Primary Care Online Emotion-regulation Treatment (POET)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: POET feeling, Supportive treatment.
- Who it may be relevant to
- Registry conditions: Mental Health Issue. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- 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 tea - 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.
Primary outcome measures
- The Clinical Global Impressions -Severity scale (CGI-S) [Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended]
Secondary outcome measures (12)
- The Clinical Global Impressions - Improvement scales (CGI-I) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended]
- The Work and Social Adjustment Scale (WSAS) [Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended]
- The Positive and Negative Affect Schedule for Children (PANAS-C) [Time frame: 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]
- The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) [Time frame: 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]
- Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) [Time frame: 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]
- The Process Model of Emotion Regulation Questionnaire -short (PMERQ-S) [Time frame: 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]
- The Perth Alexithymia Questionnaire-Short Form (PAQ-S) [Time frame: 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]
- Self-Efficacy Questionnaire for Children (SEQ-C) [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Karolinska Institutet — Stockholm
Publications
- Sjoblom K, Bellander M, Nilbrink J, Zetterqvist M, Sampaio F, Hedman-Lagerlof E, Hellner C, Gross JJ, Hesser H, Bjureberg J. Randomised superiority trial evaluating an online transdiagnostic emotion regulation treatment for adolescents with mental health conditions: study protocol. BMJ Open. 2026 Jul 29;16(7):e116511. doi: 10.1136/bmjopen-2026-116511. PMID 42526916
Identifiers
NCT: NCT06067165 · 2023-03652-01