Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)
研究概览
简要总结
The efficacy of two forms of psychotherapy with panic disordered patients, a cognitive-behavioral and a psychodynamic one, are compared under two different, randomized conditions: randomization or self-selection. The basic hypotheses are that the efficacy of both treatments is higher and that the efficacy difference is smaller under self-selection than randomized conditions.
详细描述
After thorough assessment persons with a panic disorder diagnosis are randomly assigned to three arms: one randomization, one self-selection, and one a low-contact waiting list one. In the randomization arm (R) 95 persons are randomly assigned to Panic Control Treatment (PCT) or Panic-Focused Psychodynamic Psychotherapy (PFPP); in the self-selection arm (SS) 95 persons are offered, after adequate information, to choose which of the two they prefer. Twenty-six persons are initially randomized to a three-month waiting list (with sparse contact over telephone), after which they will be re-randomized, either to further randomization (to PCT or PFPP) or to self-selection. The four groups (R/PCT; R/PFPP; SS/PCT; SS/PFPP) will be compared on the basis of intake and repeated outcome/follow-up assessment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A Diagnostic and Statistical Manual (DSM-V) diagnosis of Panic Disorder, with or without Agoraphobia
- •Age between 18 and 60
- •Willingness to stop other on-going psychotherapy treatments and to refrain from nonstudy treatments during follow up
- •Ability to complete the active treatment phase (not including follow-ups) within 16 weeks
排除标准
- •Active substance dependence (6 months remission necessary)
- •Current psychosis, delusions, mania, or active addiction
- •Acute suicidality
- •A history and clinical presentation of at least one clinically-significant medical condition if, due to their cognitive or physical impairments, they are unable to fully participate in the psychotherapy treatments being offered
- •Active involvement in a legal dispute related to their mental health issues
- •Three or more unexcused absences
结局指标
主要结局
Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)
时间窗: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in occupational status
时间窗: Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination
Change in absence from work due to sickness
时间窗: Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination
次要结局
- Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985)(Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination)
- Change in health care utilization (number of medical contacts, and emergency visits, medication)(Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination)
- Change on Clinical Outcomes in Routine Evaluation Scale(CORE; Evans et al., 2000)(Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination)
- Change on Montgomery Asberg Depression Rating Scale (MADRS-S; Montgomery & Asberg, 1979)(Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination)