Primary Care Online Emotion-regulation Treatment

Mental Health Issue Clinical Trial

— POET  

Official title:

Primary Care Online Emotion-regulation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032547
• Other study ID #: POETF2022
• Status: Completed
• Phase: N/A
• Start date: October 16, 2022
• Est. completion date: June 6, 2023

Study information

• Verified date: January 2024
• Source: Region Stockholm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 6, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Presenting with mental health problems

Exclusion Criteria:

• Acute suicidality and severe mental illness that require specialized care

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• Therapist-supported digitally delivered transdiagnostic emotion regulation treatment
Please see description of experimental arm (arm one)
• Therapist-supported digitally delivered supportive treatment
Please see description of active comparator arm (arm two)

Locations

Country	Name	City	State
Sweden	Gustavsberg's Vårdcentral	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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	Children's Global Assessment Scale	Measure of global functioning	Change from baseline, 6 weeks after treatment starts
Secondary	Strengths and Difficulties Questionnaire	Measure of youth strengths and difficulties	Change from baseline, 6 weeks after treatment starts
Secondary	Brief 16-item Version of the Difficulties In Emotion Regulation	Measure of difficulties in emotion regulation	Change from baseline, 6 weeks after treatment starts
Secondary	Emotion Regulation Questionnaire Child/Adolescents Version	Measure of difficulties in cognitive reappraisal and suppression	Change from baseline, 6 weeks after treatment starts
Secondary	Beliefs About Emotions Questionnaire	Measure of beliefs about emotions	Change from baseline, 6 weeks after treatment starts
Secondary	Emotion Regulation Diversity Index	Measure of emotion regulation flexibility	Change from baseline, 6 weeks after treatment starts