Implementation of Internet-delivered Cognitive-behavior Therapy for Paediatric Obsessive-compulsive Disorder in the Clinic: a Randomized Stepped Care Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 3
- 主要终点
- Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)
研究概览
简要总结
The purpose of this study is to investigate if therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped-care approach is an effective and cost-effective treatment in reducing OCD symptoms for children and adolescents compared to gold standard treatment (face-to-face CBT).
详细描述
A randomized controlled non-inferiority trial comparing therapist-guided internet-delivered cognitive behavioral therapy (ICBT) in a stepped care model with face-to-face CBT for children and adolescents with obsessive-compulsive disorder (OCD).
Participants will be randomized to either stepped care ICBT or to gold standard face-to-face CBT. One group (stepped care) will be first offered ICBT for 16 weeks. Non-responders at the 3-month follow-up will receive additional face-to-face CBT. The other group (gold standard treatment) will be randomized directly to receive face-to-face CBT for 16 weeks. Non-responders will, as in the other group, receive additional face-to-face treatment after the 3-month follow-up. The primary endpoint will be at 6-month follow-up. Long-term effects are also investigated (1 year, 2 years and 5 years after treatment completion).
The primary objective is to evaluate whether ICBT in a stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms, depression, impairment, sleep problems, health and functioning. The secondary objective is to a) carry out a full health economic evaluation and b) investigate if self-referred and referred participants differ regarding outcome in the two treatment groups.
The hypotheses are:
- An ICBT stepped care approach will be non-inferior to gold standard treatment (face-to-face CBT) in reducing OCD symptoms.
- The stepped care approach will be associated with lower costs, such as reduced therapist and administration times, service utilization, minimized work and school absence for families etc., compared to gold standard treatment.
- Self-referred patients will benefit significantly better than referred patients regarding outcome in the ICBT group, but there will not be any difference in the face-to-face CBT group.
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
- 7 Years 至 17 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 and 17 years
- •Ability to read and write Swedish and with access to a computer and use of internet.
- •Participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment. If the child is on medication for OCD, they will be requested to stay on stable doses for the duration of the trial.
排除标准
- •Organic brain disorders, global learning disabilities, autism spectrum disorder, psychosis, bipolar disorder and severe eating disorder.
- •Suicidal ideation
- •Not able to understand the basics of the ICBT self-help material, patient being housebound or in need of intensive- or in-patient treatment.
- •Having completed a course of CBT for OCD within the last 12 months (defined as at least 5 sessions CBT including exposure and response prevention).
- •Children with ongoing psychological treatment for OCD or another anxiety disorder will not be included in the study.
结局指标
主要结局
Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS)
时间窗: week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.
Change in OCD symptom severity from baseline to week 16 and 3 and 6 months after treatment has ended, and at 1, 2 and 5 years follow-up. Primary endpoint is 6 months follow-up.
次要结局
- Clinical global impression severity (CGI-S)(week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up)
- Obsessive-compulsive inventory - child version (OCI-CV)(week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment)
- Family accommodation scale for obsessive-compulsive disorder - self-rated version (FAS-SR)(week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up)
- Mood and Feeling Questionnaire (MFQ)(week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up)
- Children's global assessment scale (C-GAS)(week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up)
- Insomnia Severity Index (ISI)(week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up)
- Children's Obsessional Compulsive Inventory Revised - parent version (ChOCI-R)(week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up, and weekly during treatment)
- Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P)(week 0, week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up.)
- Education, work and social adjustment scale (EWSAS)(week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up)
- The Child Health Utility 9D (CHU9D)(week 0, week 16, at 3 and 6 months follow-up, at 1 year follow-up)
- Clinical global impression improvement (CGI-I)(week 16, at 3 and 6 months follow-up, at 1, 2 and 5 years follow-up)
研究者
Eva Serlachius
MD, associate professor
Karolinska Institutet