Primary Care Online Emotion-regulation Treatment

Study Overview
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Brief Summary
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We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental health problems.

Detailed Description
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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 are creating substantial economic costs to society. Existing treatments are not fully addressing these problems because they focus on a subset of mental health problems; they are limited in efficacy; and are not provided to most youth in need. Transdiagnostic digital treatments that address mechanisms underlying mental health problems, such as emotion regulation, have been called for to address these problems. As an initial pilot study we will include 60 participants aged 12-17 years and their parents in a randomized controlled feasibility trial comparing a 6-week Primary care Online Emotion-regulation Treatment (POET) to a 6-week active Supportive Treatment (ST). Both interventions will be delivered in blended format combining online therapist-supported treatment modules with a video-link session. The primary study aims are to examine the feasibility and acceptability of study protocol and treatment protocols. Preliminary utility of the experimental condition will be evaluated by youth-reported, parent-reported, and clinical-reported outcomes.

Official Title
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Primary Care Online Emotion-regulation Treatment

Conditions
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Mental Health Issue

Intervention / Treatment
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* Behavioral: Therapist-supported digitally delivered transdiagnostic emotion regulation treatment
* Behavioral: Therapist-supported digitally delivered supportive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting with mental health problems Exclusion Criteria: Acute suicidality and severe mental illness that require specialized care

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Care Online Emotion-Regulation Treatment<br>The youth component in the experimental condition will include psychoeducation, addressing maladaptive beliefs about emotions and emotion regulation, and teaching adaptive emotion regulation strategies, such as mindfulness practice and acceptance of emotions and flexible cognitive reappraisal. The parent component will include psychoeducation and teaching effective responding to their children's and their own emotions. | Behavioral: Therapist-supported digitally delivered transdiagnostic emotion regulation treatment<br>* Please see description of experimental arm (arm one)<br>|
| Active Comparator: Supportive Treatment<br>The intervention will be delivered in a blended treatment format combining asynchronous therapist-guided online modules (text/videos/audio/messaging function) with a synchronous session delivered over video-link. | Behavioral: Therapist-supported digitally delivered supportive treatment<br>* Please see description of active comparator arm (arm two)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of assessments | Completion of follow-up will be defined as completing at least one clinical outcome at end of intervention. | End of treatment 6 weeks after baseline | 
| The fraction of eligible participants who consent to inclusion and randomization | We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomized persons. | End of treatment 6 weeks after baseline | 
| Compliance | Compliance with the experimental intervention will be defined as completing at least three of six modules/sessions. | End of treatment 6 weeks after baseline | 
| Child version or the Cognitive Emotion Regulation Questionnaire as explorative primary clinical outcome | Measure of emotion regulation | Change from baseline, once every week during treatment (0-6 weeks after baseline) | 
| Revised Child Anxiety and Depression Scale as explorative primary clinical outcome | Measure of anxiety and depression symptoms | Change from baseline, once every week during treatment (0-6 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Global Assessment Scale | Measure of global functioning | Change from baseline, 6 weeks after treatment starts | 
| Strengths and Difficulties Questionnaire | Measure of youth strengths and difficulties | Change from baseline, 6 weeks after treatment starts | 
| Brief 16-item Version of the Difficulties In Emotion Regulation | Measure of difficulties in emotion regulation | Change from baseline, 6 weeks after treatment starts | 
| Emotion Regulation Questionnaire Child/Adolescents Version | Measure of difficulties in cognitive reappraisal and suppression | Change from baseline, 6 weeks after treatment starts | 
| Beliefs About Emotions Questionnaire | Measure of beliefs about emotions | Change from baseline, 6 weeks after treatment starts | 
| Emotion Regulation Diversity Index | Measure of emotion regulation flexibility | Change from baseline, 6 weeks after treatment starts |