Primary Care Online Emotion-regulation Treatment (POET)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2031-11-25

Brief Summary

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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.

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Detailed Description

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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

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Mental Health Issue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Assessors conducting post- and follow-up assessments will be blind to treatment allocation, for the full duration of the trial. The outcome measures are identical for both groups, ensuring that the assessors remain blind. To ensure blinding integrity, participants receive explicit instructions not to disclose which treatment participants have received. After completing the assessment, the blind raters guess the participant's group allocation and disclose the reason for their guess and record whether the participants has inadvertently revealed their group allocation. Blind assessments will be recorded to allow for calculation of inter-rater reliability.

Study Groups

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POET feeling

POET will include six guided digital treatment modules for the youth, and six modules for the parents administered over the course of six weeks.

Group Type EXPERIMENTAL

POET feeling

Intervention Type BEHAVIORAL

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.

Supportive treatment

The active control will be supportive treatment. It includes six guided digital treatment modules for the youth, and six modules for the parents administered over the course of six weeks.

Group Type ACTIVE_COMPARATOR

Supportive treatment

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age between 12 - 17 years
* Seeking care for mental health problems
* At least one guardian interested in participating in the parent program
* Deemed capable of making decisions

Exclusion Criteria

* Psychiatric problems that require more extensive treatment.
* Low global functioning (under 41 points on clinician rated C-GAS or functioning that requires more extensive treatment).
* Elevated suicide risk
* Insufficient Swedish comprehension.
* Life circumstances that complicate or make treatment impossible (eg severe deficits in parental care, domestic violence).
* Change in psychopharmacological medication in the last 2 months.
* Ongoing psychological treatment

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No