Randomised superiority trial evaluating an online transdiagnostic emotion regulation treatment for adolescents with mental health conditions: study protocol.

Mental health conditions are prevalent during adolescence, but access to early evidence-based treatments remains limited. Scalable, online, theory-based transdiagnostic interventions delivered in primary care have the potential to reduce this treatment gap, but the effectiveness remains unknown. The objective is to investigate whether an online transdiagnostic emotion regulation treatment for adolescents with mental health conditions is superior to an active control treatment.

This single-blind, randomised clinical superiority trial will evaluate the effectiveness and cost-effectiveness of an online transdiagnostic emotion regulation treatment for adolescents with mental health conditions within primary care in Sweden. We aim to include 388 participants (adolescents aged 12-17 years with mental health conditions and their parents), recruited through primary care and self-referral. Patients will be randomised to either an online transdiagnostic emotion regulation treatment or an active control treatment. Participants will receive 6 weeks of therapist-guided online transdiagnostic emotion regulation treatment or an active control treatment consisting of 6 weeks of online supportive treatment. Parents will participate in parallel with their adolescents in both conditions and will receive an online parent course. The primary outcome, assessed by blinded assessors, will be clinical global symptom severity measured with the Clinical Global Impressions-Severity scale. Treatment effectiveness will be evaluated through blinded assessment and self-assessment at primary endpoint (immediately after treatment) and 3 months after treatment. In addition, a health economic evaluation will be conducted. The study will be undertaken between October 2023 and July 2026.

The study has obtained ethical approval from the Swedish Ethical Review Authority. Findings will be disseminated in peer-reviewed publications and presented at scientific conferences.

NCT06067165.
Mental Health
Access
Care/Management
Policy
Advocacy

Authors

Sjöblom Sjöblom, Bellander Bellander, Nilbrink Nilbrink, Zetterqvist Zetterqvist, Sampaio Sampaio, Hedman-Lagerlöf Hedman-Lagerlöf, Hellner Hellner, Gross Gross, Hesser Hesser, Bjureberg Bjureberg
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