Primary Care Online Emotion-regulation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Compliance
研究概览
简要总结
We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental health problems.
详细描述
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.
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
- Double (Participant, Outcomes Assessor)
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
- •Presenting with mental health problems
排除标准
- •Acute suicidality and severe mental illness that require specialized care
结局指标
主要结局
Compliance
时间窗: 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
时间窗: 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
时间窗: Change from baseline, once every week during treatment (0-6 weeks after baseline)
Measure of anxiety and depression symptoms
Completion of assessments
时间窗: 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
时间窗: 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.
次要结局
- Children's Global Assessment Scale(Change from baseline, 6 weeks after treatment starts)
- Brief 16-item Version of the Difficulties In Emotion Regulation(Change from baseline, 6 weeks after treatment starts)
- Emotion Regulation Questionnaire Child/Adolescents Version(Change from baseline, 6 weeks after treatment starts)
- Emotion Regulation Diversity Index(Change from baseline, 6 weeks after treatment starts)
- Beliefs About Emotions Questionnaire(Change from baseline, 6 weeks after treatment starts)
- Strengths and Difficulties Questionnaire(Change from baseline, 6 weeks after treatment starts)
研究者
Johan Bjureberg
Med Dr
Karolinska Institutet