Four-day Intensive Treatment Versus Standard Cognitive Behavioral Therapy for Adults With Obsessive-compulsive Disorder: a Single-blind, Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), clinician-administered
研究概览
简要总结
The goal of this clinical trial is to compare a novel, condensed version of cognitive behavioral therapy (Bergen 4-Day Treatment, B4DT) to the gold standard psychological treatment (gold-standard CBT) for obsessive compulsive disorder (OCD).
The main question it aims to answer is:
• Is B4DT non-inferior to standard cognitive behavioral therapy (CBT) with regard to OCD symptoms 14 weeks after treatment start?
Adult patients with obsessive compulsive disorder will be randomly assigned to receive either gold standard CBT one to two times per week for 14 weeks, or 4 days of B4DT during one week.
详细描述
Obsessive-compulsive disorder is a persistent and disabling psychiatric disorder. Individual cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) is an effective treatment for OCD and is recommended as a first-line intervention. However, patients need to remain in treatment for several months and even after that, around 50% remain symptomatic despite this lengthy treatment. In response to this, a novel, condensed version of CBT, B4DT, has been developed. B4DT has shown promising results in several uncontrolled trials and one randomized controlled trial with inactive control, however it has yet to be directly compared to gold-standard individual CBT.
This single blind, randomized controlled trial with 120 patients (60 per arm) will compare B4DT to gold standard CBT. The primary outcome is the blind-rater administered Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The investigators hypothesize that B4DT will be non-inferior to gold standard CBT 14 weeks after treatment start. The non-inferiority margin is set at 4 points on the Y-BOCS.
Secondary outcomes are cost effectiveness, speed of response, response and remission rates, dropout rate, and negative effects. The investigators hypothesise that participants that receive B4DT will improve faster than patients that receive standard CTB, but for the rest of the secondary outcomes, the investigators have no directed hypotheses.
A more detailed preregistration, and all analysis scripts, are available at Open Science Framework (https://osf.io/w5bfp/).
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 (Investigator, 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.
- •Primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5).
- •Clinician-rated Y-BOCS score of ≥ 16
- •Written informed consent.
- •To be willing and able to attend treatment at any one of the two treatment clinics, regardless of the clinic where the initial assessment took place (the two clinics are located at different locations in Stockholm, about 20 Km apart).
- •Be fluent in Swedish.
排除标准
- •Other psychological treatment for OCD planned during trial period.
- •Completed CBT with ERP for OCD in the last 12 months.
- •Changes in psychotropic medication within the last 2 months.
- •Bipolar disorder.
- •Alcohol or substance dependence.
- •Organic brain disorder.
- •Hoarding disorder or OCD with primary hoarding symptoms.
- •Suicidal ideation that would warrant close monitoring.
研究组 & 干预措施
Bergen 4-Day Treatment (B4DT)
Patients in this arm will receive an intensive treatment delivered mostly in group format. The group sizes will be 3-6 participants with a 1:1 patient to therapist ratio. In the week before the intensive part of the treatment, participants will have two scheduled phone/video calls with a therapist. Day 1 (half-day) of the intensive treatment includes psychoeducation and deciding on exposure tasks. Days 2 and 3 (whole days) focus on individually tailored and therapist-assisted ERP in as many most relevant settings as possible. In the evenings, patients are encouraged to continue with self-guided ERP and may receive therapist support via text messages or phone calls on demand. On day 3, patients can invite relatives to a psychoeducation session. Day 4 (half-day) of the intensive treatment focuses on treatment summary and relapse prevention, as well as planning self-guided ERP for the upcoming 3 weeks.
After 16 weeks, participants have individual follow-up sessions without ERP.
干预措施: Bergen 4-Day Treatment (B4DT) (Behavioral)
Gold standard cognitive behavioral therapy (gold standard CBT)
Patients will receive 16 sessions of individual CBT for OCD with an emphasis on ERP, delivered over a time period of 14 weeks according to a validated protocol. Sessions will be held twice weekly at a specialist clinic during the first 2 weeks and once a week for the remaining 12 weeks. Sessions 1-2 contain psychoeducation about OCD and CBT, goal setting, and planning of ERP exercises. Sessions 3-14 include therapist-guided ERP (at the clinic, in the patients' homes or elsewhere as needed) with planned self-practice ERP between sessions. Sessions 15-16 contain a summary of the treatment and lessons learned, as well as relapse prevention and planning of continued self-practice ERP.
干预措施: Gold standard cognitive behavioral therapy (gold standard CBT) (Behavioral)
结局指标
主要结局
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), clinician-administered
时间窗: Change from baseline to 14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up
Clinician administered scale that measures the severity of obsessions and compulsions. Ten questions, with scores ranging from 0 to 4 (most severe), address time, interference, distress, resistance and control over obsessions and compulsions (total score range from 0 to 40).
次要结局
- Clinical Global Impression - Severity (CGI-S)(14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up)
- Clinical Global Impression - Improvement (CGI-I)(14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up)
- Dropout rate in both arms(Gold standard CBT: week 15. B4DT: week 3.)
- Treatment Inventory of Costs in Psychiatric Patients (TIC-P)(Pre-treatment, at week 15, and at the 7- and 16-month follow-ups)
- Negative Effects Questionnaire (NEQ)(14 weeks after treatment start. Additional measures at the 7- and 16-month follow-ups)
- Assessing Quality of Life 6 Dimensions (AQoL-6D)(Change from baseline to 14 weeks after treatment start. Additional measures at the 7- and 16-month follow-ups)
研究者
Christian Rück
Professor
Karolinska Institutet