Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
研究概览
简要总结
The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition.
详细描述
The primary objective of this study is to test the efficacy of Internet-delivered cognitive behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a randomized controlled study with N = 66 participants. Participants will be randomly assigned to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better symptom reduction than the wait list condition.
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)
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
- •a primary diagnosis of OCD as defined by DSM-5
- •a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS
- •age between 12 and 17 years
- •ability to read and write Swedish
- •daily access to the internet
- •a parent that is able to co-participate in the treatment
- •Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
排除标准
- •diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating disorder
- •suicidal ideation
- •ongoing substance dependence
- •subject not able to read or understand the basics of the ICBT material
- •completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
- •ongoing psychological treatment for OCD or another anxiety disorder
结局指标
主要结局
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
时间窗: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment
次要结局
- Clinical Global Impression - Improvement, CGI-I(Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009)(Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- EQ-5D - quality of life(Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- Parent Adherence EX/RP Scale, PEAS(Baseline, 6 and 12 weeks after treatment starts)
- Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)(Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- Education, Work and Social Adjustment Scale - child and parent version (EWSAS)(Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998(Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)(Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- Technology acceptance scale(Baseline, 6 and 12 weeks after treatment starts,)
- Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)(Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- Clinical Global Impression - Severity, CGI-S(Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
研究者
Eva Serlachius
MD, PhD
Karolinska Institutet