Cost-Effectiveness of Adding Web-Based CBT to Luvox CR for OCD
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome measure (Y-BOCS score) will be obtained by clinician rating
研究概览
简要总结
This study will test the hypotheses that: 1. 12 weeks of Luvox-CR plus web-based Cognitive-Behavioral Therapy (CBT) [CT-STEPS] will produce greater symptom relief of OCD than treatment with Luvox-CR alone; and, 2. subjects receiving 12 weeks of CT-STEPS added to Luvox-CR treatment after 12-weeks of Luvox-CR monotherapy will experience greater OCD symptom relief (from weeks 12-24) than those continuing Luvox-CR treatment and having access to CT-STEPS from week one. 3. subjects who begin CT-STEPS at week 12 will be more likely to complete it than those who begin CT-STEPS at baseline.
详细描述
Primary Endpoint(s): Change in Y-BOCS score from baseline to endpoint at weeks 12 and 24; and, number (and percent) "responders" at weeks 12 and 24, defined as subjects with a 35% decrease in Y-BOCS score at endpoint and a Clinical Global Impressions score of 1 or 2 (very much or much improved).
Secondary Endpoint(s):
- change in scores on the Work and Social Adjustment Scale, a quality of life measure
- change in scores on the Work Productivity and Activity Impairment
Questionnaire:
Specific Health Problem scale; in particular, we will analyze change in work hours/week lost because of OCD, and change in effect of OCD on work productivity (0-10 scale). 3. dollar cost per responder 4. dollar cost per total number of patients needed to produce one additional responder in the Luvox-CR plus web-based CBT group over the number produced by Luvox-CR alone, i.e., dollar cost per number needed to treat 5. dollar cost per 5% decrease in Y-BOCS score at weeks 12 and 24 in the two treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 years, with OCD of at least 1 year's duration, meeting DSM-IV diagnostic criteria, and having a baseline Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of 18.
排除标准
- •Pregnant or nursing women or women of childbearing age not using an effective contraceptive method
- •Organic mental disorder
- •Bipolar disorder
- •Psychotic disorder
- •History of substance abuse or dependence within 3 years of evaluation for study
- •Major depression with suicidal risk
- •Major depression dominating the clinical picture
- •Panic disorder
- •Personality disorder severe enough to interfere with cooperation with study procedures
- •Need for antipsychotic medication
- •Depot neuroleptic drug within 6 months
- •Fluoxetine within 5 weeks
- •An MAOI within 2 weeks, any nightly sedative, or taking a medication that may interact with fluvoxamine
- •Serious or unstable medical condition (hematological, endocrine, cardiovascular, renal or gastrointestinal), a history of malignancy (other than excised basal cell carcinoma), history of brain disease, including more than one childhood febrile convulsion and all forms of epilepsy; or, are receiving behavior therapy for OCD.
- •Subjects who qualify for the study while taking an SSRI must have been taking their current dose or a higher dose for at least 12 weeks prior to study baseline.
- •Subjects who qualify for the study while taking fluvoxamine must be taking no more than 150 mg/day and never had a trial at a higher dose, must be believed by the investigator to be able to tolerate an increase to 250 mg/day starting at baseline, and must have been taking their pre-study dose or a higher dose (up to 150 mg/day) for at least 12 weeks prior to study baseline.
研究组 & 干预措施
A
Effectiveness of Luvox CR plus Web-based CBT for OCD
干预措施: Luvox CR (Drug)
A
Effectiveness of Luvox CR plus Web-based CBT for OCD
干预措施: Behavioral Therapy (Behavioral)
结局指标
主要结局
The primary outcome measure (Y-BOCS score) will be obtained by clinician rating
时间窗: screening, baseline, and end of weeks 4, 8, 12, 16, 20 and 24.
次要结局
未报告次要终点