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Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)

Primary Purpose

Schizophrenia, Aging

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBSST+PDA
Cognitive Behavioral Social Skills Training
PDA-only
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive Behavioral Therapy, Social Skills Training, Experience Sampling Method, Computer-assisted therapy, schizophrenia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • prior exposure to CBST during the previous 5 years

Sites / Locations

  • VA San Diego Healthcare System, San Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CBSST+PDA

CBSST

PDA-Only

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comprehensive Module Test (CMT)
The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.
Positive and Negative Syndrome Scale (PANSS)
The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.

Full Information

First Posted
July 3, 2008
Last Updated
May 12, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00712075
Brief Title
Functional Rehabilitation for Older Patients With Schizophrenia
Acronym
FROPS
Official Title
Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Loss of funding
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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 may burden VA mental health clinics with demands for additional staff and financial resources and Veterans with travel and time demands. To reduce these burdens and barriers to implementation of CBSST, we developed a computer-assisted CBSST intervention that takes advantage of available handheld computer technology (personal data assistants or PDAs). 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. A randomized-controlled clinical trial comparing 3 treatment conditions (computer-assisted CBSST, CBSST, and a PDA-only control condition) will be conducted. Participants will be recruited, treated for 6 months and followed longitudinally for 6 months after treatment. A multidimensional evaluation of treatment outcome, including functioning (primary outcome), CBSST skills acquisition, and symptoms will be conducted at baseline, mid-treatment, end of treatment (6-months after baseline), and 6-month follow-up (12 months after baseline). Factors that might mediate improvement in CBSST will be assessed, including homework adherence, cognitive insight (metacognition and belief flexibility), and defeatist performance beliefs (e.g., "Why try, I'll just fail again"). The proposed project will also use innovative computer-assisted Ecological Momentary Assessment (EMAc) methods to measure outcomes. EMAc is an ambulatory data collection technique that permits the real time, real world monitoring of behaviors, moods, and cognitions. Participants are signaled by handheld computers several times throughout the day to respond to questionnaires, which eliminates recall and information-processing biases that can compromise the validity of traditional self-report and interview measures. Outcomes in the proposed trial will be assessed using traditional measures, as well as EMAc measures. Specific Aims: (1) To determine whether computer-assisted CBSST is as effective as the full CBSST program (in prior project) and supportive contact, despite reduced burden and cost. (2) To examine whether EMAc measures of functioning and psychotic symptoms are sensitive to change in CBSST. (3) To examine whether increased cognitive insight, reduced defeatist performance beliefs, and greater homework adherence mediate outcomes in CBSST.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Aging
Keywords
Cognitive Behavioral Therapy, Social Skills Training, Experience Sampling Method, Computer-assisted therapy, schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBSST+PDA
Arm Type
Experimental
Arm Description
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.
Arm Title
CBSST
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PDA-Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBSST+PDA
Other Intervention Name(s)
PDA-Assisted Cognitive Behavioral Social Skills Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Social Skills Training
Other Intervention Name(s)
CBSST
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PDA-only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Independent Living Skills Survey (ILSS)
Description
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.
Time Frame
Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)
Secondary Outcome Measure Information:
Title
Comprehensive Module Test (CMT)
Description
The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.
Time Frame
Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)
Title
Positive and Negative Syndrome Scale (PANSS)
Description
The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.
Time Frame
Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: prior exposure to CBST during the previous 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L. Granholm, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Functional Rehabilitation for Older Patients With Schizophrenia

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