Functional Rehabilitation of Older Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00237796
First received: October 7, 2005
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Psychotic Disorders
Schizoaffective Disorder
Schizophrenia
Behavioral: Cognitive Behavioral Social Skills Training (CBSST)
Behavioral: Goal Focused Supportive Contact (GFSC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Rehabilitation of Older Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Independent Living Skills Survey (ILSS) [ Time Frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, mid-treatment, end of treatment, mid follow-up, and followup ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, mid treatment, end of treatment, mid follow-up, and follow up ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, mid-treatment, end of treatment, mid follow-up, and follow up ] [ Designated as safety issue: No ]
    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.


Enrollment: 116
Study Start Date: February 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM 1
Cognitive Behavioral Social Skills Training (CBSST)
Behavioral: 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)
Behavioral: Goal Focused Supportive Contact (GFSC)
Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237796

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Eric L. Granholm, PhD VA San Diego Healthcare System, San Diego
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00237796     History of Changes
Other Study ID Numbers: O3341-R
Study First Received: October 7, 2005
Results First Received: November 19, 2014
Last Updated: March 23, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Behavioral
Cognitive
Functioning
Older
CBT
Rehabilitation
Schizophrenia
Skills
Social
Training

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on April 19, 2015