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Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study (CBSST)

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ClinicalTrials.gov Identifier: NCT00832845
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : April 13, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

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
Schizophrenia Behavioral: CBSST plus treatment as usual Behavioral: Treatment as usual (TAU)

Detailed Description:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study
Study Start Date : June 2008
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 24 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 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.

Outcome Measures

Primary Outcome Measures :
  1. Efficacy of CBSST in improving social function [ Time Frame: At termination ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4
Sponsors and Collaborators
Centre for Addiction and Mental Health
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
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tarek Rajji, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00832845     History of Changes
Other Study ID Numbers: 066/2008
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tarek Rajji, Centre for Addiction and Mental Health:
Late-life schizophrenia (LLS)
Cognitive Behavioural Social Skills Training (CBSST)

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders