NCT06067165

Primary Care Online Emotion-regulation Treatment (POET)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 388 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Mental health problems in youth are a global problem, causing incalculable suffering in youth and families, harming long-term prospects of youths, and creating substantial economic costs to society. The overall objective of this study is to build an evidence base for a highly scalable transdiagnostic intervention called the Primary care Online Emotion-regulation Treatment (POET) for youth (12-17 years) seeking treatment for mental health problems. In a randomized controlled trial, the investigators will examine the effects of POET. The investigators will test if emotion regulation mediates reduction in mental health problems during treatment. In addition the investigators will test if POET is more effective for some individuals than others and evaluate if POET is cost-effective. The investigators will also test whether there are detectable effects of POET on distal outcomes utilizing registry data following participants up to 10 years post treatment.

Detailed description

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

Conditions

• Mental Health Issue

Interventions

Type	Name	Description
BEHAVIORAL	POET feeling	POET is adapted from online Emotion Regulation Individual Therapy for Adolescents developed by the research group (ClinicalTrials.gov Identifier: NCT03353961). POET is also based on the Modal model of emotion and Process model of emotion regulation that provides a framework for understanding how emotions are generated, experienced and how they can be regulated. The youth component of POET will include psychoeducation, addressing maladaptive beliefs about emotions and emotion regulation, and teaching adaptive emotion regulation strategies, such as acceptance of emotions and flexible cognitive reappraisal. The parent component will include psychoeducation and teaching effective support and responding to their adolescent's and their own emotions.
BEHAVIORAL	Supportive treatment	The treatment will include educative material on mental health and self-reflection on themes such as school, family and friends. The parent component will include educative material and self reflection in how to support their adolescent.

Timeline

• Start date: 2023-10-16
• Primary completion: 2026-10-01
• Completion: 2031-11-25
• First posted: 2023-10-04
• Last updated: 2025-09-22

Locations

1 site across 1 country: Sweden