Desensitization and Cognitive Therapy in General Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- High End State Function
研究概览
简要总结
This study will evaluate the effectiveness of three adaptive coping treatments in lessening anxiety in adults with generalized anxiety disorder.
详细描述
Generalized anxiety disorder (GAD) is a common psychiatric disorder that affects nearly 6.8 million adults in the United States. GAD is characterized by persistent feelings of worry and anxiety that remain even when there is little reason for concern. The excessive worry that people with GAD experience can be so extreme that carrying out activities of daily life becomes difficult. GAD is often accompanied by physical symptoms as well, including muscle aches, nausea, sweating, exhaustion, irritability, frequent urination, and shaking. People with GAD are also at a higher risk for other disorders, including depression and substance abuse, making early treatment of GAD important. Forms of psychotherapy that concentrate on stress management, relaxation techniques, and control of thoughts about anxiety-provoking situations may be effective treatments for people with GAD. This study will evaluate the effectiveness of three adaptive coping treatments, relaxation and self-control desensitization, cognitive behavioral therapy (CBT), and a combination of the two, in lessening anxiety in adults with GAD.
Participation in this study will last about 28 months. All participants will first complete three assessment sessions that will include an interview about anxiety symptoms and medical history, self-report questionnaires, and a physiological evaluation. After the first interview, participants will be asked to rate their level of anxiety four times a day in a diary. They will continue with these daily diary entries through the completion of treatment. Once participants complete the first 2 weeks' worth of daily ratings, participants will be assigned randomly to receive treatment with relaxation and self-control desensitization, CBT, or a combination of the two treatments. All participants will receive 14 weekly treatment sessions lasting between 1.5 and 2 hours each. During CBT sessions, participants will learn to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Between sessions, all participants will complete homework assignments that will involve practicing the approaches learned in sessions and continuing the daily diaries.
Upon completion of treatment, participants will repeat the initial assessments. Follow-up visits will occur at Months 6, 12, and 24 after treatment completion and will include repeat interview and self-report sessions and completion of 1 week's worth of daily diary entries before each visit.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of GAD
排除标准
- •Diagnosis of any of the following: panic disorder, subclinical GAD, severe depression, psychosis, or organic brain syndrome
- •Currently receiving therapy for GAD or has previously received CBT
- •Medical contributions to anxiety
- •Currently taking antidepressant medication
- •Current substance abuse
研究组 & 干预措施
Purely Behavioral therapy
Participants will receive treatment with progressive and applied relaxation and self-control desensitization.
干预措施: Applied relaxation and self-control desensitization (Behavioral)
Cognitive-Behavioral Therapy
Participants will receive treatment with cognitive therapy, progressive and applied relaxation, and self-control desensitization
干预措施: Cognitive-Behavioral Therapy (Behavioral)
Cognitive Therapy (CT)
Participants will receive purely cognitive therapy including identification of maladaptive thought processes and training in cognitive restructuring.
干预措施: Cognitive therapy (CT) (Other)
结局指标
主要结局
High End State Function
时间窗: 10-14 days after last therapy session and months 6, 12, and 24 following last therapy session
Percentage of participants meeting high end state functioning (e.g., within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire)
次要结局
- Within-group Change Represented as Cohen's d Effect Sizes(10-14 days after last therapy session and months 6, 12, and 24 following last therapy session)
研究者
Michelle G. Newman
Study Director
Penn State University
