NCT05032547

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 16, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

August 27, 2021

Last Update Submit

January 8, 2024

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • Children's Global Assessment Scale

    Change from baseline, 6 weeks after treatment starts

  • Strengths and Difficulties Questionnaire

    Change from baseline, 6 weeks after treatment starts

  • Brief 16-item Version of the Difficulties In Emotion Regulation

    Change from baseline, 6 weeks after treatment starts

  • Emotion Regulation Questionnaire Child/Adolescents Version

    Change from baseline, 6 weeks after treatment starts

  • Beliefs About Emotions Questionnaire

    Change from baseline, 6 weeks after treatment starts

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: Therapist-supported digitally delivered transdiagnostic emotion regulation treatment

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.

Behavioral: Therapist-supported digitally delivered supportive treatment

Interventions

Therapist-supported digitally delivered transdiagnostic emotion regulation treatmentBEHAVIORAL

Please see description of experimental arm (arm one)

Primary Care Online Emotion-Regulation Treatment
Therapist-supported digitally delivered supportive treatmentBEHAVIORAL

Please see description of active comparator arm (arm two)

Supportive Treatment

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Presenting with mental health problems

You may not qualify if:

  • Acute suicidality and severe mental illness that require specialized care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustavsberg's Vårdcentral

Stockholm, 134 40, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 40498482DERIVED

Study Officials

  • Johan Bjureberg, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Med Dr

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 2, 2021

Study Start

October 16, 2022

Primary Completion

February 24, 2023

Study Completion

June 6, 2023

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)