Efficacy of Cognitive Behaviour Therapy -v- Anxiety Management for Body Dysmorphic Disorder: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)
研究概览
简要总结
The aim of the research is to determine if Cognitive Behaviour Therapy (CBT) specific for BDD is more effective than a credible non-specific form of CBT for treating BDD and its delusional variant in adults aged 17 or over. This will be done in a single centre randomised controlled trial that compares specific CBT for BDD versus non-specific CBT over 12 weeks. The hypotheses to be tested are that: (1) specific CBT for BDD will be more effective than non-specific CBT at 12 weeks (2) Treatment effects from Specific CBT will be maintained at 1 month follow up. The main study end-point is at 12 weeks and the secondary end-point is at 1 month follow up. A secondary aim is to explore whether delusionality (insight) as measured by the Brown Assessment of Beliefs and co-morbid depressed mood predicts response to treatment.
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
- 17 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BDD is the main psychological problem. We will use DSMIV criteria as BDD does not exist as a separate diagnosis in ICD
- •They may have an additional diagnosis of Delusional Disorder when it refers to beliefs about being ugly or defective.
- •They must have a total of 24 or more on the twelve-item YBOCS modified for BDD (Phillips et al., 1997).
- •They may be of either gender but must be 17 years or above.
- •They are willing to travel to the treatment centre for weekly sessions.
- •They are wiling to complete regular questionnaires and be audiotaped for supervision and for listening to enhance their learning.
- •They may be taking psychotropic medication so long as it is stabilised and there are no plans to increase the dose.
排除标准
- •They have a current or past diagnosis of schizophrenia, bipolar affective disorder.
- •They have current suicidal intent or severe self-neglect that requires hospitalisation.
- •They have a current alcohol or substance dependence or anorexia nervosa or borderline personality disorder that requires treatment in its own right.
- •They are currently receiving any other form of psychotherapy,
- •They have received CBT for BDD in the past 6 months, which is judged as competently delivered and did not respond.
- •They cannot speak sufficient English for CBT. (Assistance will be provided for those who speak English but are unable to read questionnaires).
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)
时间窗: 12 weeks, 1 month post treatment
This is a clinician-rated scale administered by a trained blinded assessor. The range is 0-48. Cronbach's α for the scale is 0.80. Response to treatment is defined as a 30% or greater decrease in the total BDD-YBOCS score, which best corresponded to 'much improved' on the Clinical Global Impression (CGI) scale. In the original validation study, this cutoff score produced 1 false negative (96% sensitivity), that is, 1 participant who was rated as much or very much improved on the CGI was not classified as a responder on the BDD-YBOCS using the 30% threshold.
次要结局
- Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)(12 weeks, 1 month post treatment)
- Appearance Anxiety Inventory (AAI)(12 weeks, 1 month post treatment)
- Body Image Quality of Life Inventory (BIQLI)(12 weeks, 1 month post treatment)
- Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).(12 weeks, 1 month post treatment)
- Patient Health Questionnaire (PHQ)-9(12 weeks, 1 month post treatment)
- Generalised Anxiety Disorder (GAD)-7(12 weeks,1 month post treatment)
研究者
David Veale
Consultant Psychiatrist
Institute of Psychiatry, London