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

February 16, 2021 updated by: Tarek Rajji, Centre for Addiction and Mental Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of CBSST in improving social function
Time Frame: At termination
At termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 066/2008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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