Functional Rehabilitation of Older Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00237796
First received: October 7, 2005
Last updated: August 20, 2009
Last verified: August 2009

October 7, 2005
August 20, 2009
February 2005
January 2009   (final data collection date for primary outcome measure)
ILSS [ Time Frame: baseline, end of treatment, follow-up ] [ Designated as safety issue: No ]
  • Social functioning (at baseline)
  • End of treatment (9-month follow-up)
  • 9-month post-treatment (18-month follow-up)
  • Additionally, at mid-treatment (4.5 month)
Complete list of historical versions of study NCT00237796 on ClinicalTrials.gov Archive Site
Not Provided
Neuropsychological functioning, cognitive insight, psychotic symptoms, and health services utilization, will be conducted at baseline, end of treatment (9-month follow-up), and 9-month post-treatment (18-month follow-up).
Not Provided
Not Provided
 
Functional Rehabilitation of Older Patients With Schizophrenia
Functional Rehabilitation of Older Patients With Schizophrenia

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Psychotic Disorders
  • Schizoaffective Disorder
  • Schizophrenia
  • Behavioral: Cognitive Behavioral Social Skills Training
    Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
  • Behavioral: Goal Directed Supportive Care Contact
    Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
  • Experimental: 1
    CBSST
    Intervention: Behavioral: Cognitive Behavioral Social Skills Training
  • Active Comparator: 2
    Goal Directed Supportive Care
    Intervention: Behavioral: Goal Directed Supportive Care Contact

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
January 2009
January 2009   (final data collection date for primary outcome measure)

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

Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00237796
O3341R
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
August 2009

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