Feasibility and efficacy of concentrated Exposure and Response Prevention therapy in patients with OCD
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Reduction in severity of OCD symptoms
研究概览
简要总结
Feasibility and efficacy of concentrated Exposure and Response Prevention Therapy in patients with Obsessive Compulsive Disorder
Single-group repeated measures design with four assessments for the primary outcome variable (baseline, 1-week, 4-weeks post-treatment, and 3-month follow-up). Participants will be recruited from the outpatient and inpatient services of NIMHANS, Bengaluru (Behavioral Medicine Unit, OCD Clinic, NCWB). The sample size estimated is 26 patients with moderate-to-severe OCD.
Intervention Concentrated Exposure and Response Prevention Therapy (ERP) to be delivered in an intensive short-term format over a period of one month.
Primary Objective
Assess the feasibility of concentrated ERP in patients with OCD and to evaluate the efficacy of concentrated ERP in reducing OCD symptom severity (Y-BOCS assessed by independent rater).
Secondary Objectives
Compare cost-effectiveness with published data on standard ERP.
Assess impact on anxiety, depression, and quality of life (HAM-A, HAM-D, EQ-5D).
Examine predictors of treatment outcome (distress tolerance, self-efficacy, homework adherence).
Procedure
The study will be conducted in two phases
- Pilot phase
The researcher will finalize tools and receive permissions from the respective authors. She will receive training to handle any exacerbation of OCD symptoms while doing intensive ERP. Pilot testing will be done for 3 patients with OCD. Based on the outcome, the intervention will be revised, and the frequency and duration of sessions will be finalized.
- Main phase
Potential participants will be approached for their participation in the study. Those meeting the inclusion criteria and giving informed consent will be assessed on baseline assessments. The content and format of intensive ERP will be thoroughly described to patients prior to inclusion in the study; they will be informed that the treatment will need their full attention and commitment. The finalized therapy module will be delivered. Assessments will be done pre, 1 week, and 4 weeks post-intervention and at a 3-month follow-up. YBOCS, PEAS/HCS measures will be repeated weekly.
Statistical Analysis Plan Repeated measures ANOVA, Reliable Change Index for clinical significance, cost-effectiveness using Incremental Cost-Effectiveness Ratio (ICER).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients meeting the primary diagnosis of Obsessive Compulsive Disorder as per the diagnostic criteria of ICD-
- •Y-BOCS score ranging from 16-31 (moderate-severe range) and a CGI score of 4 to 6 (moderately ill to severely ill).
- •Able to comprehend and understand spoken English and Hindi.
- •Patients that are drug-naive or stabilized on medication for 8 weeks prior to the inclusion in the study.
排除标准
- •Severe comorbid psychiatric conditions such as high suicide risk (as determined by FLII-11), severe major depression with psychotic features, psychosis, bipolar disorder, substance dependence (other than tobacco), severe personality disorder; Clinically determined Intellectual or other developmental disability (autism) that may compromise the ability to consent and participate in CBT; Patients with any past medical history of cardiac or pulmonary issues or hypertension.
- •Women who are pregnant will also be excluded.
- •Patients who have received more than three sessions of CBT for OCD in the previous year.
结局指标
主要结局
Reduction in severity of OCD symptoms
时间窗: Reduction in severity of OCD symptoms across 4 time points i.e. at baseline, 1 week, 3 weeks and 3 months post intervention
次要结局
- reduction in anxiety & depressive symptoms(3 time points i.e. at baseline, 3 weeks & 3 months post intervention)
- cost-effectiveness of concentrated Exposure & Response Prevention Therapy(3 time points i.e. at baseline, 3 weeks & 3 months post intervention)
- The role of distress tolerance, self-efficacy, & patient’s adherence to homework as predictors of outcome in concentrated ERP.(3 time points i.e. at baseline, 3 weeks & 3 months post intervention)
研究者
Ridhima Bassi
National Institute of Mental Health and Neurosciences