Schizophrenia Clinical Trial
Official title:
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 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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