Karolinska Institutet
Stockholm, 113 64, Sweden
Location status: Recruiting
NCT Number: NCT06067165
Mental health problems in youth are a global problem, causing incalculable suffering in youth and families, harming long-term prospects of youths, and creating substantial economic costs to society.
The overall objective of this study is to build an evidence base for a highly scalable transdiagnostic intervention called the Primary care Online Emotion-regulation Treatment (POET) for youth (12-17 years) seeking treatment for mental health problems.
In a randomized controlled trial, the investigators will examine the effects of POET. The investigators will test if emotion regulation mediates reduction in mental health problems during treatment. In addition the investigators will test if POET is more effective for some individuals than others and evaluate if POET is cost-effective. The investigators will also test whether there are detectable effects of POET on distal outcomes utilizing registry data following participants up to 10 years post treatment.
Interested in participating?
Request Info12 year–17 year
All sexes
Interventional
Not applicable
Stockholm, 113 64, Sweden
Location status: Recruiting
Introduction:
Mental health problems among young people are prevalent and many youth in need of treatment for mental health problems do not meet criteria for any mental health disorder or they meet criteria for several disorders. Most existing treatments focus on a subset of mental disorders and do not address subthreshold or multi-disorder mental health problems. In addition, available treatments do not typically target transdiagnostic disease mechanisms. Furthermore, the available treatments are limited in efficacy and most youth in need do not receive treatment due to social stigma and structural barriers such as geographical distance to treatment providers.
The aim of this randomized clinical trial is to determine the clinical efficacy of a digital emotion regulation treatment in adolescents with mental health problems. Participants will be randomized to a digital emotion regulation treatment or to an active comparator. Treatments in both conditions will include therapist support, and will be delivered in a blended treatment format combining asynchronous therapist-guided online modules with one synchronous session delivered over video-link. The primary endpoint is at post- treatment.
Primary objectives:
Secondary objectives:
Research questions:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
POET is adapted from online Emotion Regulation Individual Therapy for Adolescents developed by the research group (ClinicalTrials.gov Identifier: NCT03353961).
POET is also based on the Modal model of emotion and Process model of emotion regulation that provides a framework for understanding how emotions are generated, experienced and how they can be regulated. The youth component of POET will include psychoeducation, addressing maladaptive beliefs about emotions and emotion regulation, and teaching adaptive emotion regulation strategies, such as acceptance of emotions and flexible cognitive reappraisal. The parent component will include psychoeducation and teaching effective support and responding to their adolescent's and their own emotions.
The treatment will include educative material on mental health and self-reflection on themes such as school, family and friends. The parent component will include educative material and self reflection in how to support their adolescent.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess symptom severity rated on a single item ranging from 1-7, with higher scores indicating more severe symptoms. Clinician-rated.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess symptom improvement rated on a single item ranging from 1-7, with lower scores indicating more improvement. Clinician-rated.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess symptoms of depression and anxiety. This scale has 47 items, total score ranging from 0 to 141, with higher scores indicating more severe symptoms. Clinician-rated.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess symptoms of depression and anxiety in their offspring. This scale has 47 items, total score ranges from 0 to 141 points, with higher scores indicating more severe symptoms. Caregiver-reported.
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Used to assess symptoms of depression and anxiety in children and adolescents. This scale has 11 items, total score ranges from 0-33 points, with higher scores indicating more severe symptoms. Self-rated by adolescents.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess global impairment on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess impaired functioning in school, everyday life, friends and social life, recreation and hobbies and family and close relationships. This scale has 5 items, total score ranges from 0 to 40, with higher scores indicating greater impairment. Clinician-rated.
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Used to assess positive and negative feelings. This scale has 2 subscales. Each total subscale score range from 5-25, with higher scores indicating more negative or positive feelings. Self-rated by adolescents.
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Used to assess cognitive reappraisal. The subscale has 6 items, total subscale score ranges from 6-30, with higher scores indicating greater usage of cognitive reappraisal. Self-rated by adolescents.
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Used to assess difficulties in emotion regulation. The scale has 16 items, total score ranges from 16-80, with higher scores indicating more difficulties. Self-rated by adolescents.
