Functional Rehabilitation of Older Patients With Schizophrenia
Primary Purpose
Psychotic Disorders, Schizoaffective Disorder, Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Social Skills Training (CBSST)
Goal Focused Supportive Contact (GFSC)
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring Behavioral, Cognitive, Functioning, Older, CBT, Rehabilitation, Schizophrenia, Skills, Social, Training
Eligibility Criteria
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
Sites / Locations
- VA San Diego Healthcare System, San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ARM 1
ARM 2
Arm Description
Cognitive Behavioral Social Skills Training (CBSST)
Goal Focused Supportive Contact (GFSC)
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 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) - Positive Subscale
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.
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
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).
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
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).
Beck Depression Inventory-II (BDI-II)
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.
Beck Anxiety Inventory (BAI)
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.
Full Information
NCT ID
NCT00237796
First Posted
October 7, 2005
Last Updated
March 23, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00237796
Brief Title
Functional Rehabilitation of Older Patients With Schizophrenia
Official Title
Functional Rehabilitation of Older Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizoaffective Disorder, Schizophrenia
Keywords
Behavioral, Cognitive, Functioning, Older, CBT, Rehabilitation, Schizophrenia, Skills, Social, Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARM 1
Arm Type
Experimental
Arm Description
Cognitive Behavioral Social Skills Training (CBSST)
Arm Title
ARM 2
Arm Type
Active Comparator
Arm Description
Goal Focused Supportive Contact (GFSC)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Social Skills Training (CBSST)
Intervention Description
Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
Intervention Type
Behavioral
Intervention Name(s)
Goal Focused Supportive Contact (GFSC)
Intervention Description
Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
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 higher level of functioning.
Time Frame
baseline, mid-treatment, end of treatment, mid-follow up, and follow up
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, mid-treatment, end of treatment, mid-follow up, and follow up
Title
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Description
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.
Time Frame
baseline, mid-treatment, end of treatment, mid follow-up, and followup
Title
Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
Description
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).
Time Frame
baseline, mid treatment, end of treatment, mid follow-up, and follow up
Title
The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
Description
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).
Time Frame
baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
baseline, mid-treatment, end of treatment, mid follow-up, and follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Citations:
PubMed Identifier
23395192
Citation
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.
Results Reference
result
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Functional Rehabilitation of Older Patients With Schizophrenia
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