Primary Care Online Emotion-regulation Treatment

NCT ID: NCT05032547

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-16

Study Completion Date

2023-06-06

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.

Conditions

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Mental Health Issue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Primary Care Online Emotion-Regulation Treatment

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.

Group Type EXPERIMENTAL

Therapist-supported digitally delivered transdiagnostic emotion regulation treatment

Intervention Type BEHAVIORAL

Please see description of experimental arm (arm one)

Supportive Treatment

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.

Group Type ACTIVE_COMPARATOR

Therapist-supported digitally delivered supportive treatment

Intervention Type BEHAVIORAL

Please see description of active comparator arm (arm two)

Interventions

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Therapist-supported digitally delivered transdiagnostic emotion regulation treatment

Please see description of experimental arm (arm one)

Intervention Type BEHAVIORAL

Therapist-supported digitally delivered supportive treatment

Please see description of active comparator arm (arm two)

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Region Stockholm

OTHER_GOV

Sponsor Role lead

Responsible Party

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Johan Bjureberg

Med Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan Bjureberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Gustavsberg's Vårdcentral

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 40498482 (View on PubMed)

Other Identifiers

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POETF2022

Identifier Type: -

Identifier Source: org_study_id

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