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
  Purpose

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.


Condition Intervention
Psychotic Disorders
Schizoaffective Disorder
Schizophrenia
Behavioral: Cognitive Behavioral Social Skills Training
Behavioral: Goal Directed Supportive Care Contact

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 of Older Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • ILSS [ Time Frame: baseline, end of treatment, follow-up ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: February 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CBSST
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.
Active Comparator: 2
Goal Directed Supportive Care
Behavioral: Goal Directed Supportive Care Contact
Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  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: NCT00237796

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Granholm, Eric - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00237796     History of Changes
Other Study ID Numbers: O3341R
Study First Received: October 7, 2005
Last Updated: August 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Behavioral
Cognitive
Functioning
Older
CBT
Rehabilitation
Schizophrenia
Skills
Social
Training

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

ClinicalTrials.gov processed this record on August 21, 2014