A Pilot Randomised Controlled Trial to Assess the Feasibility of Cognitive Behavioural Therapy (CBT) Delivered in Time-Intensive and Weekly Treatment Formats for Treatment Resistant Obsessive Compulsive Disorder (OCD).
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Yale- Brown Obsessive Compulsive Scale (Y-BOCS) & Obsessive Compulsive Inventory
研究概览
简要总结
The purpose of this study is to examine how feasible and acceptable it is to deliver a talking treatment called Cognitive Behavioural Therapy (CBT) in two different formats for people who have had treatment for OCD in the past but it didn't work out for them.
The two different treatment formats are CBT delivered on a weekly basis (which is approximately 12-18 hours of therapy delivered weekly for 60-90 minutes each session, followed by 1-3 monthly follow up sessions as needed) and CBT offered in an intensive format (which is having approximately 12-18 hours of therapy all in a 3-week period, followed by 1-3 monthly follow up sessions as needed).
详细描述
The main aim of this study is to assess the feasibility and acceptability of Intensive CBT for treatment resistant OCD when participants are randomized to this format.
This study aims to establish an estimate of the relative efficacy of both Intensive and Weekly CBT when compared individually to wait list, for participants with a diagnosis of OCD, who have previously not responded to CBT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of OCD (as confirmed by the administration of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th ed.) (DSM-IV) (SCID-I) .
- •Participant identifies their main problem as OCD.
- •Participant has not responded to one or more trials CBT
- •Yale-Brown Obsessive Compulsive Scale (YBOCS) score of 16 or above.
- •No change in psychotropic medication (if applicable) for at least 8 weeks prior to study entry. (If such a change has taken place there will be an option for the participant to take part once the medication has been stabilised).
- •No intention to change psychotropic medication during the course of the trial
- •Able to speak and read every day English
排除标准
- •Severe psychiatric problem that requires separate treatment at an immediate basis and is linked to risk.
- •Drug and/or alcohol dependence in last three months
- •History of Psychosis or Bipolar Disorder
结局指标
主要结局
Yale- Brown Obsessive Compulsive Scale (Y-BOCS) & Obsessive Compulsive Inventory
时间窗: Assessment, end of treatment (at 3 weeks for Intensive & 12-15 weeks for weekly treatment) and follow up (at 3 & 6 months post treatment completion for both groups).
The Y-BOCS is Clinician administered and the OCI is self report, both measures assess the severity of OCD symptoms. These measures will be used to assess change in symptom severity from base line to end of treatment and to assess if there has been a change at end of treatment, if this is maintained at 3 and 6 months following the completion of treatment.
次要结局
未报告次要终点
研究者
Josie Millar
Lecturer & Clinical Psychologist
University of Bath