Functional Rehabilitation of Older Patients With Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Functional Rehabilitation of Older Patients With Schizophrenia

Conditions
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Psychotic Disorders, Schizoaffective Disorder, Schizophrenia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Social Skills Training (CBSST)
* Behavioral: Goal Focused Supportive Contact (GFSC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM 1<br>Cognitive Behavioral Social Skills Training (CBSST) | Behavioral: Cognitive Behavioral Social Skills Training (CBSST)<br>* Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.<br>|
| Active Comparator: ARM 2<br>Goal Focused Supportive Contact (GFSC) | Behavioral: Goal Focused Supportive Contact (GFSC)<br>* Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, mid-treatment, end of treatment, mid-follow up, and follow up | 
| 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. | baseline, mid-treatment, end of treatment, mid follow-up, and followup | 
| 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). | baseline, mid treatment, end of treatment, mid follow-up, and follow up | 
| 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). | baseline, mid-treatment, end of treatment, mid follow-up, and follow-up | 
| 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. | baseline, mid-treatment, end of treatment, mid follow-up, and follow-up | 
| 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. | baseline, mid-treatment, end of treatment, mid follow-up, and follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral, Cognitive, Functioning, Older, CBT, Rehabilitation, Schizophrenia, Skills, Social, Training