A feasibility Randomised Controlled Trial (RCT) of an evidence-based creative group psychotherapy for adults with symptoms of depression (Arts for the Blues) in National Health Service (NHS) Talking Therapies compared to treatment as usual
Specialty: Mental Health, Primary sub-specialty: Depression; Health Category: Mental health; Disease/Condition: Mood [affective] disorders
Trial design The study will involve a randomised controlled feasibility trial with two parallel groups. Sixty participants will be randomised at a ratio of 1:1 to either 12 sessions A4B (active arm) or Treatment as Usual (TAU) (control arm). Potential participants will be assessed for suitability for A4B using inclusion/ exclusion criteria. Outcomes will be collected at clinical assessment/ baseline, 12 weeks and 24 weeks post baseline. The researcher undertaking randomisation will not be blinded to treatment allocation. Therapists will be blinded to treatment allocation at the assessment stage but not at the treatment stage. Participants will be randomly allocated to either A4B or TAU using an independent web-based randomised procedure (www.sealedenvelope.com) after baseline assessment. The trial framework is exploratory, assessing whether a future definitive trial is possible and how it should be designed. Trial settings Participants will be recruited via stepped-care primary care mental health services in the Greater Manchester Mental Health NHS Foundation Trust (GMMH), including NHS services such as Talking Therapies (Step 3 and Step 3 plus) and community partner agencies such as Six Degrees in Salford, 1 Point in Bolton (Step 2 and Step 3). Clinical assessments will be in person, on the phone or online on Microsoft Teams in line with the Trust's policies for remote consultations. Recruitment The study will be based in Greater Manchester Mental Health NHS Foundation Trust (GMMH) and partner organisations covering Greater Manchester, including the boroughs of Manchester, Trafford, Salford, Bolton and Wigan. People will be able to access the study in the borough where they are registered with a GP. The research will be advertised externally on social media (e.g. Facebook, LinkedIn, WhatsApp groups etc) and websites (e.g. GMMH or University of Salford website etc). People who are interested in the study will be able to self-refer via the usual self-referral link
1. Must be registered with a GP in Greater Manchester 2. Must be 18 years old or older 3. Must have/had depression or symptoms of depression (assessed by PHQ9 > 5) 4. Is interested in taking part in group work 5. Is interested in taking part in the creative interventions. 6. Must be able to communicate in English 7. Willing to be randomised to A4B or TAU
1. Receiving concurrent active psychological therapy, including structured psychological therapies such as CBT, EMDR or counselling. Other forms of support, such as support groups, skills groups, seeing a clinician for informal support or medication advice, or engaging in self-help materials, will not be an exclusion criterion 2. Participating in another current clinical trial involving psychological therapy 3. Currently at high (imminent or immediate) risk of harming self and others (determined by the presence of suicidal intent and/or plan and marked as ‘current’ and ‘high’ in related sections of MINI neuropsychiatric interview (Sheehan, 1998)) 4. Current alcohol or substance use disorder (determined by a ‘severe’ score in related sections of the MINI neuropsychiatric interview (Sheehan, 1998)) 5. Those who are psychologically or physically too unwell to attend the group or/ and are presenting with any condition which would make participation in the group difficult, such as current, active episode of psychosis or mania or have symptoms associated with personality disorder (determined by related sections of MINI neuropsychiatric interview (Sheehan, 1998), Zanarini BPD Scale (Zanarini, 2003) and/or existing diagnosis). History of the above difficulties will not be an exclusion criterion, if clients don’t have current symptoms