Recruitment will take place across secondary care community mental health teams and service-user and carer groups within participating NHS Trusts. Clinical Studies Officers (CSO) will assist the Trial Manager and Research Assistants with identification, approaching, informing and recruiting patients into the study. To aid retention, the research team will provide regular updates to the participant in the time between their initial recruitment to the study and the start of the groups.
Those with delegated roles for informed consent are the Trial Manager, Research Assistants and CSOs. The Chief Investigator retains overall responsibility for the informed consent of participants and will ensure that all those with delegated responsibility are authorised, trained and competent to participate according to the protocol, principles of Good Clinical Practice (GCP) and Declaration of Helsinki [
27].
Participant identification
Clinicians and CSOs will screen the caseload of clinical teams to identify potentially eligible participants via medical records and review against the eligibility criteria. Those deemed potentially eligible will be contacted by a member of the clinical team either (a) during attendance of routine appointments where they are provided with a handout for potential participants or (b) via telephone or letter contact. The clinician will provide them with information about the study and obtain assent to be contacted by a member of the research team. Those who assent will have their information passed on to researchers/CSOs. The researcher will then make contact using the patient’s preferred contact method.
The researcher will go through the information sheet and answer any questions or concerns raised. If the patient is interested in participating, the researcher will then confirm contact details and arrange to meet to obtain informed consent, complete eligibility screening and, if eligible, baseline measures.
Patients linked to service-user and carer involvement groups across NHS Trusts will also be made aware of the study through the attendance of a researcher at their local meetings, who will provide information as outlined above. Any patients interested in the study will be provided with an information sheet or handout for potential participants which contains contact details of the local study team. If interested patients are ineligible, the researcher will thank them for their interest and advise them to contact their healthcare professional for further signposting to arts therapies and group therapies within the NHS Trust.
Meeting to take informed consent, eligibility check and complete baseline measures
All patients who express interest will be invited by phone or letter to attend a face-to-face or online meeting with a researcher. Researchers will go through the information sheet and take time to answer further questions or concerns.
If face to face, informed consent will be taken after a minimum of 24 h after first discussing the study with the researcher. All participants will be asked to provide written informed consent by initialling, signing and dating an informed consent form prior to any data collection commencing. This includes consent to video-recording of therapy sessions. Participants will be free to withdraw at any time without giving reasons and without prejudicing any further treatment.
For remote meetings, participants will be emailed or posted the Patient Information Sheet and blank consent form and then contacted by the researcher. The researcher will confirm if the participant has received the documents and will fully inform them about the study. If the participant agrees to enrol, the researcher will take verbal consent by filling in a copy of the remote consent form, which includes a note that consent is taken verbally and that the participant can contact the research team if they wish to withdraw at any point. The researcher will clearly sign, date and note that consent was taken verbally. The researcher will post a copy of the signed consent form to the participant and file a copy. Where participants have access, the consent will take place over a video-based teleconference system. The participant will initial and sign the form electronically. The signed form will be emailed to the researcher and the researcher will email a copy of the completed consent to the participant.
Once informed consent has been given, patients will be invited to complete the Brief Symptom Inventory (GSI score > 1.65) to screen for current symptom severity. If the patient scores greater than 1.65, video clips of arts therapies will be shown and the participant will be asked to state their preference for one single modality. Further baseline measures are then completed. Should the patient not meet the inclusion criteria, this will be explained and they will be thanked for their time and interest, with recommendations to speak with their healthcare professional should they wish to access arts therapies or group therapist within their service.
Interventions
Explanation for the choice of comparators {6b}
We hypothesise that the main effect of specific arts forms in the arts therapies groups is to increase the appeal of attending such a group and to facilitate engagement through creative means when a group is offered. We are using person-centred group counselling as an active control for those effects that are outside of our model, i.e. the provision of groups, the attention from professional staff and fellow group members, and the possibility of group interactions and exchange of experiences without using arts forms.
Intervention description {11a}
Group arts therapy
Group arts therapy for the purposes of this trial comprises group art therapy, dance movement therapy and music therapy. All modalities are commonly provided within NHS mental health care. Through consultation with service users and arts therapists, we described the practice of the intervention in a manual and developed a 3-day training for therapists joining the trial [
28]. All groups will consist of an opening check-in and warm-up before proceeding to a more focused use of the arts materials, with spaces to reflect upon the experience. Space will be given at the end of the session to reflect on group themes. Discussions will end with a closing activity.
Regulation of arts therapies
The titles ‘Art therapist’, ‘Art Psychotherapist’ and ‘Music Therapist’ are protected in the UK with requirements that an approved post-graduate course is undertaken and that the person is registered with the Health and Care Professions Council (HCPC). Art and music therapists must meet the ongoing continuing professional development and regulatory requirements and are audited on a bi-annual basis. The art and music therapists in this study will be registered with the HCPC and adhere to their requirements at all times.
Dance movement therapists do not yet have statutory regulation. The professional Association for Dance Movement Psychotherapy (ADMP) is an organisational member of the Humanistic Integrative Psychotherapy College (HIPC) which is compliant with the United Kingdom Council for Psychotherapy (UKCP) standards and regulations for practice. UKCP as an umbrella organisation is compliant with the Professional Standards Authority (PSA). ADMP also maintains HCPC standards with the aim to finalise the registration process with this regulatory body.
