Clinical trial NCT06067165: Primary Care Online Emotion-regulation Treatment (POET)
Official title: Primary Care Online Emotion-regulation Treatment (POET)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Region Skane
name: Region Östergötland
First posted: 2023-10-04
Enrollment: 388
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: The Clinical Global Impressions -Severity scale (CGI-S)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Secondary outcomes:
measure: The Clinical Global Impressions - Improvement scales (CGI-I)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: The Revised Child Anxiety and Depression Scale-C (RCADS-C)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: The Revised Child Anxiety and Depression Scale-P (RCADS-P)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: Brief 11-item version of the Revised Child Anxiety and Depression Scale for Adolescents (RCADS-11)
timeFrame: 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
measure: Children's global assessment scale (CGAS)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: The Positive and Negative Affect Schedule for Children (PANAS-C)
timeFrame: 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
measure: The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
timeFrame: 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
measure: Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
timeFrame: 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
measure: The Process Model of Emotion Regulation Questionnaire -short (PMERQ-S)
timeFrame: 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
measure: The Perth Alexithymia Questionnaire-Short Form (PAQ-S)
timeFrame: 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
measure: Self-Efficacy Questionnaire for Children (SEQ-C)
timeFrame: 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
measure: Child Health Utility 9D (CHU-9D)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: Borderline symptoms checklist supplement (BSL-23)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: The Emotion Beliefs Questionnaire (EBQ)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: Behavioral emotion regulation questionnaire (BERQ)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
timeFrame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
measure: Deliberate Self-Harm Inventory, Youth version (DSHI-Y)
timeFrame: 3,12 and 60 months after treatment has ended
Other outcomes:
measure: The Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 after treatment start.
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 7 weeks after treatment start
measure: Patient Internet Cognitive behavior therapy Adherence Scale (PIAS)
timeFrame: 3 and 7 weeks after treatment start
measure: Questionnaire on Adverse events
timeFrame: 7 weeks after treatment start
measure: Academic performance
timeFrame: 5 years after after treatment has ended
measure: Occupation
timeFrame: 5 years after after treatment has ended
measure: Health-care consumption
timeFrame: 5 years after after treatment has ended
measure: Psychopharmacological treatment
timeFrame: 5 years after after treatment has ended
measure: Mental health disorders
timeFrame: 5 years after after treatment has ended
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Johan Bjureberg
role: PRINCIPAL_INVESTIGATOR
References: