Primary Care Online Emotion-regulation Treatment (POET)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 388
- 试验地点
- 2
- 主要终点
- The Clinical Global Impressions -Severity scale (CGI-S)
研究概览
简要总结
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.
详细描述
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:
- To test the effects of POET on mental health problems.
- To test the effects of POET on emotion regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors conducting post- and follow-up assessments will be blind to treatment allocation, for the full duration of the trial. The outcome measures are identical for both groups, ensuring that the assessors remain blind. To ensure blinding integrity, participants receive explicit instructions not to disclose which treatment participants have received. After completing the assessment, the blind raters guess the participant's group allocation and disclose the reason for their guess and record whether the participants has inadvertently revealed their group allocation. Blind assessments will be recorded to allow for calculation of inter-rater reliability.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12 - 17 years
- •Seeking care for mental health problems
- •At least one guardian interested in participating in the parent program
- •Deemed capable of making decisions
排除标准
- •Psychiatric problems that require more extensive treatment.
- •Low global functioning (under 41 points on clinician rated C-GAS or functioning that requires more extensive treatment).
- •Elevated suicide risk
- •Insufficient Swedish comprehension.
- •Life circumstances that complicate or make treatment impossible (eg severe deficits in parental care, domestic violence).
- •Change in psychopharmacological medication in the last 2 months.
- •Ongoing psychological treatment
结局指标
主要结局
The Clinical Global Impressions -Severity scale (CGI-S)
时间窗: 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.
次要结局
- The Revised Child Anxiety and Depression Scale-P (RCADS-P)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- Borderline symptoms checklist supplement (BSL-23)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- Brief 11-item version of the Revised Child Anxiety and Depression Scale for Adolescents (RCADS-11)(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)
- The Work and Social Adjustment Scale (WSAS)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)(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)
- Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- The Process Model of Emotion Regulation Questionnaire -short (PMERQ-S)(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)
- The Positive and Negative Affect Schedule for Children (PANAS-C)(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)
- Self-Efficacy Questionnaire for Children (SEQ-C)(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)
- Child Health Utility 9D (CHU-9D)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- Behavioral emotion regulation questionnaire (BERQ)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- The Clinical Global Impressions - Improvement scales (CGI-I)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- The Revised Child Anxiety and Depression Scale-C (RCADS-C)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- Children's global assessment scale (CGAS)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- The Perth Alexithymia Questionnaire-Short Form (PAQ-S)(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)
- The Emotion Beliefs Questionnaire (EBQ)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)(Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended)
- Deliberate Self-Harm Inventory, Youth version (DSHI-Y)(3,12 and 60 months after treatment has ended)
研究者
Johan Bjureberg
Associate Professor
Karolinska Institutet