Primary Care Online Emotion-regulation Treatment (POET)

NCT06067165 | Recruiting

• 1 other identifier: 2023-03652-01
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (1)

• The Clinical Global Impressions -Severity scale (CGI-S)

  Used to assess symptom severity rated on a single item ranging from 1-7, with higher scores indicating more severe symptoms. Clinician-rated.

  Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended

Secondary Outcomes (20)

• The Clinical Global Impressions - Improvement scales (CGI-I)

  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)

  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)

  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)

  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)

  Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended

Other Outcomes (9)

• The Credibility/Expectancy Questionnaire (CEQ)

  Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 after treatment start.

• Client Satisfaction Questionnaire (CSQ)

  7 weeks after treatment start

• Patient Internet Cognitive behavior therapy Adherence Scale (PIAS)

  3 and 7 weeks after treatment start

Study Arms (2)

POET feeling

EXPERIMENTAL

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

Behavioral: POET feeling

Supportive treatment

ACTIVE COMPARATOR

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.

Behavioral: Supportive treatment

Interventions

POET feeling 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.

POET feeling

Supportive treatment 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.

Supportive treatment

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Region Skane: collaborator
• Region Östergötland: collaborator
• Västra Götalandsregionen: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 113 64, Sweden

RECRUITING

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Johan Bjureberg

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Bjureberg, PhD

CONTACT

+460852480000; johan.bjureberg@ki.se

Katja Sjöblom, MSc

CONTACT

+460812339504; katja.sjoblom@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: October 4, 2023
• Study Start: October 16, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 25, 2031
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)