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Functional Rehabilitation for Older Patients With Schizophrenia (FROPS)

This study has been terminated.
(Loss of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00712075
First Posted: July 9, 2008
Last Update Posted: June 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: April 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Aging
Interventions: Behavioral: CBSST+PDA
Behavioral: Cognitive Behavioral Social Skills Training
Behavioral: PDA-only

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants included 77 community dwelling Veterans and non-Veterans. Inclusion criteria: diagnosis of schizophrenia or schizoaffective, age 45 or older, fluency in English, and medical, psychiatric and substance abuse sufficiently stable for outpatient group therapy Exclusion criteria: prior exposure to CBT during the previous five years.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
107 participants were enrolled in the study and 77 participants started the study. 30 were excluded (lost interest, N=6; Wrong diagnosis, N=10; Early study termination, N=4; Medically unstable, N=2; Psychiatrically unstable, N=4; Prior CBT, N=4).

Reporting Groups
  Description
CBSST+PDA

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.

CBSST+PDA: 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.

CBSST

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.

Cognitive Behavioral Social Skills Training: 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.

PDA-Only

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.

PDA-only: 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.


Participant Flow:   Overall Study
    CBSST+PDA   CBSST   PDA-Only
STARTED   22   30   25 
COMPLETED   17   26   14 
NOT COMPLETED   5   4   11 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CBSST+PDA

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.

CBSST+PDA: 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.

CBSST

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.

Cognitive Behavioral Social Skills Training: 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.

PDA-Only

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.

PDA-only: 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.

Total Total of all reporting groups

Baseline Measures
   CBSST+PDA   CBSST   PDA-Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   26   14   57 
Age, Customized 
[Units: Participants]
       
Age 45 and older   17   26   14   57 
Gender 
[Units: Participants]
       
Female   1   8   1   10 
Male   16   18   13   47 
Region of Enrollment 
[Units: Participants]
       
United States   17   26   14   57 


  Outcome Measures
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1.  Primary:   Independent Living Skills Survey (ILSS)   [ Time Frame: Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline) ]

2.  Secondary:   Comprehensive Module Test (CMT)   [ Time Frame: Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline) ]

3.  Secondary:   Positive and Negative Syndrome Scale (PANSS)   [ Time Frame: Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Eric Granholm, PhD
Organization: VA San Diego Healthcare System, San Diego
phone: 858-552-8585 ext 7768
e-mail: egranholm@ucsd.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00712075     History of Changes
Other Study ID Numbers: E4876-R
First Submitted: July 3, 2008
First Posted: July 9, 2008
Results First Submitted: April 15, 2015
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015