Title: Effectiveness of group arts therapy for diagnostically heterogeneous patients: Randomised controlled trial in mental health services (ERA)
Funder: Department of Health and Social Care

Abstract: Design: Two-arm, single-blinded, multi-site, pragmatic randomised controlled trial, with internal pilot. Setting: Secondary mental health out-patient services. Target population:Patients with different mental disorders in mental health services. Inclusion: Outpatient in secondary mental health care;motivation to attend group arts therapy for 5 months and expression of preference for one of the three forms;18+ years of age;primary diagnosis of ICD-10[1] F2 (schizophrenia and related psychotic disorders), F3 (mood disorders), F4 (anxiety and other non-psychotic disorders);at least moderate symptom level on BSI[2]; Exclusion: Primary diagnosis of organic, substance misuse or personality disorder;duration of current mental disorder <6 months (i.e. patients with short-term crises);physical condition that prevents attendance of groups;insufficient command of English for communication. Health technologies being assessed: Group arts therapies (art therapy, music therapy, dance-movement therapy), as compared to group counselling as an active control, both provided in 40 sessions over a 5 month period. Measurement of costs and outcomes: Costs of group arts therapies and the control condition will be documented by the study team; costs of other care will be calculated based on electronic medical records; Patient self-ratings and observer ratings will be obtained in interviews with blinded research assistants at baseline, end of treatment, 6 and 12 months post-intervention; ratings include symptoms on the Brief Symptom Inventory[2] and quality of life on the Manchester Short Assessment of Quality of Life[3] Sample size: 167 in 20 clusters in each arm, assuming an ICC of 0.01 and a co-efficient for variation of cluster size of 0.5, to detect an effect size of 0.5 on a 5% significance level with 90% power. Allowing for 15% drop out, we will require 2 x 197 patients. Allowing for the additional loss of one cluster (treatment group) in each arm, we will need to recruit 210 patients in each arm, i.e. a total of 420 patients. Difference between current and planned care pathways: Group arts therapies are already provided in some services in the NHS. Yet, provision is highly inconsistent, not evidence-based and rarely considers patient preferences. Project timetables including recruitment rate: Pre-study: All approvals Month 1-2: Trial set up and preparation Month 3-8: Recruitment of 180 patients for first groups in internal pilot across 3 sites, site recruitment rate 10 per month Month 9-13: Group therapies in internal pilot Month 10: Decision about moving to full trial Month 11-16: Recruitment of 240 patients in full trial across 3 sites, Recruitment rate 10 per month (Avon, Luton); 20 per month (London) Months 17-21: Group therapies in intervention and control arms in full trial Months 13-28: 6 month follow-ups (internal pilot and full trial), qualitative interviews Months 25-34: 12 month follow-ups (internal pilot and full trial) Months 34-39: Analysis, report writing and dissemination Study duration: 39 months Expertise in team: The team includes expertise in developing and evaluating complex interventions (Priebe, Carr), managing large multi-site trials in arts therapies (Priebe, Crawford), music therapy (Carr, Sandford), art therapy (Huet, Havsteen-Franklin), dance-movement therapy (Karkou, Feldtkeller), personal experience of arts therapies (Smith), bio-statistics (Hooper) and health economics (Mihaylova)

Lay abstract: Aim: We want to test if arts therapies groups are effective for patients with different types of mental illness. Background: Arts therapies use different art forms and creative activities to help people living with mental illness. These include music therapy, dance-movement therapy and art therapy. Each has a different focus: on the ‘ear’ (music), the ‘body’ (dance-movement) and the ‘eye’ (art). They are usually provided in regular group meetings over a few months. Arts therapies may help patients to express emotions and have experiences which might not be possible in talking therapies. Different people prefer different art-forms. If patients can choose which art-form they like best, they may be more likely to attend and benefit from this. While arts therapies are popular with many patients, they are not always provided in NHS services. So far, there has been little research to show that they are helpful. Existing research has involved people with only one diagnosis (such as schizophrenia). This is different to how arts therapies groups are provided as they usually include people with different mental illnesses. Design and methods used: We will ask patients in community mental health services if they would like to participate in a form of group arts therapies and, if so, which one. They will then be divided in two groups by chance. Half will receive their preferred form of arts therapy group. The other half will be offered group meetings with general talking and support, but no use of arts. Patients can attend for up to 40 sessions over 5 months. We will interview patients at the beginning and end of treatment, 6 and 12 months later. We will then compare the two groups to see if patients receiving arts therapies had a better improvement of symptoms and quality of life. PPI: Patients who took part in our previous studies told us that it was important that they could access the art-form they preferred. They also suggested that future research included more than one art form. We will include music, visual art and dance and ask patients which one they prefer. This means that patients have a choice and can access their preferred art form. We discussed our ideas for this study with the Service User and Carer Advisory Group on Research (SUGAR). The group recommended that we: -use video clips to explain what arts therapies are to patients and referring clinicians -ask patients if they enjoyed the sessions and experienced support from other group members -include views from clinicians in charge of the patient’s care. We have included all of these suggestions. We will continue to ask SUGAR for advice on how to provide information to patients and how to share our findings. We will attend their meetings regularly to share our progress and challenges. One of the co-applicants is a service user who has attended different arts therapies groups. She will be a full member of the research team and help to coordinate a lived experience advisory panel (LEAP). We will also ask the funder to include a user representative on the Steering Group for the Trial. Dissemination: We will share our findings based on advice from our service user co-applicant, SUGAR and the professional organisations of the different arts therapies. We will have a website with information about the arts therapies and the trial. We will present the study idea, protocol and findings at conferences and professional meetings, and publish in open access journals.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH