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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental health problems.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Care Online Emotion-Regulation Treatment | Experimental | 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. |
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| Supportive Treatment | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapist-supported digitally delivered transdiagnostic emotion regulation treatment | Behavioral | Please see description of experimental arm (arm one) |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Bjureberg, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustavsberg's Vårdcentral | Stockholm | 134 40 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40498482 | Derived | Sjoblom K, Frankenstein K, Klintwall L, Nilbrink J, Zetterqvist M, Hesser H, Hedman-Lagerlof E, Gross JJ, Hellner C, Bellander M, Bjureberg J. Online Transdiagnostic Emotion Regulation Treatment for Adolescents With Mental Health Problems: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2514871. doi: 10.1001/jamanetworkopen.2025.14871. |
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| Therapist-supported digitally delivered supportive treatment | Behavioral | Please see description of active comparator arm (arm two) |
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| 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 |