Efficacy of video-conference based cognitive behavioural therapy (v-CBT) in comparison with in-person cognitive behaviour therapy (IP-CBT) for obsessive-compulsive disorder: A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Reduction in total score of Yale-Brown Obsessive Compulsive Scale which assess Obsessive compulsive symptom severity.
研究概览
简要总结
Cognitive behavior therapy (CBT) is the first line of treatment for OCD. With a limited number of trained therapists and the majority working in megacities, a large chunk of the population has difficulties accessing standard first-line treatment; this gap may be bridged by using Video conference-based CBT (v-CBT). V-CBT may be a flexible, cost-effective treatment easily applicable to people far from megacities. The present study will answer whether v-CBT is non-inferior to in-person CBT for OCD. The study’s primary objective is to test the efficacy of v-CBT compared to in-person CBT in reducing the severity of OCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults over age 18 years;
- •Primary diagnosis of DSM-5 OCD;
- •Y-BOCS total severity score between
- •On stable medications for at least 8 weeks prior to inclusion.
排除标准
- •Severe comorbid psychiatric conditions such as high suicide risk (as determined by SCID-CV screening questions on suicidality), severe major depression, psychosis, bipolar disorder, substance dependence (other than tobacco);
- •Clinically determined Intellectual or other developmental disability that may compromise the ability to consent and participate in CBT;
- •Having received CBT of at least 10 sessions for OCD in the past year.
结局指标
主要结局
Reduction in total score of Yale-Brown Obsessive Compulsive Scale which assess Obsessive compulsive symptom severity.
时间窗: Outcome assessments will be done by independent assessors who will be blind to the allocation. The primary end-point of the study will be after the intervention (Three months of intervention in both groups). The primary outcome in both groups will be assessed every two weeks during the intervention and one month and six months of follow-up. This would enable us to evaluate the rapidity and the sustainability of response.
次要结局
- Reduction of total score on Montgomery-Ã…sberg Depression Rating Scale which assess severity of depression.(Baseline, post intervention, one month & 6 month follow ups will be used the time point for assessing patients level of depression by using Montgomery-Ã…sberg Depression Rating Scale.)
- Reduction of total score on Hamilton Anxiety Rating Scale will be secondary outcome variable.(Baseline, post intervention, one month & six month follow ups will be considered the time point for assessing patients level of level of Anxiety using Hamilton Anxiety Rating Scale.)
- Improvement in the Global Assessment of Functioning & World Health Organization Quality of Life-Brief scores will be the outcome variable.(Baseline, post-intervention, one-month, & six-month follow-up will be used as time points for the assessment of functioning & quality of life using the Global Assessment of Functioning & World Health Organization Quality of Life-Brief.)
研究者
Dr Ajay Kumar
National Institute of Mental Health and Neurosciences