Randomized Controlled Trial Examining the Effectiveness of Two Group Psychotherapies for Anxiety Disorders: Unified Cognitive-behavioral Therapy vs. Combined Cognitive Behavioral and Dance/Movement Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Hamilton Anxiety Rating Scale
研究概览
简要总结
The current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy.
In addition, change in proposed mechanism in each therapy will be examined, along with their association with change in outcome measures during therapy.
详细描述
The current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy.
24 patients will be randomized to 1 of the two treatment arms and treated with 20 weekly 1.5-2 hours therapy sessions. Independent evaluator and self-reports measures will be collected at intake, pre-treatment, session by session, post-treatment and and follow-up.
Hypotheses:
- Both groups will show effectiveness, as revealed by reduction in anxiety severity and increase in valued living.
- Changes in process measures (proposed mechanism of change - emotion regulation, working alliance, fear of bodily sensations, bodily/movement awareness) will be predictive of change in outcome measures (anxiety severity and valued living).
- Changes in bodily/movement awareness will be more predictive of change in outcome measures in the CBT-DMT group than in the unified protocol group.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One of the following primary axis I DSM-IV-TR diagnoses: Panic disorder with or without Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder; Anxiety Disorder Not Otherwise Specified; Adjustment Disorder With Anxiety; Adjustment Disorder With Mixed Anxiety and Depressed Mood
- •If on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase of the study (5-6 months)
- •Provision of written informed consent
排除标准
- •Current or past schizophrenia, psychosis, or bipolar disorder.
- •Current suicidal ideation.
- •Current substance/alcohol dependence or abuse.
- •Cluster A or B personality disorder.
- •Pregnancy (for women).
结局指标
主要结局
Change in Hamilton Anxiety Rating Scale
时间窗: Intake (entry to study), Pre-treatment (1 month from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
Structured independent evaluator interview for assessing severity of anxiety
次要结局
- Change in Depression, Anxiety, Stress Scales-21(Intake (entry to study), Weekly during treatment (weekly between 1-6 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake))
- Change in Valued Living Questionnaire(Intake (entry to study), Pre-treatment (1 month from intake), Mid-Treatment (3.5 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake))
- Change in Mini International Neuropsychiatric Interview(Intake (entry to study), Pre-treatment (1 month from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake))