Functional Rehabilitation of Older Patients With Schizophrenia
March 23, 2015 updated by: US Department of Veterans Affairs
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92161
- VA San Diego Healthcare System, San Diego
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: ARM 1
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.
|
|
ACTIVE_COMPARATOR: ARM 2
Goal Focused Supportive Contact (GFSC)
|
Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Independent Living Skills Survey (ILSS)
Time Frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comprehensive Module Test (CMT)
Time Frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
|
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.
|
baseline, mid-treatment, end of treatment, mid-follow up, and follow up
|
|
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Time Frame: baseline, mid-treatment, end of treatment, mid follow-up, and followup
|
The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms.
Positive symptoms are rated on 7 domains: Delusions, Conceptual Disorganization, Hallucinatory Behavior, Excitement, Grandiosity, Suspiciousness/Persecution, and Hostility.
Each domain in the positive symptom subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity).
Total scores of the seven domains are summed to yield a total score range of 0 (Absence) to 49 (Extreme), where higher scores represent more severe positive symptoms.
|
baseline, mid-treatment, end of treatment, mid follow-up, and followup
|
|
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
Time Frame: baseline, mid treatment, end of treatment, mid follow-up, and follow up
|
The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms.
The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia.
Each item is rated from 0 (Absent) to 5 (Severe).
The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13).
|
baseline, mid treatment, end of treatment, mid follow-up, and follow up
|
|
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
Time Frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
|
The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms.
There are 9 items that measure diminished motivation which consists of two domains: Avolition-Apathy and Anhedonia-Asociality.
Each item is rated from 0 (Absent) to 5 (Severe).
The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #17 and #22).
|
baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
|
|
Beck Depression Inventory-II (BDI-II)
Time Frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
|
The BDI-II is a self-report measure of depression that consists of 21 questions.
The total scale ranges from 0-63.
Scores from individual questions are summed to yield a total score.
Higher scores represent greater severity of depression.
|
baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
|
|
Beck Anxiety Inventory (BAI)
Time Frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow up
|
The Beck Anxiety Inventory is a self-report measure of anxiety that consists of 21 questions.
Scores from individual items are summed to yield a total score.
The total score ranges from 0-63.
Higher scores represent greater severity of anxiety.
|
baseline, mid-treatment, end of treatment, mid follow-up, and follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eric L. Granholm, PhD, VA San Diego Healthcare System, San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (ACTUAL)
January 1, 2009
Study Completion (ACTUAL)
January 1, 2009
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (ESTIMATE)
October 12, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
April 6, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- O3341-R
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