A trial will test whether a brief, therapist-led behavioural activation programme delivered partly online can lift severe depression in 528 adolescents aged 11 to 17 who are waiting for specialist NHS mental health care. Only one in four young people with mental health disorders currently receives any help. Specialist Child and Adolescent Mental Health Services (CAMHS) have long waiting lists and staff shortages, and the pandemic pushed much therapy online without clear evidence that remote or blended approaches work for severe depression. This trial directly compares a blended behavioural activation (BA) programme—eight sessions using workbooks and a website, delivered by clinicians without specialist therapy training—against standard care plus psychoeducation. If the BA programme proves effective and cost-effective, it could give thousands of severely depressed teenagers faster access to a proven therapy without requiring highly specialised therapists. The NHS could reduce waiting times and treatment costs while expanding the skills of its existing CAMHS workforce. The trial will also produce practical recommendations on how to deliver blended therapy in routine NHS settings, a question that now affects every mental health service.
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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. 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. Objectives: 1. Co-design our website with YP; train therapists. 2. Conduct internal pilot to assess recruitment and acceptability; progression criteria to full trial. 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). 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). 5. Examine immediate and longer-term acceptability, barriers to uptake and engagement from multiple stakeholder perspectives. 6. Develop recommendations for depression treatment in CAMHS, including blended delivery approaches. Methods Design: randomised controlled trial of blended BA+TAU versus TAU+PE with internal pilot and qualitative study Setting: specialist CAMHS clinics in 4 English NHS trusts Population: adolescents aged 11-17 with low mood on initial assessment (MFQ-C, 27 or more) Measurement of Costs and Outcomes: Primary outcome: MFQ-C at 12 weeks 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. 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. Health Technologies assessed: ‘Be Active’ workbooks (8 sessions) with blended delivery + TAU versus TAU+psychoeducation. 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. Timelines: 45 months duration Months 1-9: protocol development; REC and R&D approvals; staff recruitment; database and website development; training. Month 10-17: Internal pilot. Recruit 5-6 participants/month/site (n176, 8 months); pre-determined Stop/Go progression criteria. Month 16 to 33. Main trial. Recruit further 352 participants (5.5 participants/month/site; total 528). Month 34 to 39. Completion of follow ups, fidelity ratings and qualitative interviews. Month 40 to 45. Data analysis, monograph submission and dissemination. 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.
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