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
  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: Cognitive Behavioral Social Skills Training
Behavioral: PDA-only comparator group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)

Resource links provided by NLM:


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 ]

Enrollment: 99
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Computer-Assisted (PDA) Cognitive-Behavioral Social Skills Training (CBSST)
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
Active Comparator: 2
Cognitive Behavioral Social Skills Training (CBSST)
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
Active Comparator: 3
PDA-only
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

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:   45 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Eric L. Granholm, PhD VA San Diego Healthcare System, San Diego
  More Information

No publications provided

Responsible Party: Granholm, Eric - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00712075     History of Changes
Other Study ID Numbers: E4876R
Study First Received: July 3, 2008
Last Updated: January 11, 2011
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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014