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Clinical Trials/NCT00712075
NCT00712075
Terminated
Not Applicable

Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)

US Department of Veterans Affairs1 site in 1 country107 target enrollmentJuly 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
US Department of Veterans Affairs
Enrollment
107
Locations
1
Primary Endpoint
Independent Living Skills Survey (ILSS)
Status
Terminated
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
November 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • prior exposure to CBST during the previous 5 years

Outcomes

Primary Outcomes

Independent Living Skills Survey (ILSS)

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (1)

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