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Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, September 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00712075
  Purpose

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.


Condition Intervention
Schizophrenia
Aging
Behavioral: Computer-Assisted Cognitive Behavioral Social Skills Training
Behavioral: Goal-Focused Supportive Contact

MedlinePlus related topics: Rehabilitation Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Independent Living Skills Survey [ Time Frame: Baseline, end treatment (6-mos) and 6-mo follow-up (12 mos post-baseline) ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: July 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Computer-Assisted Cognitive-Behavioral Social Skills Training (CBSST)
Behavioral: Computer-Assisted Cognitive Behavioral Social Skills Training
There will be 24 weekly group therapy sessions, each one hour in length, with 6-8 patients (maximum of 10). The intervention integrates cognitive behavioral and social skills training interventions modified for use with older patients with psychosis.
2: Active Comparator
Goal-focused supportive contact
Behavioral: Goal-Focused Supportive Contact
Patients will set treatment goals in a supportive contact setting and use handheld computers that will signal them three times per day to ask questions about current context, mood and activities, and will offer to play computer games for up to 10 minutes. As in computer-assisted CBSST, weekly one-hour sessions will be delivered for 24 weeks.

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 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. A randomized-controlled clinical trial comparing 2 treatment conditions: Computer-assisted CBSST, and a computer-assisted Supportive Contact (SC) control condition will be conducted. Subjects (N=108) 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, symptoms, health services utilization, and preliminary cost analysis will be conducted at baseline, 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Schizophrenia or Schizoaffective Disorder and age >50

Exclusion Criteria:

Medical, psychiatric and substance abuse sufficiently stable for outpatient group therapy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712075

Contacts
Contact: Sherry Edwards, BA (858) 552-8585 ext 2275 sedwards@ucsd.edu
Contact: Cathy Loh, PhD (858) 552-8585 ext 1265 cathy.loh@va.gov

Locations
United States, California
VA San Diego Healthcare System, San Diego Recruiting
San Diego, California, United States, 92161
Contact: Cathy Loh, PhD     858-552-8585 ext 1265     cathy.loh@va.gov    
Contact: Sherry Edwards, BA     (858) 552-8585 ext 2275     sedwards@ucsd.edu    
Principal Investigator: Eric L. Granholm, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Eric L. Granholm, PhD VA San Diego Healthcare System, San Diego
  More Information

Publications of Results:
Responsible Party: Department of Veterans Affairs ( Granholm, Eric - Principal Investigator )
Study ID Numbers: E4876R
Study First Received: July 3, 2008
Last Updated: September 16, 2008
ClinicalTrials.gov Identifier: NCT00712075  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cognitive Behavioral Therapy
Social Skills Training
Experience Sampling Method
Computer-assisted therapy
schizophrenia

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 14, 2009