Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder: a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Children´s Yale Brown Compulsive Scale (CY-BOCS)
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and effectiveness of Internet-delivered Cognitive Behavior Therapy (ICBT) for children (7-11 years) with Obsessive-Compulsive Disorder (OCD).
详细描述
The primary objective of this study is to investigate if Internet-delivered Cognitive Behavior Therapy (ICBT) is a feasible and effective treatment for children (7-11 years) with Obsessive-Compulsive Disorder (OCD). The design of the study is a pilot study with 16 participants. The treatment duration is 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary DSM-5 diagnosis of OCD
- •Total score of ≥16 on the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
- •Age between 7-11 years
- •Ability to understand Swedish
- •Daily access to the Internet
- •A parent that can co-participate in the treatment
- •Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment
排除标准
- •Diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability
- •Suicidal ideation
- •Not able to understand the basics of the ICBT self-help material
- •Have completed a course of CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
- •On-going psychological treatment for OCD or another anxiety disorder
研究组 & 干预措施
Internet-delivered Cognitive-Behavioral Therapy
干预措施: Internet-delivered Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Children´s Yale Brown Compulsive Scale (CY-BOCS)
时间窗: week 0, week 12, at 3 months follow up
Change in obsessions and compulsions from baseline to week 12 and at 3 months after treatment has ended
次要结局
- Clinical Global Impression - Severity (CGI-S)(week 0, week 12, at 3 months follow up)
- Family Accommodation Scale - Self Rated (FAS-SR)(week 0, week 12, at 3 months follow up)
- Euroqol - Youth (EQ-5D-Y)(week 0, week 12, at 3 months follow up)
- Safety Monitoring Uniform Report Form (SMURF)(week 6, week 12)
- Autism Spectrum Quotient (AQ-10)(week 0)
- Child Depression Inventory - Short version (CDI-S)(week 0, week 12, at 3 months follow up)
- Internet Intervention Patient Adherence Scale (iiPAS)(week 6, week 12)
- Children's Obsessional Compulsive Inventory Revised - Parent version (ChOCI-R-P)(week 0, week 12, at 3 months follow up and weekly during treatment)
- Clinical Global Impression - Improvement (CGI-I)(week 12, at 3 months follow up)
- Education, Work and Social Adjustment Scale - child and parent version (EWSAS)(week 0, week 12, at 3 months follow up)
- Mood and Feeling Questionnaire - parent version (MFQ)(week 0, week 12, at 3 months follow up)
- Children's Global Assessment Scale (C-GAS)(week 0, week 12, at 3 months follow up)
- Obsessive-Compulsive Inventory - Child Version (OCI-CV)(week 0, week 12, at 3 months follow up and weekly during treatment)
- Qualitative data on treatment credibility(week 3)
- Qualitative data on treatment satisfaction(week 12)
- Patient Exposure/Response prevention Adherence Scale (PEAS)(week 6, week 12)
研究者
Eva Serlachius
MD, PhD
Karolinska Institutet