Primary Care Online Emotion-regulation Treatment (POET)

Karolinska Institute

Status: Enrolling

Conditions: Mental Health Issue

Treatments: Behavioral: Supportive treatment; Behavioral: POET feeling

Study type: Interventional

Funder types: Other

Identifiers

NCT06067165

2023-03652-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 388 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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388 participants in 2 patient groups

POET feeling

Experimental group

Description:

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

Treatment:

Behavioral: POET feeling

Supportive treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: Supportive treatment