Person-centred group counselling
Group counselling will be provided based on person-centred principles. Through consultation with patients and counsellors, we amended the arts therapies manual to briefly describe group counselling for the purposes of this study and developed a 2-day training for therapists joining the trial [
27]. All groups will consist of an opening welcome and introductions before proceeding to more informal discussions on topics raised by group members. Space will be given at the end of the session to have a closing activity to summarise discussions and say goodbye. The venue for these groups will be similar to those used in the arts therapy groups and, where possible, will make use of the same space. Group counselling sessions will specifically not make use of arts activities during the sessions.
Regulation of group counsellors
Group counsellors do not yet have statutory regulation. The British Association for Counselling and Psychotherapy (BACP) and UKCP both maintain standards and regulations for practice and are compliant with the PSA. Group counsellors will be recruited for the purposes of this study and will be required to have post-graduate person-centred counselling qualification, registration with BACP or UKCP alongside experience of providing group counselling in NHS secondary mental health services.
Therapy schedule
Both group arts therapy and counselling will be provided twice per week for 20 weeks with a maximum of 40 available sessions. Participants will be invited to meet individually with the therapists in the group space in the 2 weeks prior to the group commencing to discuss any concerns regarding the groups or answer any questions they may have. Each session will last between 60–90 min, comprising a 60-min focused treatment group with up to 15 min either side to afford social activity between group members arriving and leaving. Participants will be actively encouraged to attend, but are free to choose not to. Should a participant miss a scheduled session, the therapists will contact the participant to ascertain the reason for missing the session, check on their wellbeing and refer onto the clinician responsible if concerns are raised. After the final therapy group, participants will be offered an individual end of therapy meeting with the therapists to enable signposting and referral onto further services if needed.
If too few patients choose one form of arts therapy to form a group at one of the sites, or if too many study participants show poor attendance or drop out completely during treatment, we will aim to refer additional patients from outside the trial so that a critical mass of 4 or more patients is maintained in each group. To ensure a critical mass of group membership for the trial duration, if group attendance falls below 4 for 2 sessions, therapists will inform the Trial Manager and work with local services to refer additional non-trial participants into the group. New referrals must meet the inclusion criteria as defined for this study; this will be confirmed through the completion of screening measures. Additional referrals into the group will be accepted until week 10 of the intervention, after which point, the group will be closed to new referrals. Patients joining the group for this purpose will be provided with an information sheet about the study and written informed consent will be obtained for the purposes of audio-visual recording.
Criteria for discontinuing or modifying allocated interventions {11b}
Participants will be withdrawn from the intervention if the participant becomes too unwell to continue group participation either through:
-
Loss of capacity to consent to group attendance.
-
Level of risk assessed by the clinical team to require hospitalisation.
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Arts therapists/group counsellors and clinical team assess the current mental state, behaviour or risk to self or others that requires discontinuation of group attendance
It is always within the remit of the physician responsible for a patient to withdraw a patient from a trial for appropriate medical reasons, be they individual adverse events or new information gained about a treatment. If a participant chooses to withdraw from the intervention, they will be asked if they wish to continue to participate in the study and provide follow-up assessments or to withdraw from the study as a whole. Reasons for and date of withdrawal from the intervention or study as a whole will be recorded in the case report form. If a participant withdraws, we will not replace them within this study, but based on group timing and regular attendance, may open the group space to a non-trial participant to ensure a critical mass of group members is maintained. Should a participant recover or wish to recommence group therapy whilst the group is ongoing, the therapist will liaise with the clinician responsible for the participant’s care to ensure the person is ready and able to recommence. The date the intervention is recommenced will be recorded in the case report form.
Strategies to improve adherence to interventions and assessment of compliance {11c}
Based on a meta-analysis of music therapy for mental illness [
29] and Cochrane review of dance movement therapy for depression [
5], we would expect a medium effect after 20 sessions and a large effect after 40 sessions. We will take attendance of 20 sessions (50% of all available sessions) as a minimum for compliance. Compliance with the intervention will be assessed by the therapists providing the group therapy recording attendance and reasons for non-attendance on the attendance log. Late arrivals and early departures will be noted with the time and any reason for this. Should a participant miss a session, the therapists will contact them (as outlined above). Persistent noncompliance will not lead to withdrawal from the study unless requested by the participant. Measures to improve compliance will consist of:
-
Meeting the therapist individually at the group location in the week prior to the intervention to set expectations and explain the intervention.
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Written reminder of the group schedule and telephone call the day prior to the group to remind the group is commencing.
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Telephone call reminders offered to participants for the duration of the study.
-
Telephone call follow-up by the therapist when a session is missed.
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Buddy system of travel where participants support each other to travel to sessions together.
Relevant concomitant care permitted or prohibited during the trial {11d}
Participants will continue with concomitant medication and any other therapies as usual. If concerns are raised regarding the burden or interaction effects of attending both trial intervention and a talking therapy, the participant will be advised to speak with their clinician to ascertain whether or not to continue in the study.
