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临床试验/NCT02069873
NCT02069873已完成不适用

Phase II Efficacy Study on Group Delivery of Effective Treatments for PTSD

New Mexico VA Healthcare System1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2008年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later.

研究概览

简要总结

The purpose of the study is to evaluate the efficacy of a group protocol for the delivery of evidence-based therapies in comparison to a wait-list control and evaluate the relative contribution of exposure, cognitive, and skills blocks of treatment in a 16-session manualized group treatment protocol in a sample of OIF/OEF female PTSD veterans. Hyp1: Overall improvement is expected in PTSD symptoms compared to a wait-list control group; and Hyp2: the exposure and cognitive components are expected to show greater improvement in PTSD symptoms than the skills component. Significant results will establish the efficacy of a group format for evidence-based treatments for all veterans with a PTSD diagnosis. An ancillary part of the study is to examine initial neuropsychological presentation in this population and possible changes that may occur as the result of treatment.

详细描述

OBJECTIVES: The objectives are to 1) evaluate the effectiveness of exposure, cognitive, and skills (assertiveness/relaxation) therapies within a 16-session group; and 2) evaluate the relative contribution of each of three treatment components in a manualized treatment group in a sample of OIF/OEF female PTSD veterans. HYPOTHESES: Hypothesis 1. Female OIF/OEF PTSD veterans will show reductions in PTSD symptoms and improvement in general functioning after participation in a structured group treatment compared to a wait-list control group. Hypothesis 2. Exposure and cognitive components will show greater improvement in PTSD symptoms than the skills component. RESEARCH DESIGN/BACKGROUND: Based on studies with male combat veterans, female civilian rape victims, and female veterans, therapies most effective for Posttraumatic Stress Disorder (PTSD) are exposure therapy (1,2,3) and cognitive restructuring (4), with less improvement found in other treatments, such as relaxation and assertiveness training (5). Most examinations of PTSD treatments have been conducted in an individual format, but most PTSD treatments offered in Veterans Administration (VA) hospital PTSD programs are conducted in a group format (6). It is critical to determine if these therapies work in a group setting, as only one study (7) found no differences in exposure therapy compared to a support group. In a comprehensive manualized group treatment protocol (8) exposure therapy provided in a group was found effective (9). The aim of the present study is to establish the effectiveness of exposure therapy, among other evidence-based therapies, in a well designed randomized study. METHODOLOGY: Castillo's (8) manualized group treatment protocol for female veterans with PTSD will be modified into a 16-week treatment group with a five-week exposure, five-week cognitive, and four-week skills treatment blocks. Seventy-two subjects will be assessed with structured interviews (SCID and CAPS) and questionnaires (Traumatic Life Events and Quality of Life Inventory) and randomized into one of two arms: 16-week immediate treatment, or a 16-week wait-list control, the latter of which will be reassessed and offered the study treatment. Oversampling will result in 72 subjects in the active treatment arm. Subjects will be reassessed upon completion of treatment or wait-list, at 3, and 6 months following treatment. All treatment groups will include three female OIF/OEF veterans positive for PTSD. The treatment blocks will be varied into six possible orders to control for order effects and the PTSD Symptom Checklist will be administered after each treatment block. Data will be collected for three years. CLINICAL RELATIONSHIPS: Significant results will contribute to the establishment of evidence-based treatments in a manualized treatment group for all veterans with a PTSD diagnosis. FINDINGS: Present findings from Dr. Castillo's lab suggest the effectiveness of exposure therapy in a group setting.

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
19 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Diagnosis of PTSD
  • •Iraq or Afghanistan female Veteran
  • •Psychiatry stability (no suicide, homicide)
  • •One clear memory of a trauma
  • •Stability on psychiatric medications for 1 month

排除标准

  • •Active substance use/abuse (or in remission less than 3 mo)
  • •Psychotic symptoms or diagnosis
  • •Bipolar disorder diagnosis
  • •Cognitive impairment
  • •Involvement in a violent relationship
  • •Self mutilation within past 6 months

研究组 & 干预措施

16-Week Group Treatment

Experimental

The 16-week treatment group will contain 3 blocks of treatment (exposure, cognitive, skills) with order randomized within the treatment. The first and last group session are considered inactive treatment sessions. The group treatment will be provided weekly.

干预措施: 16-Week Group Treatment (Behavioral)

Wait List Control

No Intervention

The Wait List Control group will receive minimal attention, as they will meet bi-monthly for supportive sessions with the study psychologist. The study psychologist will not introduce any active treatment in the individual sessions.

结局指标

主要结局

Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later.

时间窗: Baseline, post-treatment, 3 months follow up, 6 months follow up.

Interview administration of the CAPS by independent assessor captures current (past month) and lifetime symptoms and diagnosis of Post-Traumatic Stress Disorder (PTSD).

次要结局

  • Change in mental and physical functioning from baseline on the Health Related Quality of Life (SF36) to post-treatment, 3 months, and 6 months later.(Baseline, post-treatment, 3-month follow up, 6-month follow up)
  • Change in quality of life from baseline on the Quality of Life Inventory (QOLI) to post-treatment, 3 months, and 6 months later.(Baseline, post-treatment, 3-month follow up, 6-month follow up)
  • Change in PTSD from baseline to points during treatment with the PTSD Symptom Checklist (PCL).(Baseline, after each treatment block (every 5 weeks), post-treatment)

研究者

发起方
New Mexico VA Healthcare System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Diane T. Castillo, Ph.D.

Supervisory Psychologist

New Mexico VA Healthcare System

研究点 (1)

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