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Clinical Trials/NCT00237796
NCT00237796
Completed
N/A

Functional Rehabilitation of Older Patients With Schizophrenia

US Department of Veterans Affairs1 site in 1 country116 target enrollmentFebruary 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychotic Disorders
Sponsor
US Department of Veterans Affairs
Enrollment
116
Locations
1
Primary Endpoint
Independent Living Skills Survey (ILSS)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The primary purpose of this project is to evaluate the efficacy of a group therapy intervention, cognitive behavioral social skills training (CBSST), that teaches social functioning skills and cognitive-behavioral compensatory aids to older patients with schizophrenia. CBSST, therefore, targets the multidimensional deficits that lead to disability in aging veterans with severe mental illness.

Detailed Description

This is a randomized-controlled clinical trial comparing 2 treatment conditions: Goal focused supportive care (SC); and CBSST. Subjects (N=100) will be recruited, treated for 9 months and followed longitudinally for 9 months after treatment. A multidimensional evaluation of treatment outcome, including social functioning (primary outcome), neuropsychological functioning, cognitive insight, psychotic symptoms, and health services utilization, will be conducted at baseline, end of treatment (9-month follow-up), and 9 months post-treatment. 100 patients with schizophrenia or schizoaffective disorder will participate on a voluntary basis and will be paid $50.00 per assessment visit. Subjects will not be paid or given any incentive for treatment. The following inclusion/exclusion criteria will be used: (i) Voluntary informed consent for participation (given by the patient or conservator); (ii) Age 45 or older; (iii) DSM-IV-diagnosis (APA, 1994) of schizophrenia or schizoaffective disorder at any stage of illness; (iv) No prior exposure to SST or CBT in the past 5 years; (v) Level of care required at baseline does not interfere with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric, or physical illness). We anticipate that we will be able to provide an empirically validated intervention that can be used by clinicians on multidisciplinary rehabilitation teams to reduce disability in aging patients with schizophrenia. The products from this research will be written research reports and a therapy manual and patient workbook to guide rehabilitation that can be disseminated (e.g., via the internet) to relevant clinicians.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
January 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 45 years of age and older
  • DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder
  • Fluent in speaking, reading, and writing English
  • Physically and psychiatrically stable enough to undergo various assessments in this study

Exclusion Criteria

  • Has not received Cognitive Behavioral Therapy (CBT) or Social Skills Training (SST) or Dialectical Behavioral Therapy (DBT) in the past 5 years

Outcomes

Primary Outcomes

Independent Living Skills Survey (ILSS)

Time Frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up

The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent higher level of functioning.

Secondary Outcomes

  • Beck Anxiety Inventory (BAI)(baseline, mid-treatment, end of treatment, mid follow-up, and follow up)
  • Comprehensive Module Test (CMT)(baseline, mid-treatment, end of treatment, mid-follow up, and follow up)
  • Positive and Negative Syndrome Scale (PANSS) - Positive Subscale(baseline, mid-treatment, end of treatment, mid follow-up, and followup)
  • The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation(baseline, mid-treatment, end of treatment, mid follow-up, and follow-up)
  • Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression(baseline, mid treatment, end of treatment, mid follow-up, and follow up)
  • Beck Depression Inventory-II (BDI-II)(baseline, mid-treatment, end of treatment, mid follow-up, and follow-up)

Study Sites (1)

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