TRD received 20 sessions of either rTMS or connectivity-guided intermittent theta burst stimulation (cgiTBS), a form of iTBS [20, 21, 24]. The aim was to explore the barriers and facilitators to the recruitment of participants in the trial from a qualitative perspective whilst understanding the factors influencing patients decisions to participate and informing best practice for recruitment strategy in the field of neuromodulation treatments.

Methods

The study employed a qualitative analysis of semi-structured interviews conducted with participants in the BRIGhTMIND trial. Ethical approval was provided by NHS Research Ethics Committee (ref: 18/EM/0232). In the BRIGhTMIND trial, 255 participants with TRD were recruited. They were informed that we were testing two different forms of TMS treatment that were personalised using MRI scans and neuronavigation—allowing for precise targeting of the coil placement area (rTMS versus cgiTBS), to extend the duration of improvement in depression symptoms from 1–3 months to 6 months. They were to be randomised to one of these two treatments and they would need to attend a baseline assessment and MRI scan, complete 20 sessions of TMS over 4 -6 weeks delivered by a certified clinician, have further clinical assessments at 8-, 16- and 26 weeks post randomisation, with a further MRI scan at 16 weeks. They were provided further information on potential adverse effects and details on the procedures involved in the trial. We provided materials showing how we approached clinicians and participants, including changes as a result of the COVID-19 pandemic, and our recruitment strategy (see supplementary material 1–4).

Data collection

Three sets of participants were anticipated to be recruited to this study using purposive sampling: i) participants who completed TMS treatments were invited to participate after their 26-week follow-up assessment; ii) participants who withdrew from the main BRIGhTMIND trial during or after commencing TMS treatments – thus, did not complete the treatment course (i.e. withdrawn participants); and iii) participants who had returned a reply slip to the research team expressing interest in the main BRIGhTMIND trial, but declined to participate before being randomised (i.e. declined participants). Recruitment took place across four of the five UK NHS sites participating in the main trial.

Eligible participants were sent an invitation letter, an information sheet highlighting the aims and content of the study, a copy of the consent form, and a reply slip for the interview study. Those that returned reply slips expressing interest were contacted to schedule an interview, conducted by researchers working on the main BRIGhTMIND clinical trial with experience in conducting qualitative interviews. Before the interview, the researcher reviewed the information sheet with the participants, who were then given the opportunity to ask questions, before giving consent to participate. Written consent was obtained for face-to-face interviews, and verbal consent was obtained and formally recorded for telephone interviews. Interviews were recorded on an encrypted digital voice recorder and transcribed using a professional transcription service.

The interviews were conducted between October 2019 and March 2022 and lasted between eight and 26 min. Five were completed in person, whilst the remaining interviews were conducted remotely due to either participant preference or COVID-19 pandemic-related restrictions.

Semi-structured topic guides developed for this study in collaboration with a group of people with lived experience of TRD were used to explore participants’ experiences of the facilitators and barriers to taking part in the BRIGhTMIND RCT which involved either receiving rTMS or cgiTBS [20]. Topic guides included four broad questions: (1) how they found out about the trial; (2) their initial reaction on hearing about the trial and treatment involved; (3) the factors that motivated their decision about participation; (4) whether they had any concern about taking part in the trial. Participants who received TMS treatments as part of the main BRIGhTMIND trial were also asked about their experience of the trial and the acceptability of the treatment, which will be reported in a separate paper. Topic guides can be found in the supplementary materials 5 and 6.

