Clinical trial NCT05032547: Primary Care Online Emotion-regulation Treatment
Official title: Primary Care Online Emotion-regulation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2021-09-02
Enrollment: 30
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: We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental health problems.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Presenting with mental health problems

Exclusion Criteria:

* Acute suicidality and severe mental illness that require specialized care

Primary outcomes:
measure: Completion of assessments
timeFrame: End of treatment 6 weeks after baseline
measure: The fraction of eligible participants who consent to inclusion and randomization
timeFrame: End of treatment 6 weeks after baseline
measure: Compliance
timeFrame: End of treatment 6 weeks after baseline
measure: Child version or the Cognitive Emotion Regulation Questionnaire as explorative primary clinical outcome
timeFrame: Change from baseline, once every week during treatment (0-6 weeks after baseline)
measure: Revised Child Anxiety and Depression Scale as explorative primary clinical outcome
timeFrame: Change from baseline, once every week during treatment (0-6 weeks after baseline)
Secondary outcomes:
measure: Children's Global Assessment Scale
timeFrame: Change from baseline, 6 weeks after treatment starts
measure: Strengths and Difficulties Questionnaire
timeFrame: Change from baseline, 6 weeks after treatment starts
measure: Brief 16-item Version of the Difficulties In Emotion Regulation
timeFrame: Change from baseline, 6 weeks after treatment starts
measure: Emotion Regulation Questionnaire Child/Adolescents Version
timeFrame: Change from baseline, 6 weeks after treatment starts
measure: Beliefs About Emotions Questionnaire
timeFrame: Change from baseline, 6 weeks after treatment starts
measure: Emotion Regulation Diversity Index
timeFrame: Change from baseline, 6 weeks after treatment starts
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Gustavsberg's Vårdcentral
Study officials:
affiliation: Karolinska Institutet
name: Johan Bjureberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: