跳至主要内容
临床试验/NCT00712075
NCT00712075终止不适用

Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2008年7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
终止
入组人数
107
试验地点
1
主要终点
Independent Living Skills Survey (ILSS)

研究概览

简要总结

Aging and psychosis are major priority areas for VA. This project is a continuation of a Merit Review Program, in which we developed, manualized and conducted randomized controlled trials of a novel psychosocial rehabilitation intervention for older people with schizophrenia, called cognitive-behavioral social skills training (CBSST). We found that CBSST improved community functioning in these patients. CBSST, however, is an intensive program that would burden VA mental health clinics with demands for additional staff and financial resources and burdens older veterans with travel and time demands. To reduce these burdens and barriers to implementation of CBSST, we are developing a computer-assisted CBSST intervention that takes advantage of available handheld computer technology. Therapist contact is cut 50% and replaced by handheld computer-assisted CBSST intervention tools. The project will examine whether computer-assisted CBSST is as effective as the full CBSST program, while improving client satisfaction and reducing burden and cost.

详细描述

Aging and psychosis are major priority areas for VA. This project is a continuation of a Merit Review Program, in which we developed, manualized and conducted randomized controlled trials of a novel psychosocial rehabilitation intervention for older people with schizophrenia, called cognitive-behavioral social skills training (CBSST). We found that CBSST improved community functioning in these patients. CBSST, however, is an intensive program that may burden VA mental health clinics with demands for additional staff and financial resources and Veterans with travel and time demands. To reduce these burdens and barriers to implementation of CBSST, we developed a computer-assisted CBSST intervention that takes advantage of available handheld computer technology (personal data assistants or PDAs). Therapist contact is cut 50% and replaced by handheld computer-assisted CBSST intervention tools. The project will examine whether computer-assisted CBSST is as effective as the full CBSST program, while improving client satisfaction and reducing burden and cost. A randomized-controlled clinical trial comparing 3 treatment conditions (computer-assisted CBSST, CBSST, and a PDA-only control condition) will be conducted. Participants will be recruited, treated for 6 months and followed longitudinally for 6 months after treatment. A multidimensional evaluation of treatment outcome, including functioning (primary outcome), CBSST skills acquisition, and symptoms will be conducted at baseline, mid-treatment, end of treatment (6-months after baseline), and 6-month follow-up (12 months after baseline). Factors that might mediate improvement in CBSST will be assessed, including homework adherence, cognitive insight (metacognition and belief flexibility), and defeatist performance beliefs (e.g., "Why try, I'll just fail again").

The proposed project will also use innovative computer-assisted Ecological Momentary Assessment (EMAc) methods to measure outcomes. EMAc is an ambulatory data collection technique that permits the real time, real world monitoring of behaviors, moods, and cognitions. Participants are signaled by handheld computers several times throughout the day to respond to questionnaires, which eliminates recall and information-processing biases that can compromise the validity of traditional self-report and interview measures. Outcomes in the proposed trial will be assessed using traditional measures, as well as EMAc measures.

Specific Aims: (1) To determine whether computer-assisted CBSST is as effective as the full CBSST program (in prior project) and supportive contact, despite reduced burden and cost. (2) To examine whether EMAc measures of functioning and psychotic symptoms are sensitive to change in CBSST. (3) To examine whether increased cognitive insight, reduced defeatist performance beliefs, and greater homework adherence mediate outcomes in CBSST.

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
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Schizophrenia or Schizoaffective Disorder and age >45 (Veterans and non-Veterans)
  • •fluency in English
  • •Medical, psychiatric and substance abuse sufficiently stable for outpatient group therapy

排除标准

  • •prior exposure to CBST during the previous 5 years

研究组 & 干预措施

CBSST+PDA

Experimental

PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.

干预措施: CBSST+PDA (Behavioral)

CBSST

Active Comparator

Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.

干预措施: Cognitive Behavioral Social Skills Training (Behavioral)

PDA-Only

Active Comparator

PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.

干预措施: PDA-only (Behavioral)

结局指标

主要结局

Independent Living Skills Survey (ILSS)

时间窗: Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)

The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent a higher level of functioning.

次要结局

  • Positive and Negative Syndrome Scale (PANSS)(Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline))
  • Comprehensive Module Test (CMT)(Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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