Effectiveness of IPT Adapted for Depressed Women With Trauma Histories in a Community Mental Health Center
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module
研究概览
简要总结
The aim of the Women's Depression Treatment Study, based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS) on improving depression and other psychological and social functioning. IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.
详细描述
Evidence-based treatments for depression have rarely been studied in community settings where low-income and ethnic minority patients receive care. Among the most in need of effective treatments are depressed women with histories of early interpersonal trauma, who suffer disproportionate burden characterized by chronic depression, multiple comorbidities, and marked interpersonal difficulties. The aim of this randomized controlled trial (RCT), based in a community mental health center, is to evaluate the effectiveness of Interpersonal Psychotherapy-Trauma in Community Settings (IPT-TCS). IPT-TCS is Interpersonal Psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. This trial (n=180) will compare IPT-TCS to active treatment as usual (TAU) for women with major depression and histories of childhood sexual abuse. We hypothesize that IPT-TCS will be more effective than TAU in reducing depression at 32-weeks after treatment assignment. Improvements in social functioning, health-related functioning, post-traumatic stress symptoms, and mental health functioning are also expected. To monitor post-treatment course, outcome variables will be assessed at 6-month intervals over a 2-year period, and longer-term effects will be examined via repeated-measure analyses. This trial is designed to provide definitive results regarding the effectiveness of IPT-TCS compared to usual care in a community mental health center.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Current Major Depression
- •History of sexual abuse prior to age 18
排除标准
- •Bipolar disorder
- •Psychosis or schizophrenia
- •Active alcohol or substance abuse
结局指标
主要结局
Structured Clinical Interview for DSM-IV diagnoses: Current Major Depression Module
时间窗: 20 months
次要结局
- Beck Depression Inventory(20 months)
- Hamilton Rating Scale for Depression(20 months)
研究者
Nancy Talbot
Associate Professor, Department of Psychiatry
University of Rochester
