Functional Rehabilitation of Older Patients With Schizophrenia
1 other identifier
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
April 6, 2015
CompletedApril 6, 2015
March 1, 2015
3.9 years
October 7, 2005
November 19, 2014
March 23, 2015
Conditions
Keywords
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 higher level of functioning.
baseline, mid-treatment, end of treatment, mid-follow up, and follow up
Secondary Outcomes (6)
Comprehensive Module Test (CMT)
baseline, mid-treatment, end of treatment, mid-follow up, and follow up
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
baseline, mid-treatment, end of treatment, mid follow-up, and followup
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
baseline, mid treatment, end of treatment, mid follow-up, and follow up
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
Beck Depression Inventory-II (BDI-II)
baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
- +1 more secondary outcomes
Study Arms (2)
ARM 1
EXPERIMENTALCognitive Behavioral Social Skills Training (CBSST)
ARM 2
ACTIVE COMPARATORGoal Focused Supportive Contact (GFSC)
Interventions
Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Has not received Cognitive Behavioral Therapy (CBT) or Social Skills Training (SST) or Dialectical Behavioral Therapy (DBT) in the past 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego
San Diego, California, 92161, United States
Related Publications (1)
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.
PMID: 23395192RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
* Randomization of treatment groups were not matched on the primary outcome (ILSS) at baseline but this was controlled using baseline ILSS as a covariate. * Participant dropout varied across assessments
Results Point of Contact
- Title
- Eric Granholm, PhD
- Organization
- VA San Diego Healthcare System, San Diego
Study Officials
- PRINCIPAL INVESTIGATOR
Eric L. Granholm, PhD
VA San Diego Healthcare System, San Diego
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
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
October 7, 2005
First Posted
October 12, 2005
Study Start
February 1, 2005
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
April 6, 2015
Results First Posted
April 6, 2015
Record last verified: 2015-03