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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00712075 |
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 |
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Schizophrenia Aging |
Behavioral: Computer-Assisted Cognitive Behavioral Social Skills Training Behavioral: Goal-Focused Supportive Contact |
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) |
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 |
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1: Experimental
Computer-Assisted Cognitive-Behavioral Social Skills Training (CBSST)
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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.
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2: Active Comparator
Goal-focused supportive contact
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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.
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Schizophrenia or Schizoaffective Disorder and age >50
Exclusion Criteria:
Medical, psychiatric and substance abuse sufficiently stable for outpatient group therapy
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 |
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 |
Principal Investigator: | Eric L. Granholm, PhD | VA San Diego Healthcare System, San Diego |
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 |
Cognitive Behavioral Therapy Social Skills Training Experience Sampling Method Computer-assisted therapy schizophrenia |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |