Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia - Full Text View

Sponsored by:	Centre for Addiction and Mental Health
Information provided by:	Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:	NCT00832845

Purpose

Schizophrenia is associated with significant cognitive and functional deficits. As patients with schizophrenia grow older, the impact of these deficits at a personal and public health level is likely to increase. Cognitive Behavioral and Social Skills Training (CBSST) is a recently developed group therapy that increased the frequency of social activities among middle-aged patients with schizophrenia. It also increased cognitive insight, a measure of the ability to reduce confidence in aberrant beliefs. To date, CBSST has not been studied in late-life schizophrenia. In addition, its impact on medications management, an instrumental function that is particularly salient in late life, and its interactions with cognition are largely unknown. Thus, we propose to study the efficacy of CBSST in improving social skills and medications management in patients with late-life schizophrenia, and to study the interactions between the patients' cognitive characteristics and their response to CBSST.

Condition	Intervention
Schizophrenia	Behavioral: Cognitive Behavioral Social Skills Training (CBSST) plus treatment as usual Behavioral: Treatment as usual (TAU)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Mental Health Schizophrenia

U.S. FDA Resources

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:

Efficacy of CBSST in improving social function [ Time Frame: At termination ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Cognitive Behavioral Social Skills Training (CBSST) plus treatment as usual Patients will receive CBSST in addition to their regular treatment for 24 weeks.
2: Active Comparator	Behavioral: Treatment as usual (TAU) Patients will receive their regular treatment for 24 weeks without CBSST. TAU consists of the standard care that patients receive, including routine visits and contacts with their physicians and clinicians. However, in addition to the standard of care, subjects receiving TAU will have 24 weekly 60-minute non-structured meetings, including half-hour lunch break, to control for non-specific factors associated with group therapy.

Arms

Assigned Interventions

1: Experimental

Behavioral: Cognitive Behavioral Social Skills Training (CBSST) plus treatment as usual

Patients will receive CBSST in addition to their regular treatment for 24 weeks.

2: Active Comparator

Behavioral: Treatment as usual (TAU)

Patients will receive their regular treatment for 24 weeks without CBSST. TAU consists of the standard care that patients receive, including routine visits and contacts with their physicians and clinicians. However, in addition to the standard of care, subjects receiving TAU will have 24 weekly 60-minute non-structured meetings, including half-hour lunch break, to control for non-specific factors associated with group therapy.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 60 years and above.
All races and ethnicities.
Females and males.
Meets DSM-IV TR criteria for a current diagnosis of schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or psychotic disorder NOS.
Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in antipsychotic medication dosage within the 4 weeks prior to assessment, and (3) and ascertained to be clinically stable by one the study psychiatrists.
Willingness and ability to speak English
Willingness to provide informed consent
Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.

Exclusion Criteria:

Meets criteria for a cognitive disorder secondary to a neurological or other medical disorder affecting the ability to participate in CBSST.
Diagnosis of bipolar disorder or current major depressive episode.
Meets diagnostic criteria for substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine.
Electroconvulsive Therapy (ECT) within 6 months of initial assessment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832845

Contacts

Contact: David C. Mamo, MD, MSc

416-535-8501 ext 7532

David_Mamo@camh.net

Locations

Canada, Ontario
Centre for Addiction and Mental Health	Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: David C. Mamo, MD MSc 416-535-8501 ext 7532 David_Mamo@camh.net
Principal Investigator: David C. Mamo, MD, MSc
Sub-Investigator: Benoit H. Mulsant, MD, MSc
Sub-Investigator: Bruce G. Pollock, MD, PhD
Sub-Investigator: Tarek K. Rajji, MD

Sponsors and Collaborators

Centre for Addiction and Mental Health

Investigators

Principal Investigator:

David C. Mamo, MD, MSc

Centre for Addiction and Mental Health

More Information

Additional Information:

Information about research at the Centre for Addiction and Mental Health This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Centre for Addiction and Mental Health ( David Mamo, MD MSc )
Study ID Numbers:	066/2008
Study First Received:	January 29, 2009
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00832845 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:

Late-life schizophrenia (LLS)
Cognitive Behavioural Social Skills Training (CBSST)
Randomized

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 28, 2009