Participants

Out of the 255 BRIGhTMIND trial participants, we randomly invited a portion of participants (to reflect a mix of demographics, sites ect. and Nineteen were interviewed: seven from the Nottingham site, seven from the London site, three from the Northampton site, and two from the Newcastle site; aged 29–67 years (M = 49.7, SD = 12.6 years). We did not recruit any participants from the Oldham site who joined the study after March 2022. The participants included ten males and nine females, with 17 (89.5%) white (British or other), and the remaining two participants of Asian or Asian British ethnicity. Eight (42.1%) participants were in full-time or other employment, seven (36.8%) were unemployed and four (21.1%) were retired. Fifteen (78.9%) of the interviewed participants had completed the full cycle of TMS treatments and follow-up assessments, and four (21.1%) had declined to participate in the trial before randomisation into treatments. None of the participants who withdrew from the trial during or after treatments returned the reply slips expressing an interest in this study. Of those that completed treatments, seven (36.8%) participants received rTMS treatment and eight (42.1%) received cgiTBS treatment. See Table 1 for more information.

Table 1.

Participants’ demographics

Service User ID Code	Site	Participation in trial	Treatment arm
1	Nottingham	Full	rTMS
2	Nottingham	Full	rTMS
3	Nottingham	Full	Cgi TBS
4	London	Full	rTMS
5	London	Full	Cgi TBS
6	Nottingham	Full	rTMS
7	Northampton	Full	rTMS
8	Northampton	Full	Cgi TBS
9	London	Full	Cgi TBS
10	Newcastle	Full	Cgi TBS
11	Nottingham	Full	Cgi TBS
12	Newcastle	Declined	n/a
13	London	Declined	n/a
14	London	Declined	n/a
15	Northampton	Declined	n/a
16	Nottingham	Full	Cgi TBS
17	London	Full	rTMS
18	Nottingham	Full	cgiTBS
19	London	Full	rTMS

Data analysis

An inductive thematic framework analysis approach was used [10, 25]. Initially, transcripts were repeatedly read by two researchers (CB and LW) before coding, to allow researchers to familiarise and become immersed in the data before coding six of them separately [23], to ensure consistency and reliability of coding [17]. One researcher (CB) coded the remaining 13 transcripts. The initial codes identified the interesting and most relevant features of the data, focused on the research objectives. Researchers (CB) and (LW) reached consensus that data had reached saturation after coding 12 transcripts, as no new or meaningful codes emerged [15], therefore, no additional interviews were required. However, after this, some further interviews were conducted to see if any new data was identified due to the COVID-19 pandemic. Following this, researchers (CB and LW) summarised the initial codes into broader categories. To ensure rigour, a collaborative discussion was held with the principal investigator and qualitative lead (LT) to further refine and agree upon the overarching framework of themes, including facilitators and barriers. Consensus on the main sub-themes was achieved through an iterative process of reviewing and comparing coded data, grouping related categories, and ensuring alignment with the research objectives. The refined framework was then input into a matrix using Nvivo 12. The research team scrutinised the final structure and codes which aided the refinement of the framework by renaming, merging/removing themes and sub-themes.

The framework of themes and sub-themes were presented to the main trial’s patient and public involvement (PPI) group and then to researchers involved in the BRIGhTMIND study recruitment, for feedback and to support the interpretation of the findings. This allowed us to check the credibility of the analysis and results, further improving the trustworthiness of the results [17]. The results were also used to inform the main trial’s ongoing recruitment and other procedures, demonstrating their transferability [17].

Results

Themes and sub-themes are summarised in Table 2.

Table 2.

Themes and sub-themes

Facilitators	Barriers
Hope	Commitment concerns
Influence of staff	Treatment-related concerns
Interest in new treatments
Altruism

Facilitators

Participants exhibited hope and optimism towards the innovative TMS treatment, driven by the desire for an effective alternative to medications. Positive interactions with compassionate and supportive staff, a desperate need for relief from TRD symptoms, and a sense of altruism towards helping others were key factors that motivated their participation and engagement in the trial.

Hope

Supplementary material 7, Table 1 shows the subthemes to the hope theme with supporting quotes.

Keen to try alternative treatments

Participants’ enthusiasm to get better translated into openness towards the innovative treatment. There was optimism and hope that TMS treatments could help where other treatments had previously failed in relieving their depression.

The positivity and hope stemmed from TMS being a different type of treatment option that targeted the cause of depression and “what physically happens to the brain rather than simply testing chemical levels” (Participant 14). Participants believed that this offered a credible alternative to pharmacological treatments.

Grateful for opportunity

Participants also expressed feeling grateful and privileged that they were offered the opportunity to receive this treatment which affirmed an aspiration to get better. Participants felt glad that their symptoms made them eligible to access the treatment as if their participation was a reward and an acknowledgment of their severe depression.

For those who were already considering rTMS treatment, paying for treatment was deemed unaffordable and the waiting time within the National Health Service (NHS) Trust where rTMS is available was too long.

The study design itself was attractive due to the access to treatment in both arms so participants understood that taking part in the trial would guarantee some form of TMS treatment “because there wasn't an arm where you don't get treatment” (Participant 3).

Influence of staff

This theme reflects the positive impact that staff had on participants’ experience which in turn supported their engagement in the main trial. Subthemes and supporting quotes are shown in Table 2 of supplementary material 7.

Positive interactions and experience

All staff came across as “wonderful, very professional and fully informed” (Participant 2) whilst also being “compassionate and very sensitive” (Participant 3) which contributed to patients feeling comfortable and knowing what to expect from the treatment.

During sessions, interactions with patients via quizzes and games created by the clinicians, tailored to participants' prefernces (such as music-themed quizzes), or discussions about shared interests improved the patients’ experience such that time went faster and the sessions were more pleasant.

Overall, the staff made the daily commitment more acceptable.

Reassurance about treatment

Staff had an important role in reassuring participants about the treatment. Concerns and fears could be raised by participants and discussed freely with staff who listened and were able to provide appropriate reassurance which “allayed those fears” (Participant 3).

Staff were accommodating and flexible during the sessions, making the patients feel at ease, relaxed, and supportive when participants needed to cancel the occasional appointment. Participants had to complete the 20 sessions within six weeks with no more than four days between sessions. As a result, the caring staff contributed to reducing stress and anxiety triggered by the treatment itself. One participant even likened the environment and attentiveness of staff to going to a spa.

Seeking relief from depression

Table 3 of supplementary material 7 shows the subthemes and supporting quotes. This theme reflects the shared experience of participants dealing with TRD, who, despite trying many different treatments before, continued to experience difficulties with everyday life.

Desperation to try new treatment for depression

The treatment-resistant nature of participants’ depression caused frustration but also a sense of desperation that meant they were willing to try any new treatment, even an experimental one, that might help relieve their symptoms.

Most participants had a long history of various treatments and “multiple different medications” (Participant 2) they had taken for depression, but many reported that “nothing has ever changed” (Participant 5), and sometimes, their negative feelings were worsened by medication. Therefore, they were particularly open to non-pharmaceutical treatments.

The chance to improve their quality of life made the treatment and trial appealing, even if they may have been pessimistic that the treatment may not work. The research process was seen as key to introducing new effective treatments for depression whilst also advancing the knowledge about depression. As participants were keen for new treatments to be introduced, they felt motivated to take part in the trial.

Treatment with fewer side-effects

The safety and non-invasive nature of the treatment added to the interest as the treatment was perceived as incurring fewer possible side effects than medications. Participants felt reassured after being told that they could resume their everyday roles and tasks after each session.

The participants were accustomed to side effects from the antidepressant medications they had tried so there was an expectation of some side effects, but they were perceived as being minor compared to the potential benefits. Furthermore, the location of the treatment within the NHS sites ensured the availability of medical support in the event of an adverse event, and this provided reassurance and “made me feel very safe” (Participant 15).

Altruism

Whilst participants were keen to join the study for the potential benefits to their own mental health, they also expressed an interest in wanting to help others in a similar situation. This altruism contributed to their decision to participate. Some felt that participating in the study would be useful even if the treatment was not effective for them. Quotes for this theme can be found in Table 4 of supplementary material 7.