Provisions for post-trial care {30}
This trial will adhere to the Declaration of Helsinki 2013 with respect to provisions for post-trial access for all participants who still need an intervention identified as beneficial in this trial. Clinical need and signposting to existing services have been incorporated into the treatment manuals for this trial. Participants will be offered the opportunity to meet with therapists once after the group has finished to discuss the remaining needs and services which they may wish to be referred into. Referrals will be made in conjunction with the participants’ existing care team. Any participants wishing to continue group arts therapy will be referred to existing groups within NHS community teams or offered within local charitable organisations (e.g. MIND). The study team is well integrated within the local NHS Trust care systems and will liaise on an ongoing basis with participants’ care teams in relation to any important information required by or important to care staff.
Outcomes {12}
Primary and secondary outcomes {12a}
Quantitative outcomes will be collected at baseline, within 4 weeks of the end of the intervention (post-intervention) and 6 and 12 months post-intervention ending. The primary outcome will be psychological distress at end of treatment (20 weeks), measured using the Brief Symptom Inventory global severity index (GSI) [
26]. Our secondary outcomes are as follows: Brief Symptom Inventory (BSI) subscales: Somatisation, Obsessive compulsive, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, Psychoticism and Positive Symptom Distress Index; observer-rated psychiatric symptom severity on the Brief Psychiatric Rating Scale (BPRS) [
30]; quality of Life on the Manchester Short Assessment of Quality of Life Scale (MANSA) [
31]; and objective Social Situation (SIX) [
32].
Treatment fidelity {12b}
We will take both therapist and observer ratings of adherence to the manual. Therapist self-rated adherence to the manual will be rated by therapists at the end of each session on an adherence form designed for the purposes of this study. Observer ratings of treatment fidelity will be made from videos of 10% of therapy sessions, selected at random and rated on the adherence form designed for the purposes of this study.
Process evaluation {12c}
A process evaluation will consider the following data and measures including, attendance of therapy sessions and reasons for nonattendance over the 20-week intervention period. Patient-reported appraisal of the sessions in weeks 2, 7, 12 and 17 of the intervention period on the Outcome Rating Scale (ORS) [
33]. Self-reported depression in weeks 2, 7, 12 and 17 of the intervention period on the Personal Health Questionnaire (PHQ-9) [
34]. Group experiences in weeks 2, 7, 12 and 17 of the intervention period on the Ferrara Group Experiences Scale (FGES) [
35]. Qualitative end of therapy interviews with a purposive selection of 13% of participants and therapists using the Client Change Interview [
36].
Economic evaluation
Economic evaluation will include the following measures at baseline, post-intervention, 6 months and 12 months post-intervention: quality of life for trial participants on the EQ-5D-5L [
37], Recovering Quality Of Life (ReQoL-20) [
38]; use of health and social care services on the Client Services Receipt Inventory (CSRI) [
39]; and costs estimation of group arts therapies (art therapy, dance movement therapy and music therapy) and group counselling using inventory forms designed by the trial Health Economist.
Sample size {14}
We have designed the trial to detect a treatment effect of 0.5 standard deviations on the primary health outcome, i.e. the level of psychological distress, as measured by the Brief Symptom Inventory Global Severity Index. In a sample of 378 patients from a UK psychiatric outpatient population, the mean GSI was 1.65 with a standard deviation of 0.81 [
40]. An effect of 0.5 standard deviations would therefore represent a difference of 0.4 on the GSI. We assume clustering of outcomes of patients treated in the same therapy group. In the NESS trial on group body psychotherapy [
10], the ICC for therapy groups of 10 patients varied for different outcomes, but did not exceed 0.01 (which applied to the primary outcome). We assumed, conservatively, an ICC of 0.1. We assume a drop-out rate of 15% by the end of the study, so that if we allocate 10 patients on average to each therapy group we will end up with clusters with 8.5 patients on average. Assuming a coefficient of variation of cluster size of 0.5, we will need 200 patients before drop-out in 20 clusters in each arm to achieve 90% power at the 5% significance level [
41]. Allowing, conservatively, for the additional loss of one full cluster in each arm, we plan to recruit a total of 2 × 210 patients.
The estimated loss takes into account drop-outs at each of the different phases of the study, i.e. between consent and beginning treatment, during treatment, during the 6-month follow-up period and during the 12-month follow-up period. Some patients will have to wait between giving consent and beginning of treatment. Within this period, they may drop out due to changing their mind, being offered alternative treatment or experiencing a reduction in symptoms. Based on previous studies [
9,
10], we expect this drop-out rate to be less than 10% and we will be able to compensate for most of that loss through recruiting additional patients closely before the time of the baseline assessment.
During the treatment phase, we may have drop-outs from both groups. An intention-to-treat approach to analysis does not mean that all outcome data must have been collected, but it does mean that every effort should be made to minimise the amount of missing data. We expect a low drop-out rate from research during treatment but envisage a drop-out rate of 10% by the 6-month follow-up (in NESS [
10] it was 7.3% after 6 months), and 15% by the 12-month follow-up.