Functional Rehabilitation for Older Patients With Schizophrenia

NCT00712075 | Terminated Results DMC

• 1 other identifier: E4876-R
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Aging

Keywords

Cognitive Behavioral Therapy; Social Skills Training; Experience Sampling Method; Computer-assisted therapy; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Independent Living Skills Survey (ILSS)

  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 a higher level of functioning.

  Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)

Secondary Outcomes (2)

• Comprehensive Module Test (CMT)

  Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)

• Positive and Negative Syndrome Scale (PANSS)

  Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)

Study Arms (3)

CBSST+PDA

EXPERIMENTAL

PDA-Assisted Cognitive-Behavioral Social Skills Training (CBSST+PDA): The CBSST rehabilitation intervention will be combined with the use of a PDA to facilitate homework completion and progress towards recovery goal attainment in consumers.

Behavioral: CBSST+PDA

CBSST

ACTIVE COMPARATOR

Cognitive Behavioral Social Skills Training (CBSST): CBSST is a psychosocial rehabilitation intervention that combines skills from cognitive behavioral therapy and social skills training to assist consumers in improving functioning and recovery goal attainment.

Behavioral: Cognitive Behavioral Social Skills Training

PDA-Only

ACTIVE COMPARATOR

PDA-only: To control of device contact, the PDA-only arm will not receive CBSST and will only carry a PDA with access to the basic features of the device.

Behavioral: PDA-only

Interventions

CBSST+PDA BEHAVIORAL

PDA-Assisted Cognitive Behavioral Social Skills Training (CBSST+PDA) includes weekly group therapy sessions, each 90 minutes in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis. Participants utilized PDAs to assist with homework completion and compliance.

Also known as: PDA-Assisted Cognitive Behavioral Social Skills Training

CBSST+PDA

Cognitive Behavioral Social Skills Training BEHAVIORAL

Cognitive Behavioral Social Skills Training includes weekly group therapy sessions, each 2.5 hours (30 min lunch break) in length, with 6-8 patients (maximum of 10) were held for 24 weeks. The intervention integrated cognitive behavioral and social skills training interventions modified for use with older patients with psychosis.

Also known as: CBSST

CBSST

PDA-only BEHAVIORAL

To control for the effects of having a PDA, a third group was provided PDAs for the same duration as the other two groups. Participants had access to the same basic functions (calendar, contact list, etc.) as the CBSST+PDA group, but did not have any homework or weekly group meetings.

PDA-Only

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Schizophrenia or Schizoaffective Disorder and age \>45 (Veterans and non-Veterans)
• fluency in English
• Medical, psychiatric and substance abuse sufficiently stable for outpatient group therapy

You may not qualify if:

• prior exposure to CBST during the previous 5 years

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

Early termination leading to small sample size and loss of follow-up data. No 50% CBSST comparison group without mobile computer to test efficacy of shorter treatment alone.

Results Point of Contact

• Title: Eric Granholm, PhD
• Organization: VA San Diego Healthcare System, San Diego

egranholm@ucsd.edu

858-552-8585

Study Officials

• Eric L. Granholm, PhD

  VA San Diego Healthcare System, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 1, 2015
• Results First Posted: June 1, 2015

Record last verified: 2015-05

Locations

US (1)