A Controlled Trial of Cognitive-Behavioral Therapy as an Adjunct to Serotonin Reuptake Inhibitors in Body Dysmorphic Disorder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Body Dysmorphic Disorder Examination
研究概览
简要总结
The research project is a controlled pilot study of the efficacy of cognitive-behavioral therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to relaxation and stress management training (RSMT), an active control treatment
详细描述
In total, 20 BDD patients aged 16 through 65 will participate. To be eligible they must meet DSM-IV criteria for BDD, have a score of 20 or greater on the BDD modification of the Yale Brown Obsessive-Compulsive Scale (BDD-YBOCS) and be on a stable, therapeutic does of an SRI (at least 12 weeks on the SRI with 8 weeks at a therapeutic dose: acceptable medications (therapeutic daily doses) are citalopram (40mg), clomipramine (150mg), fluoxetine (40mg), fluvoxamine (150mg), paroxetine (40mg), sertraline (50mg), and venlafaxine (150mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-65
- •A diagnosis of DSM-IV BDD or its delusional variant (delusional disorder, somatic type)
- •Ability to communicate meaningfully with the investigators
- •Competent to provide written consent, if over 18 years old, or competent to provide written assent, if 16-17 years, 11 months
- •Parental consent, if under 18 years old
- •For phase two: must be on a stable therapeutic dose of one of the following SRI medications for at least 8 weeks: fluoxetine, fluvoxamine, venlafaxine, clomipramine, paroxetine, citalopram, or sertraline.
排除标准
- •current or lifetime diagnosis of any DSM_IV psychotic disorder not attributable to delusional BDD, current or lifetime diagnosis of DSM-IV bipolar disorder,
- •current or recent (within 2 months of study entry) DSM-IV alcohol or substance dependence or abuse,
- •recent suicide attempt, or suicidal ideation that warrants consideration of hospitalization,
- •need for inpatient or partial hospital treatment,
- •use of any medication prescribed for the treatment of BDD other than SRIs, including tricyclic antidepressants, buspirone, or neuroleptics,
- •presence of any significant and/or unstable medical condition,
- •females who are pregnant or breast-feeding, or who are sexually active and not using adequate contraception.
研究组 & 干预措施
Body dysmorphic disorder
Participants with body dysmorphic disorder
干预措施: Cognitive Behavioral Therapy (Behavioral)
Body dysmorphic disorder
Participants with body dysmorphic disorder
干预措施: Venlafaxine (Drug)
结局指标
主要结局
Body Dysmorphic Disorder Examination
时间窗: baseline and up to 16 weeks
Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180.
Yale Brown Obsessive Scale
时间窗: baseline and up to 16 weeks
Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) - a 12-item semistructured clinician-rated instrument designed to rate severity of body dysmorphic disorder (BDD) symptoms during the past week. The score for each item ranges from 0 (no symptoms) to 4 (extreme symptoms). The BDD-YBOCS Obsession Subtotal score range is 0-20 and the BDD-YBOCS Compulsion Subtotal score range is 0-20. The BDD-YBOCS Insight/Avoidance Subtotal score range is 0-8. The total BDD-YBOCS score range is from 0 (not present or extremely mild) to 48 (severe). Each item is rated as a composite of all the patient's appearance related obsessions and compulsive behaviors independent of their content.
Body Dysmorphic Disorder Clinical Global Impressions Scale
时间窗: baseline and up to 16 weeks
The Clinical Global Impression-Improvement Scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
次要结局
- Beck Anxiety Inventory(Baseline and up to 16 weeks)
- Brown Assessment of Beliefs Scale(Baseline and up to 16 weeks)
- Beck Depression Inventory II(Baseline and up to 16 weeks)