Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study (CBSST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00832845|
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : February 17, 2021
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.
Previous studies show that cognitive deficits are strong predictors of response to CBSST. Cognitive Remediation Treatments (CRTs) have been shown to improve cognition in patients with schizophrenia especially when combined with psychosocial interventions that focus on function such as CBSST. Thus, we also propose to assess the tolerability and impact of CRT on patients with late-life schizophrenia.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: CBSST plus treatment as usual Behavioral: Treatment as usual (TAU)||Not Applicable|
Eighty subjects will be randomized into 2 arms, CBSST Group and Treatment as Usual Group. Both Arms will run for a total of 52 weeks. The CBSST Group will attend 2-hour weekly sessions for 9 months and attend follow up assessments every 4 months. The Treatment as Usual Group will continue with their normal psychiatric treatment as usual and also attend follow up assessments every 4 months. After subjects in the Treatment as Usual Arm finish, they will continue on to the CBSST Group arm.
After the completion of the CBSST Group Arm, 24 subjects who are willing to consent to CRT will continue with an additional 2-hour weekly session of Cognitive Remediation Treatment for 8 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: CBSST plus treatment as usual
Subject randomized to the CBSST Group arm will attend 2 hour weekly Cognitive Behavioural Social Skills therapy sessions for 9 months. They will also be attending follow-up assessments q 4 months.
Behavioral: CBSST plus treatment as usual
Patients will receive CBSST in addition to their regular treatment for 36 weeks.
Active Comparator: Treatment as Usual Group
Subjects randomized to the Treatment as Usual Group Arm will continue with their regular psychiatric treatment for 1 year. Like the CBSST Group Arm, they will have follow up assessments q 4 months. After completing the Treatment as Usual Group arm, they will automatically continue on with the CBSST Group Arm.
Behavioral: Treatment as usual (TAU)
Patients will receive their regular treatment for 36 weeks without CBSST. TAU consists of the standard care that patients receive, including routine visits and contacts with their physicians and clinicians.
- Efficacy of CBSST in improving social function [ Time Frame: At termination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832845
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M6J 1H4|
|Principal Investigator:||David C. Mamo, MD, MSc||Centre for Addiction and Mental Health|
|Principal Investigator:||Tarek Rajji, MD, FRCPC||Centre for Addiction and Mental Health|