Primary Care Online Emotion-regulation Treatment (POET) — POET  

Mental Health Issue Clinical Trial

Official title: Primary Care Online Emotion-regulation Treatment (POET)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Mental Health Issue

• NCT number: NCT06067165
• Study type: Interventional
• Source: Karolinska Institutet
• Contact: Johan Bjureberg, PhD
• Phone: +460852480000
• Email: johan.bjureberg@ki.se
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Completion date: November 25, 2031