Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00712075
First received: July 3, 2008
Last updated: January 11, 2011
Last verified: January 2011

July 3, 2008
January 11, 2011
July 2008
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00712075 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Functional Rehabilitation for Older Patients With Schizophrenia
Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Aging
  • Behavioral: Computer-Assisted Cognitive Behavioral Social Skills Training
    There will be 24 weekly group therapy sessions, each 90 minutes 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. Participants will utilize Palm PDAs to assist in homework completion and compliance.
    Other Name: CBSST+PDA
  • Behavioral: Cognitive Behavioral Social Skills Training
    There will be 24 weekly group therapy sessions, each 2.5 hours (30 min lunch break) 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.
    Other Name: CBSST
  • Behavioral: PDA-only comparator group
    To control for the effects of having a PDA, the third group will be provided with PDAs for the same duration as the other two groups. Participants will have access to the same functions (calendar, contact list, etc.) as the CBSST+PDA group, but will not have any homework or weekly group meetings.
    Other Name: PDA-only
  • Experimental: 1
    Computer-Assisted (PDA) Cognitive-Behavioral Social Skills Training (CBSST)
    Intervention: Behavioral: Computer-Assisted Cognitive Behavioral Social Skills Training
  • Active Comparator: 2
    Cognitive Behavioral Social Skills Training (CBSST)
    Intervention: Behavioral: Cognitive Behavioral Social Skills Training
  • Active Comparator: 3
    PDA-only
    Intervention: Behavioral: PDA-only comparator group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Schizophrenia or Schizoaffective Disorder and age >50

Exclusion Criteria:

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

Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00712075
E4876R
Yes
Granholm, Eric - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Eric L. Granholm, PhD VA San Diego Healthcare System, San Diego
Department of Veterans Affairs
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP