Title: BAY: Behavioural Activation for Young people with depression in specialist child and adolescent mental health services
Funder: Department of Health and Social Care

Abstract: Introduction: In 2017, nearly one in 4 teenage girls and one in 10 boys in the UK reported high levels of depressive symptoms. Since then, emotional problems have been increasing in young people (YP) and now the covid-19 pandemic is seriously affecting their lives. Even before covid-19, 3/4s of YP with the highest levels of mental health problems could not get help in specialist Child and Adolescent Mental Health Services (CAMHS). Even when they do, many YP with high levels of depression wait months for specialist therapy. These therapies are expensive and need highly trained staff but there are not enough therapists. _x000D_ _x000D_ Depressed YP struggle to do everyday things. Behavioural Activation (BA) is a treatment which may help, through planning and doing more things that matter to the YP (activities they value), like hobbies and keeping in touch with people. BA works well for adults and less experienced therapists can offer it. We don’t have enough proof that BA works as well for YP, but small studies suggest that it may be helpful._x000D_ _x000D_ We have developed a BA workbook called “Be Active” with YP and carers and tested it in 2 small studies in CAMHS. YP liked the therapy and almost half did not need further treatment; YP also told us that they think our study question is an important one._x000D_ We need to test whether BA really works in a large study where there is a 50:50 chance of receiving BA. Training in BA is easier and quicker than other therapies, and staff who don’t have therapy training, like newly qualified nurses and assistant psychologists, can provide BA. YP could be offered BA whilst they are waiting for more specialist therapy rather than just getting ‘routine care’ (e.g. check-ins)._x000D_ _x000D_ Aims: Since the covid-19 pandemic, services have been working with YP in a mixed way, seeing them in clinics, and over the phone or video ('blended' therapy). We know that YP like to choose how they talk to their therapist when possible. Our study showed that BA could work with a therapist over the phone or video and using Be-Active on our website. _x000D_ The trial would ask:_x000D_ 1) If adding blended BA to routine care works better than ‘usual routine care plus information about depression’, whilst YP wait for specialist therapy _x000D_ 2) What YP, carers and clinicians think about blended BA _x000D_ 3) Does blended BA provide value for money?_x000D_ _x000D_ We will ask other questions, for example, if YP still need more therapy after BA. We will include a test period to make sure enough people want to take part. We will develop our website with YP before we start, as YP told us that they liked seeing our workbook on the website but we needed to make it better._x000D_ _x000D_ Method: We will involve 528 11-17-year-old YP with depression in 4 areas of England. The YP will be divided by chance into 2 groups. One group will get blended BA and routine care; the other, routine care plus information on depression. We will only leave out a few YP, like those needing urgent care. We will train less experienced clinicians, and hope (if covid-19 guidelines allow) to offer the first, and a few more, sessions face to face. This helps develop a good relationship between a therapist and YP and helps the therapist to monitor risks. The other sessions will be planned together, including options of video or phone call. We will offer 8 sessions of 50 minutes, and agree with the YP when to include carers._x000D_ _x000D_ Analysis and Outputs: Researchers will collect a range of information from YP, carers and clinicians. YP and carers will help us plan the study and inform people about the findings, through social media, publications, events and conferences

Lay abstract: Background: Depression rates in young people (YP) are increasing, and may increase further with the covid-19 pandemic, but only 25% of children and YP with mental health disorders receive help. The government Green Paper offers mental health support in schools for mild problems; YP with more severe depression are seen in specialist CAMHS where there are staff shortages and long waits for therapy. Delivery modes changed with Covid-19 with remote working and blended therapy. We developed a behavioural activation (BA) intervention with a brief training to clinicians without specialist therapy skills to deliver blended BA. _x000D_ Aims and objectives: examine effectiveness, cost-effectiveness and acceptability of blended BA + treatment as usual (TAU) versus TAU + psychoeducation (PE) in depressed adolescents in specialist CAMHS. _x000D_ Objectives:_x000D_ 1. Co-design our website with YP; train therapists._x000D_ 2. Conduct internal pilot to assess recruitment and acceptability; progression criteria to full trial. _x000D_ 3. Determine clinical effectiveness of blended BA+TAU versus TAU+PE at 12 weeks (primary outcome, self-rated child Mood and Feelings Questionnaire, MFQ-C) and 6 months post-randomisation, and at 1 year follow up (naturalistic sub-group)._x000D_ 4. Determine cost effectiveness of blended BA+TAU versus TAU+PE at 12 weeks, 6 months (primary outcome) and 1 year follow up (naturalistic sub-group)._x000D_ 5. Examine immediate and longer-term acceptability, barriers to uptake and engagement from multiple stakeholder perspectives._x000D_ 6. Develop recommendations for depression treatment in CAMHS, including blended delivery approaches._x000D_ Methods_x000D_ Design: randomised controlled trial of blended BA+TAU versus TAU+PE with internal pilot and qualitative study_x000D_ Setting: specialist CAMHS clinics in 4 English NHS trusts_x000D_ Population: adolescents aged 11-17 with low mood on initial assessment (MFQ-C, 27 or more)_x000D_ Measurement of Costs and Outcomes: _x000D_ Primary outcome: MFQ-C at 12 weeks_x000D_ Secondary outcomes: Numbers discharged; clinically relevant measures of mood, anxiety, behavioural problems, impairment, and quality of life; website use; qualitative analysis involving YP, carers and clinicians._x000D_ Costs: economic analysis primarily from an NHS and social care perspective at each time point; primary analysis at 6 months. A decision model will be constructed to explore costs and benefits for a naturalistic subgroup at 1 year (n 396), informed by trial data and literature._x000D_ Health Technologies assessed: ‘Be Active’ workbooks (8 sessions) with blended delivery + TAU versus TAU+psychoeducation._x000D_ Sample Size: 448 participants required for 90% power to detect an effect size (ES) of 0.3125. ES corresponds to a minimally important difference of 5 points on MFQ-C (standard deviation 15). Conservatively inflating the sample by 15% for attrition requires 528 participants. _x000D_ Timelines: 45 months duration_x000D_ Months 1-9: protocol development; REC and R&D approvals; staff recruitment; database and website development; training._x000D_ Month 10-17: Internal pilot. Recruit 5-6 participants/month/site (n176, 8 months); pre-determined Stop/Go progression criteria. _x000D_ Month 16 to 33. Main trial. Recruit further 352 participants (5.5 participants/month/site; total 528). _x000D_ Month 34 to 39. Completion of follow ups, fidelity ratings and qualitative interviews. _x000D_ Month 40 to 45. Data analysis, monograph submission and dissemination._x000D_ Impact: benefits to YP with timely access to therapy; increased clinician skills; NHS service delivery and potential cost savings. Dissemination: NHS events, conferences, training resources, publication, mainstream/social media and website.

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