Trials · 2026
A study protocol for a randomised controlled trial investigating the clinical effectiveness, cost effectiveness and acceptability of Behavioural Activation for Young people (BAY) in CAMHS settings.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Standley Emma, Ellison Rachel, Bee Penny, Bhardwaj Anupam, Blackwell Jane, Carter Lesley-Anne, Yilmaz Gokce Cokamay, Cowling Abbie, Elvins Rachel, Hewitt Catherine, Hull Paula, Marwedel Susanne, McCulloch Amy, Mitchell Alex, Piccolo-Lawrance Camila, Sayal Kapil, Strange Hannah, Street Melissa, Wakefield Emma, Wakefield Toni, Wallis Paul, Wang Han-I, Whelan Pauline, White Clare, Young Sam, Dubicka Bernadka
Аннотация
BACKGROUND: Emotional disorders in young people have been increasing, leading to a high demand for support and long waiting times for UK child and adolescent mental health services (CAMHS). Consequently, access to evidence-based psychological therapy is limited; in addition, many young people do not respond to existing treatments. Blended delivery of therapy, which combines face-to-face and digital interventions, offers a promising solution to improve the reach and effectiveness of mental health support. However, the efficacy of blended behavioural activation (BA) for young people with depression is not yet established.
METHODS: This randomised controlled trial will investigate the clinical and cost effectiveness of blended behavioural activation intervention for adolescents aged 11-17 years with moderate to severe depression. We will recruit 446 participants from CAMHS across 6 sites in the UK. Participants will be randomised to receive either BA with psychoeducation (PE) and treatment as usual (TAU) or PE and TAU. The primary outcome measure will be depressive symptoms, assessed using the child-completed Mood and Feelings Questionnaire (MFQ-C) at 6 months. A range of secondary outcome measures will be collected to estimate the clinical and cost effectiveness and acceptability of the intervention. A nested qualitative investigation exploring provider and young people/carer perspectives will be included.
DISCUSSION: The findings from this trial will provide crucial evidence on the effectiveness of blended BA for young people with moderate to severe depression. If effective, this intervention could offer a scalable and accessible treatment option, potentially transforming the delivery of mental health services for adolescents. The large sample size and pragmatic approach will enhance the generalisability of the results, informing future clinical practice and policy.
TRIAL REGISTRATION: ISCRTN12315118. Registered on August 29, 2023.
METHODS: This randomised controlled trial will investigate the clinical and cost effectiveness of blended behavioural activation intervention for adolescents aged 11-17 years with moderate to severe depression. We will recruit 446 participants from CAMHS across 6 sites in the UK. Participants will be randomised to receive either BA with psychoeducation (PE) and treatment as usual (TAU) or PE and TAU. The primary outcome measure will be depressive symptoms, assessed using the child-completed Mood and Feelings Questionnaire (MFQ-C) at 6 months. A range of secondary outcome measures will be collected to estimate the clinical and cost effectiveness and acceptability of the intervention. A nested qualitative investigation exploring provider and young people/carer perspectives will be included.
DISCUSSION: The findings from this trial will provide crucial evidence on the effectiveness of blended BA for young people with moderate to severe depression. If effective, this intervention could offer a scalable and accessible treatment option, potentially transforming the delivery of mental health services for adolescents. The large sample size and pragmatic approach will enhance the generalisability of the results, informing future clinical practice and policy.
TRIAL REGISTRATION: ISCRTN12315118. Registered on August 29, 2023.
Предметные рубрики MeSH
AdolescentChildFemaleHumansMaleAdolescent BehaviorAdolescent Health ServicesBehavior TherapyChild BehaviorCost-Benefit AnalysisCost-Effectiveness AnalysisDepressionHealth Care CostsMental Health ServicesMental Health TeletherapyMulticenter Studies as TopicPatient Acceptance of Health CareRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeUnited Kingdom