Functional Rehabilitation of Older Patients With Schizophrenia

• ClinicalTrials.gov Identifier: NCT00237796
• Recruitment Status: Completed
• First Posted: October 12, 2005
• Results First Posted: April 6, 2015
• Last Update Posted: April 6, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

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.

Condition or disease	Intervention/treatment	Phase
Psychotic Disorders; Schizoaffective Disorder; Schizophrenia	Behavioral: Cognitive Behavioral Social Skills Training (CBSST); Behavioral: Goal Focused Supportive Contact (GFSC)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Functional Rehabilitation of Older Patients With Schizophrenia
• Study Start Date: February 2005
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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).
4. 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).
5. 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.
6. 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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

VA San Diego Healthcare System, San Diego

San Diego, California, United States, 92161

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

• Principal Investigator: Eric L. Granholm, PhD; VA San Diego Healthcare System, San Diego

More Information

Publications of Results:

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.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00237796
• Other Study ID Numbers: O3341-R
• First Posted: October 12, 2005
• Results First Posted: April 6, 2015
• Last Update Posted: April 6, 2015
• Last Verified: March 2015

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):

Behavioral; Cognitive; Functioning; Older; CBT; Rehabilitation; Schizophrenia; Skills; Social; Training

Additional relevant MeSH terms:

Disease; Schizophrenia; Psychotic Disorders; Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders