Primary Care Online Emotion-regulation Treatment (POET)

Introduction:

Mental health problems among young people are prevalent and many youth in need of treatment for mental health problems do not meet criteria for any mental health disorder or they meet criteria for several disorders. Most existing treatments focus on a subset of mental disorders and do not address subthreshold or multi-disorder mental health problems. In addition, available treatments do not typically target transdiagnostic disease mechanisms. Furthermore, the available treatments are limited in efficacy and most youth in need do not receive treatment due to social stigma and structural barriers such as geographical distance to treatment providers.

The aim of this randomized clinical trial is to determine the clinical efficacy of a digital emotion regulation treatment in adolescents with mental health problems. Participants will be randomized to a digital emotion regulation treatment or to an active comparator. Treatments in both conditions will include therapist support, and will be delivered in a blended treatment format combining asynchronous therapist-guided online modules with one synchronous session delivered over video-link. The primary endpoint is at post- treatment.

Primary objectives:

1. To test the effects of POET on mental health problems. 2. To test the effects of POET on emotion regulation.

Secondary objectives:

1. To test if emotion regulation mediates reductions in mental health problems during treatment. 2. To test if POET is cost-effective. 3. To test if POET works better for some individuals than others (i.e., moderation). 4. To test if there are detectable differences in distal outcomes between POET and active control 12 to 60 months post treatment and if individual baseline characteristics moderates these effects.

Research questions:

1. What are the effects of POET on mental health problems? 2. What are the effects of POET on emotion regulation? 3. Are reductions in mental health problems during the POET treatment mediated through emotion regulation? 4. Is POET feeling cost-effective? 5. Does POET work better for some individuals than others? 6. Are there detectable differences in distal outcomes between POET and active control 12 to 60 months post treatment and if individual baseline characteristics moderates these effects

• The Clinical Global Impressions - Improvement scales (CGI-I) [Срок оценки: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended]
• The Revised Child Anxiety and Depression Scale-C (RCADS-C) [Срок оценки: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended]
• The Revised Child Anxiety and Depression Scale-P (RCADS-P) [Срок оценки: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended]
• Brief 11-item version of the Revised Child Anxiety and Depression Scale for Adolescents (RCADS-11) [Срок оценки: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended]
• Children's global assessment scale (CGAS) [Срок оценки: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended]
• The Work and Social Adjustment Scale (WSAS) [Срок оценки: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended]
• The Positive and Negative Affect Schedule for Children (PANAS-C) [Срок оценки: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended]
• The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) [Срок оценки: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended]
• Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) [Срок оценки: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended]
• The Process Model of Emotion Regulation Questionnaire -short (PMERQ-S) [Срок оценки: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended]
• The Perth Alexithymia Questionnaire-Short Form (PAQ-S) [Срок оценки: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended]
• Self-Efficacy Questionnaire for Children (SEQ-C) [Срок оценки: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended]