Combined Treatment for Generalized Anxiety Disorder (GAD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Rating Scale (HAM-A)
研究概览
简要总结
The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the current study are to conduct a late stage treatment development study. The goal of this stage of research is to provide a preliminary answer to the question and to gather data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) that would assist in planning further research.
详细描述
The specific aims of this study are to collect preliminary data relevant to the following hypotheses:
- Primary Hypothesis: Acute phase improvement for combined cognitive behavioral therapy (CBT) plus medication will be superior to medication alone.
- Secondary Hypotheses: Combined CBT plus medication will be superior to medication alone on a number of secondary outcome measures, including the core feature of GAD (worry), depressive symptoms, functional impairment, and quality of life.
- Additional Exploratory Aim: We will explore the comparative relapse rates for the combined CBT plus medication treatment and the medication alone treatment condition at 6-month follow-up.
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
- None
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
- •GAD diagnosis by structured interview
- •Hamilton Anxiety Scale score of 18 or less
- •Clinical Global Impressions Scale score of at least 4
- •Hamilton Depression Scale score of 18 or less
- •Hamilton Depression Scale suicide item score less than 2
- •Use of an effective form of contraception throughout the s
排除标准
- •Hypersensitivity to venlafaxine XR
- •History of seizures
- •Episode of major depressive disorder in the previous 6 months
- •History of any psychotic illness, bipolar disorder, or dementia
- •Substance abuse and dependence during the past 6 months
- •Other anxiety disorders with the exception of social phobia as long as GAD is primary
- •Regular use of anxiolytics or antidepressants within 7 days of study onset
- •Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)
- •Use of other psychotic medication besides benzodiazepines
研究组 & 干预措施
Combined Treatment
Patients who receive combined cognitive behavioral therapy (CBT) plus medication (venlafaxine XR, flexibly dosed between 75-225 mg/day) treatment for GAD. CBT was once/week sessions for 12 weeks. Medication continued for the full 6 months.
干预措施: Cognitive Behavioral Therapy (Behavioral)
Combined Treatment
Patients who receive combined cognitive behavioral therapy (CBT) plus medication (venlafaxine XR, flexibly dosed between 75-225 mg/day) treatment for GAD. CBT was once/week sessions for 12 weeks. Medication continued for the full 6 months.
干预措施: Venlafaxine XR (Drug)
Venlafaxine XR 75-225 mg alone
These patients receive only medication treatment for GAD. Patients take venlafaxine (flexibly dosed from 75-225 mg/day) as part of NCT00183274 and are assessed over a 6 month period. Medication continued for the full 6 months.
干预措施: Venlafaxine XR (Drug)
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
The HAM-A was used to measure the severity of anxiety symptoms. The scale consists of 14 items; each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate and 25-30 moderate to severe anxiety. This measure was conducted by research psychiatrists trained and highly experienced in the use of these scales. The evaluators were blind to group assignment.
次要结局
- Hospital Anxiety Depression Scale (HAD)-Depression Score(Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24)
- Clinical Global Impression (CGI)-Severity Score(Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24)
- Clinical Global Impression (CGI)-Improvement Score(Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24)
- Clinical Response Rate(Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24)
- Hospital Anxiety Depression Scale (HAD)-Anxiety Score(Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24)
- Hamilton Rating Scale for Depression (HAM-D)-17-item Score(Data collected as part of protocol 709012 at baseline, week 12, and week 24)
- Penn State Worry Questionnaire (PSWQ)(Data collected as part of protocol 709012 at baseline, week 12, and week 24)
- Physical Component Score of the 12-Item Short Form Survey (SF-12)(Data collected as part of protocol 709012 at baseline, week 12, and week 24)
- Quality of Life Subscale of the General Health Questionnaire (GHQ)(Data collected as part of protocol 709012 at baseline, week 12, and week 24)
- Mental Component Score of the 12-item Short Form Survey (SF-12)(Data collected as part of protocol 709012 at baseline, week 12, and week 24)
- 50 Percent or Greater Reduction in PSWQ Score(Data collected as part of protocol 709012 at baseline, week 12, and week 24)
研究者
Paul Crits-Christoph
Professor of Psychology in Psychiatry
University of Pennsylvania