Mental Health Issue
Conditions
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.
Interventions
BEHAVIORALTherapist-supported digitally delivered transdiagnostic emotion regulation treatment
Please see description of experimental arm (arm one)
BEHAVIORALTherapist-supported digitally delivered supportive treatment
Please see description of active comparator arm (arm two)
Sponsors
Karolinska Institutet
Region Stockholm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Presenting with mental health problems
Exclusion criteria
* Acute suicidality and severe mental illness that require specialized care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of assessments | End of treatment 6 weeks after baseline | Completion of follow-up will be defined as completing at least one clinical outcome at end of intervention. |
| The fraction of eligible participants who consent to inclusion and randomization | End of treatment 6 weeks after baseline | We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomized persons. |
| Compliance | End of treatment 6 weeks after baseline | Compliance with the experimental intervention will be defined as completing at least three of six modules/sessions. |
| Child version or the Cognitive Emotion Regulation Questionnaire as explorative primary clinical outcome | Change from baseline, once every week during treatment (0-6 weeks after baseline) | Measure of emotion regulation |
| Revised Child Anxiety and Depression Scale as explorative primary clinical outcome | Change from baseline, once every week during treatment (0-6 weeks after baseline) | Measure of anxiety and depression symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children's Global Assessment Scale | Change from baseline, 6 weeks after treatment starts | Measure of global functioning |
| Emotion Regulation Diversity Index | Change from baseline, 6 weeks after treatment starts | Measure of emotion regulation flexibility |
| Strengths and Difficulties Questionnaire | Change from baseline, 6 weeks after treatment starts | Measure of youth strengths and difficulties |
| Brief 16-item Version of the Difficulties In Emotion Regulation | Change from baseline, 6 weeks after treatment starts | Measure of difficulties in emotion regulation |
| Emotion Regulation Questionnaire Child/Adolescents Version | Change from baseline, 6 weeks after treatment starts | Measure of difficulties in cognitive reappraisal and suppression |
| Beliefs About Emotions Questionnaire | Change from baseline, 6 weeks after treatment starts | Measure of beliefs about emotions |
Countries
Sweden
Outcome results
None listed