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Completed

NCT Number: NCT05032547

Primary Care Online Emotion-regulation Treatment

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

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Key information

Conditions

Mental Health Issue

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustavsberg's Vårdcentral

Stockholm, 134 40, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presenting with mental health problems

Exclusion criteria

  • Acute suicidality and severe mental illness that require specialized care

Treatment and study plan

Therapist-supported digitally delivered transdiagnostic emotion regulation treatment

Behavioral

Please see description of experimental arm (arm one)

Therapist-supported digitally delivered supportive treatment

Behavioral

Please see description of active comparator arm (arm two)

Primary outcomes

  1. Completion of assessments

    Time frame: End of treatment 6 weeks after baseline

    Completion of follow-up will be defined as completing at least one clinical outcome at end of intervention.

  2. The fraction of eligible participants who consent to inclusion and randomization

    Time frame: End of treatment 6 weeks after baseline

    We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomized persons.

  3. Compliance

    Time frame: End of treatment 6 weeks after baseline

    Compliance with the experimental intervention will be defined as completing at least three of six modules/sessions.

  4. Child version or the Cognitive Emotion Regulation Questionnaire as explorative primary clinical outcome

    Time frame: Change from baseline, once every week during treatment (0-6 weeks after baseline)

    Measure of emotion regulation

  5. Revised Child Anxiety and Depression Scale as explorative primary clinical outcome

    Time frame: Change from baseline, once every week during treatment (0-6 weeks after baseline)

    Measure of anxiety and depression symptoms

Secondary outcomes

  1. Children's Global Assessment Scale

    Time frame: Change from baseline, 6 weeks after treatment starts

    Measure of global functioning

  2. Strengths and Difficulties Questionnaire

    Time frame: Change from baseline, 6 weeks after treatment starts

    Measure of youth strengths and difficulties

  3. Brief 16-item Version of the Difficulties In Emotion Regulation

    Time frame: Change from baseline, 6 weeks after treatment starts

    Measure of difficulties in emotion regulation

  4. Emotion Regulation Questionnaire Child/Adolescents Version

    Time frame: Change from baseline, 6 weeks after treatment starts

    Measure of difficulties in cognitive reappraisal and suppression

  5. Beliefs About Emotions Questionnaire

    Time frame: Change from baseline, 6 weeks after treatment starts

    Measure of beliefs about emotions

  6. Emotion Regulation Diversity Index

    Time frame: Change from baseline, 6 weeks after treatment starts

    Measure of emotion regulation flexibility

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Acronym: POET

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2021
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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