Clinical trial NCT00237796: Functional Rehabilitation of Older Patients With Schizophrenia
Official title: Functional Rehabilitation of Older Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Schizoaffective Disorder
Schizophrenia
Keywords: Behavioral
Cognitive
Functioning
Older
CBT
Rehabilitation
Schizophrenia
Skills
Social
Training
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-10-12
Enrollment: 116
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Independent Living Skills Survey (ILSS)
timeFrame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
Secondary outcomes:
measure: Comprehensive Module Test (CMT)
timeFrame: baseline, mid-treatment, end of treatment, mid-follow up, and follow up
measure: Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
timeFrame: baseline, mid-treatment, end of treatment, mid follow-up, and followup
measure: Scale for the Assessment of Negative Symptoms (SANS) - Diminished Expression
timeFrame: baseline, mid treatment, end of treatment, mid follow-up, and follow up
measure: The Scale for the Assessment of Negative Symptoms (SANS) - Diminished Motivation
timeFrame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: baseline, mid-treatment, end of treatment, mid follow-up, and follow-up
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline, mid-treatment, end of treatment, mid follow-up, and follow up
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego
name: Eric L. Granholm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.