Barriers

Significant barriers to participation in the TMS treatment trial were reported such as commitment concerns stemming from the challenge of attending daily sessions for a month, which disrupted participants' routines and work schedules, particularly for those who were employed or dealing with poor health. Treatment-related concerns highlighted fears about potential side effects, especially in comparison to Electroconvulsive Therapy (ECT), and anxiety about the unknown sensations of the treatment, which together deterred some individuals from engaging in the trial.

Barriers to taking part in the study were experienced by both those who were recruited and completed the treatments and those who declined to participate. For some, the barriers did not prevent engagement in the trial or the treatment. However, for others, those barriers and concerns outweighed the positives and potential benefits and led them to decide not to participate in the trial.

Commitment concerns

Table 5 of supplementary material 7 outlines subthemes and supporting quotes.

Having to attend daily sessions

The treatment requirement of having to attend daily sessions for almost a month was a commitment that acted as a barrier to participation in the trial. The frequency of attendance was described as intense and requiring a new daily routine to be built around the treatment.

With treatment sessions taking place at different times every day and only during business hours, fitting the sessions around work was difficult for participants who reported having to use annual leave and sick leave to attend. Therefore, the treatment was more accessible for those who were self-employed or not working. Even those who were retired described that the “commitment to attend for a period of days” (Participant 14) clashed with other commitments and was challenging.

Concerns about attendance due to poor health

In addition, there were also specific concerns about not being able to attend the daily sessions because of feeling too unwell due to their mental health, or because of common illnesses such as getting a cold, sickness bug, or COVID-19. This reflected difficulties with making daily commitments or leaving the house which are often described by those with depression and/or anxiety.

Once out of the house, anxiety related to facing the prospect of commuting or finding parking was highlighted as a barrier, particularly in participants who were not comfortable with crowds or relying on public transport. These concerns were heightened during the COVID-19 pandemic when recruitment to the trial resumed after being closed for six months, when people were worried about mixing with others either on public transport or on NHS premises.

It is worth noting that, although initially perceived as a negative experience, getting out of the house was later viewed positively by the participant. This shift occurred because it provided them with a routine and encouraged them to push beyond their limits [28].

Treatment-related concerns

Other concerns that acted as a barrier to participating in the trial were directly linked to the nature of the treatment. Table 5 of supplementary material 7 outlines subthemes and supporting quotes.

Fear of side effects – comparison with ECT

Participants drew comparisons between rTMS/cgiTBS and ECT and these associations triggered fears of potential side effects such as memory loss. In one of the trial sites, the location of the treatment room was next to the ECT suite which caused further anxiety and brought back negative memories for participants who previously received ECT or knew of people who had negative experiences of ECT.

The comparison with ECT heightened concerns about the side effects of TMS which were feared to be memory loss and epileptic seizure, despite the comparative safety of the TMS treatment. The fact that participants were told that they would be able to drive back home after each treatment session reassured them as it emphasised that the treatment was non-invasive and side effects were unlikely.

Not knowing what to expect

Beyond the association with ECT, the uncertainty regarding sensations produced by the magnetic stimulation and the fear of pain caused anxiety and was a barrier to taking part.

The fears seemed to be linked to the magnetic stimulation making direct changes to the brain which was perceived to be “quite a weird [idea]” (Participant 3). Some participants were concerned that the treatment could make their situation worse.

Discussion

The study identified facilitators and barriers to taking part in TMS treatment as part of a clinical trial for those with TRD. Key facilitators were the hope that this treatment would prove effective in treating their own TRD and help others by taking part in the research to test new treatments, and staff providing reassurance and support throughout the recruitment and treatment processes. Acceptance of the TMS treatment being offered was rooted in the hope that it would help improve their depression symptoms and driven by the treatment-resistant nature of their depression and a history of unsuccessful or difficult-to-tolerate treatment experiences.

These findings match the themes of “treatment resistance”, “side effects from other treatments” and “desperation for relief” found in the content analysis of emails from patients self-referring to TMS treatment [7], and confirms that participants with negative experiences of antidepressants through side effects or lack of effectiveness were more motivated to take part in new treatments [14]. Participants were keen to see new forms of treatment for depression with fewer side effects than medications, driving their interest in taking part in research. Whilst they were hoping for their own symptoms to improve, participants were also motivated to take part in the trial because it might have positive impacts on society by helping others with depression.

Staff professionalism and the quality of their relationship with potential participants also affected the decision to take part. Researchers and clinicians made patients feel at ease, and comfortable to ask questions and share concerns. Staff reassurance through explaining TMS treatment and its non-invasive nature was a key facilitator as reported previously [18]. The current study also shows that providing reassurance at the point of recruitment facilitates the decision to take part. Through reassurance and being approachable, clinicians have an important role in forming patients’ first impression of TMS through to the end of treatment. In previous studies in patients with chronic musculoskeletal pain, the first impression of TMS was identified as a decisive factor in accepting treatment, and lack of knowledge and understanding about treatment was the main barrier to TMS treatments [26].

The main barriers to taking part in the trial were related to the commitment to the trial regime and the uncertainty around the nature of the treatment. In this trial, patients attended daily TMS sessions for four weeks. This expectation caused concerns as participants worried about not being able to leave their homes to attend sessions due to depression and anxiety. These emotional responses to the invitation to participate are likely to be related to the participant’ symptoms of TRD. However, the interviewees who declined participation in the trial also commented on commitment issues related to work obligations. As such, the treatment seemed more accessible to those with more flexibility, such as the retired or self-employed. A few studies have explored accelerated TMS treatment whereby the 20-session delivery is condensed into one week [2, 6, 8] which might significantly reduce the impact of the work commitment barrier. It is important to note that while significant commitment barriers existed, they were not experienced in isolation. These barriers were often mitigated by participants’ hopes, optimism, and desire to improve their well-being or contribute to helping others through research. As such, these factors, recognised as the main motives behind trial participation [11], are crucial considerations, as they can outweigh treatment-related concerns.The experimental roots and novelty of the treatment also proved stressful for patients as they did not know what to expect from it, which was especially difficult for those who experienced comorbid anxiety. The concept of TMS evoked associations with ECT, which was negatively perceived due to known historically reported side effects, e.g. short-term memory loss, although TMS has been associated with improvements in working memory and attention [4, 12]. Given the critical role of clinician support in addressing participants' concerns, it would be beneficial for clinicians to highlight the evidence supporting TMS’s positive cognitive effects while clarifying its distinctions from ECT before commencing the trial. Such discussions could help alleviate participants' apprehensions and build trust in the treatment.Recruitment for the trial was likely impacted by the COVID-19 pandemic. Participants faced heightened stress and anxiety due to the in-person nature of the treatment, which required daily hospital visits for four weeks. This added to the anxiety they already experienced as a result of their TRD. These findings align with existing literature indicating that the COVID-19 pandemic disrupted research recruitment due to perceived risks associated with in-person participation [19]. In this particular study, the TMS treatment could not be conducted entirely remotely; however, adjustments were made to move the assessment and consenting processes online to mitigate these challenges [1].

Research and clinical implications

The findings in this study highlight the critical role of clinicians as facilitators of TMS for patients with TRD. Whilst being approachable and showing empathy, they should be prepared to explain the treatment to patients, reassure them about the side effects, and clarify the differences between TMS and ECT. Clinicians need to be able to describe the TMS sensation to patients and illustrate the treatment journey whilst monitoring patients’ expectations of the treatment. Some flexibility around the treatment schedule is key such that if patients cannot attend one session, another one can be booked within the treatment timeframe, which should be communicated to the patient before commencing treatment.

Given the TMS commitment, availability might be an issue for patients with more rigid schedules (e.g., work). Offering treatment in the evening as an alternative will prove useful for patients. Alternatively, the effects of accelerated TMS treatment sessions delivered over one or two weeks might also be more feasible for the working population wanting to access TMS treatments [27].

Strengths and limitations

A strength of the study is that we deliberately conducted the interviews and qualitative analysis before recruitment to this large multicentre trial had ended and without knowledge of the results of the trial. The main results of the BRIGhTMIND trial are now published, showing that the study was adequately powered with no difference between either treatment arm but a clinically substantial treatment effect of more than seven points with both forms of TMS on the primary outcome measure, the 17-item Hamilton Depression Rating Scale at 8, 16 and 26 weeks [21].

There are several limitations to the study. Firstly, despite the consensus that data had reached saturation, the sample size was small (n = 19), which may limit the generalisability of the findings. Moreover, none of those who withdrew during or after the TMS treatment chose to take part. This exclusion likely led to an underrepresentation of negative experiences, as such participants might have identified additional barriers to participation, posing a risk of sample bias. Possible reasons for not choosing to talk about their experiences on the trial may relate to an unwillingness to be interviewed by the same researchers who enrolled them in the main trial. Future research should conduct the qualitative work independently of the main trial.

Part of the trial took place during the COVID-19 pandemic. Whilst most of the interviews were conducted with participants who completed the treatment before the start of the pandemic, we interviewed three participants who received treatment after March 2020. These understandably highlighted commitment concerns as a barrier to recruitment. However, the same topic guide was used throughout so the specific effects of the COVID-19 pandemic on decision-making about participation in the trial or in TMS were not explored in depth.

Another limitation relates to the NHS schedule and the availability of staff within NHS settings. Unlike some private practices that offer TMS treatment over extended hours, including evenings and weekends, the NHS provides more limited time slots. This may have contributed to accessibility barriers for participants. As such, this limitation is specific to the healthcare system and not to TMS therapy where the trial took part itself, as private clinics worldwide may provide significantly greater scheduling flexibility.

Lastly, some participants expressed interest in accelerated TMS protocols. It is worth noting that such protocols, like the recently FDA-approved SAINT protocol [8], are already available in some countries. Future research should explore participant preferences for different TMS protocols and how these preferences might impact engagement and outcomes.

Conclusions

Taking part in a clinical trial of TMS treatment for those with TRD was influenced by various factors. Many participants were motivated by hope in the effectiveness of the treatment for their own symptoms and potential help to others. However, this optimism was tempered by doubts and fears. Beyond the fear of COVID-19 infection, the barriers to engaging with the trial were uncertainty about committing to attend daily sessions for four weeks and concerns about the nature of the treatment, particularly its perceived association with ECT. Reassuring and supportive clinical and research staff played a key role in fostering a sense of safety and trust.

Authors’ contributions

Clement Boutry: Conducted interviews, analysed transcripts (coding), developed themes and subthemes, interpreted findings, and drafted the manuscript. Lucy Webster: Second-coded some of the transcripts, developed themes and subthemes, interpreted findings, reviewed the manuscript, liaised with patient involvement, and reviewed the manuscript. Louise Thomson: Designed and supervised analysis, interpreted findings, and supervised and reviewed manuscript writing. Peter Bates: Led the patient involvement group, reviewed the study design, interpreted findings, and reviewed the manuscript. Rebecca McNaughton, Joanne Ooi, Jane Eastham, John Gledhill, Andy Willis & Sonal Marner: Reviewed the study design, interpreted findings and reviewed the manuscript. Delilah Harding, & Isabel Reid: Conducted interviews and reviewed the manuscript. Richard Morriss: Chief investigator of the main trial, supervised the study, and drafted the manuscript.

Funding

This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and National Institute for Health and Care Research (NIHR) partnership. Magstim plc supplied TMS delivery and neuronavigation systems.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures involving patients were approved by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. All participants were notified about their rights before interviewing and provided an informed consent to participate.

Competing interests

The authors declare no competing interests.