One subscale named impulse (3 items ranging from 3-15) will be administered once every week during treatment.
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Used to assesses individual differences in emotion regulation. This scale has 30 items, total score ranges from 30-180, with higher scores indicate a greater usage of emotion regulation. Self-rated by adolescents.
The three subscales named Confront unpleasant situations (3 items, total subscale score ranges from 6-18), Avoid unpleasant situations (3 items, total subscale score ranges from 6-18) and Cognitively distract (3 items, total subscale score ranges 6-18) will administered to adolescents weekly.
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Used to assess alexithymia. This scale has 6 items, total score ranges from 6 to 42, with higher scores indicate higher levels of alexithymia. Self-rated by adolescents.
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Used to assess social self-efficacy. The subscale named social self-efficacy has 8 items, total subscale score ranges from 8-40, with higher scores indicating greater social self-efficacy. Self-rated by adolescents.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess health-related quality of life. This scale has 9 items, total score ranges from 9 to 45, with higher scores indicating worse quality of life. Self-rated by adolescents.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess high-risk and problematic behaviors. This scale has 10 items, total score ranges from 0 to 40, with higher scores indicating greater usage of high-risk and problematic behaviors. Self-rated by adolescents.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess beliefs about emotions. This scale 16 items, total score ranges from 16 to 112, with higher scores indicating more maladaptive beliefs about emotions. Self-rated by adolescents.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess parents' perceived ability to cope with children's negative emotions. This scale has six subscales which include emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses. Each subscale has 9 items, total subscale score ranges from 1-7, with higher scores indicating greater usage of a certain parental coping style. Care-giver reported.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess difficulties in emotion regulation. The scale has 16 items, total score ranges from 16-80, with higher scores indicating more difficulties. Self-rated by parents.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess parents' perception of the adolescent's behavioral emotion regulation. This scale has 5 subscales. Each total subscale score ranges from 4-20, with higher scores indicating greater usage of a certain strategy. Care-giver reported.
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess healthcare and other societal resource use for both children and caregivers. Caregiver-reported.
Time frame: 3,12 and 60 months after treatment has ended
Used to assess occurrence, method, frequency of deliberate self-harm. This scale has 6 items with higher scores indicating more frequent deliberate self-harm. Self-rated by adolescents.
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 after treatment start.
Used to assess treatment credibility and expectancy. The scale has 5 items ranging from 4-58 with higher scores indicating greater credibility/expectancy. Clinician-reported, adolescents self-rated, care-giver reported.
Time frame: 7 weeks after treatment start
Used to assess client satisfaction with treatment. This scale has 8 items ranging from 8-32 points with higher scores indicating greater treatment satisfaction. Adolescents self-rated, care-giver reported.
Time frame: 3 and 7 weeks after treatment start
Used to assess patient adherence to internet-delivered behavioral interventions. This scale has 5 items, total score ranging from 0 to 20, where 0 indicates no adherence and 20 perfect adherence. Clinician-rated.
Time frame: 7 weeks after treatment start
Used to assess adverse events related to treatment. Adolescents are asked to report any negative effects or adverse events throughout the treatment period. Adolescents are also requested to report the extent of the impact of any potential adverse events on their well-being using a 0-4 scale, with a higher score indicating a more significant impact. Adolescent self-reported.
Time frame: 5 years after after treatment has ended
Grades in school using data from the Swedish registry Longitudinal Integration Database for Health Insurance and Labour Market Studies (LISA).
Time frame: 5 years after after treatment has ended
Unemployment rates using data from the Swedish registry Longitudinal Integration Database for Health Insurance and Labour Market Studies (LISA) that contains information on occupation.
Time frame: 5 years after after treatment has ended
Number of health care visits using data from the National (Sweden) Patient Register.
Time frame: 5 years after after treatment has ended
Number of psychotropic medications using data from National (Sweden) Prescribed Drug Register.
Time frame: 5 years after after treatment has ended
Number of mental disorders according to the ICD-10 and ICD-11 using data from the National (Sweden) Patient Register.
Contact information is provided by the study sponsor or research team.
Johan Bjureberg, PhD
CONTACT
Katja Sjöblom, MSc
CONTACT
Karolinska Institutet
Other
Acronym: POET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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