Functional Rehabilitation of Older Patients With Schizophrenia

NCT ID: NCT00237796

Last Updated: 2015-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2009-01-31

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.

Conditions

Psychotic Disorders; Schizoaffective Disorder; Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ARM 1

Cognitive Behavioral Social Skills Training (CBSST)

Group Type: EXPERIMENTAL

Cognitive Behavioral Social Skills Training (CBSST)

Intervention Type: BEHAVIORAL

Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.

ARM 2

Goal Focused Supportive Contact (GFSC)

Group Type: ACTIVE_COMPARATOR

Goal Focused Supportive Contact (GFSC)

Intervention Type: BEHAVIORAL

Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.

Interventions

Cognitive Behavioral Social Skills Training (CBSST)

Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.

Intervention Type: BEHAVIORAL

Goal Focused Supportive Contact (GFSC)

Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric L. Granholm, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego

Locations

VA San Diego Healthcare System, San Diego

San Diego, California, United States

Countries

United States

References

Granholm E, Holden J, Link PC, McQuaid JR, Jeste DV. Randomized controlled trial of cognitive behavioral social skills training for older consumers with schizophrenia: defeatist performance attitudes and functional outcome. Am J Geriatr Psychiatry. 2013 Mar;21(3):251-62. doi: 10.1016/j.jagp.2012.10.014. Epub 2013 Jan 10.

Reference Type: RESULT

PMID: 23395192 (View on PubMed)

Other Identifiers

O3341-R

Identifier Type: -

Identifier Source: org_study_id