跳至主要内容
临床试验/NCT00688259
NCT00688259已完成不适用

Cognitive-Behavioral Therapy in Veterans With Schizophrenia

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2009年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
2
主要终点
Changes in Positive Schizophrenia Symptoms

研究概览

简要总结

This is a study comparing the benefits of two types of individual psychotherapy (cognitive-behavioral therapy for psychosis and supportive therapy) in symptomatic Veteran outpatients diagnosed with schizophrenia or schizoaffective disorder. Treatment lasted approximately 6 months, with outcome data on symptoms, functioning, and distress levels collected at baseline, post-treatment, and 6 months post -treatment follow-up.

详细描述

This is a randomized controlled trial comparing 6 months of participation in one of two active treatments, cognitive-behavioral therapy for psychosis or supportive therapy in symptomatic Veterans diagnosed with schizophrenia or schizoaffective disorder who are still symptomatic. Assessments of clinical status and social functioning were obtained at baseline, end of treatment, and 6 month follow-up. We hypothesized that participation in the cognitive-behavioral therapy would lead to greater reductions in symptoms and distress about symptoms, and more improvements in social functioning.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • outpatients with schizophrenia or schizoaffective disorder in proximity to the West Los Angeles VAMC
  • at least one month since last hospitalization
  • stable antipsychotic medication with persisting psychotic symptoms with at least minimal distress
  • competent to sign informed consent.

排除标准

  • in other individual psychotherapy
  • presence of organic brain disease
  • mental retardation
  • illness that would prohibit regular attendance in therapy
  • substance dependence diagnosis in the past 6 months.

研究组 & 干预措施

Cognitive Behavioral Therapy for Psychosis (CBTp)

Experimental

approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.

干预措施: Cognitive Behavioral Therapy for Psychosis (CBTp) (Behavioral)

Supportive Therapy (ST)

Active Comparator

approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' lives and concerns

干预措施: Supportive Therapy (ST) (Behavioral)

结局指标

主要结局

Changes in Positive Schizophrenia Symptoms

时间窗: Pre-treatment to follow-up, approximately 6 months post end-of-treatment

Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, \& Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243

Changes in Global Social Functioning

时间窗: Pre-treatment to follow-up, approximately 6 months post end-of-treatment

Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler N, Hogarty G, Weissman M:, 1979) with low scores indicating better functioning Schooler N, Hogarty G,\& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303)

次要结局

  • Changes in Distress From Schizophrenia Symptoms(Pre-treatment to follow-up, approximately 6 months post end-of-treatment)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Cognitive-Behavioral Therapy in Veterans With... | 临床试验