Primary Care Online Emotion-regulation Treatment (POET)

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

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Behavioral: Therapist-supported digitally delivered transdiagnostic emotion regulation treatment; Behavioral: Therapist-supported digitally delivered supportive treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 134 40
    • Gustavsberg's Vårdcentral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presenting with mental health problems

Exclusion Criteria:

• Acute suicidality and severe mental illness that require specialized care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Therapist-supported digitally delivered transdiagnostic emotion regulation treatment; Please see description of experimental arm (arm one)
Active Comparator: 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.	Behavioral: Therapist-supported digitally delivered supportive treatment; Please see description of active comparator arm (arm two)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Region Stockholm
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Johan Bjureberg, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2022
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: POETF2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No