Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder - a Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
研究概览
简要总结
Randomized controlled non-inferiority trial comparing therapist-guided Internet-based Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT for Obsessive-Compulsive Disorder (OCD) in adults.
The primary objective is to evaluate whether ICBT is a non-inferior treatment option compared to the best possible available treatment for OCD, individual face to face (f2f) CBT. A second objective is to compare the efficacy of self-guided vs. therapist-guided ICBT. As this question has cost implications for the health system, a third objective is to carry out a health economic evaluation of both forms of ICBT, in relation to the gold standard f2f CBT. A fourth objective is to explore whether ICBT is equally suited for clinic-referred cases compared to self-referred patients. Finally, a fifth objective is to investigate whether genetic markers, in combination with clinical variables, can be employed to predict treatment outcomes with CBT in general.
Research Questions:
Q1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f) CBT with regard to OCD symptoms, function and quality of life?
Q2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms, function and quality of life?
Q3: Is ICBT a cost-effective treatment, compared to f2f CBT?
Q4: Is there a difference in treatment outcome between self-referred and clinical referred patients?
Q5: Can clinical variables and genetic markers be useful to predict which patients will benefit from CBT?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age,
- •Internet access,
- •primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5),
- •Written consent of participation in the study.
排除标准
- •Other psychological treatment for OCD during the treatment period,
- •Adjustment of concurrent psychotropic medication within the last two months,
- •bipolar disorder,
- •psychosis,
- •alcohol or substance dependence,
- •completed CBT for OCD in the last 12 months,
- •hoarding disorder or OCD with primary hoarding symptoms,
- •suicidal ideation,
- •subjects that lack the ability to read written Swedish or lack the cognitive ability to assimilate to the written material,
- •Autism spectrum disorder,
- •organic brain disorder.
结局指标
主要结局
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
时间窗: Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.
次要结局
- Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders(Change from baseline to treatmentweek 15, 3- and 12-month follow-up.)
- Obsessive-Compulsive Inventory - Revised (OCI-R)(Change from baseline to treatmentweek 15, 3- and 12-month follow-up.)
- Clinical Global Impression - Improvement (CGI-I)(Treatmentweek 15, 3- and 12-month follow-up.)
- TiC-P(Treatmentweek 0, 15, 3- and 12-month follow-up.)
- Working Alliance Inventory - short revised(Change from baseline to treatment week 6 and 15)
- Yale-Brown Obsessive-Compulsive Scale - self-rated (Y-BOCS)(Change from baseline to treatmentweek 15, 3- and 12-month follow-up.)
- Sheehan Disability Scale (SDS)(Change from baseline to treatmentweek 15, 3- and 12-month follow-up.)
- Clinical Global Impression - Severity (CGI-S)(Change from baseline to treatmentweek 15, 3- and 12-month follow-up.)
- Montgomery-Åsberg Depression Rating Scale - self-rated (MADRS-S)(Change from baseline to treatmentweek 15, 3- and 12-month follow-up.)
- Insomnia Severity Index (ISI)(Treatmentweek 15, 3- and 12-month follow-up.)
- Treatment credibility scale(Change from baseline to treatmentweek 2.)
- Global Assessment of Functioning (GAF)(Change from baseline to treatmentweek 15, 3- and 12-month follow-up.)
- Euroqol (EQ-5D)(Change from baseline to treatmentweek 15, 3- and 12-month follow-up.)
- Patient EX/RP Adherence Scale (PEAS)(Treatmentweek 6 and 15)
- Satisfaction with treatment scale(Treatmentweek 15)
- Safety Monitoring Uniform Report Form (SMURF)(Treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.)
研究者
Christian Rück
Associate Professor
Karolinska Institutet