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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CBSST plus treatment as usual
Treatment as usual (TAU)
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Late-life schizophrenia (LLS), Cognitive Behavioural Social Skills Training (CBSST), Randomized

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBSST plus treatment as usual

Treatment as Usual Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Efficacy of CBSST in improving social function

Secondary Outcome Measures

Full Information

First Posted
January 29, 2009
Last Updated
February 16, 2021
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT00832845
Brief Title
Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study
Acronym
CBSST
Official Title
Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Late-life schizophrenia (LLS), Cognitive Behavioural Social Skills Training (CBSST), Randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBSST plus treatment as usual
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBSST plus treatment as usual
Intervention Description
Patients will receive CBSST in addition to their regular treatment for 36 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of CBSST in improving social function
Time Frame
At termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C. Mamo, MD, MSc
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek Rajji, MD, FRCPC
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34896870
Citation
Rajji TK, Mamo DC, Holden J, Granholm E, Mulsant BH. Cognitive-Behavioral Social Skills Training for patients with late-life schizophrenia and the moderating effect of executive dysfunction. Schizophr Res. 2022 Jan;239:160-167. doi: 10.1016/j.schres.2021.11.051. Epub 2021 Dec 9. Erratum In: Schizophr Res. 2023 Jun;256:136.
Results Reference
derived
PubMed Identifier
28297590
Citation
Gerretsen P, Voineskos AN, Graff-Guerrero A, Menon M, Pollock BG, Mamo DC, Mulsant BH, Rajji TK. Insight Into Illness and Cognition in Schizophrenia in Earlier and Later Life. J Clin Psychiatry. 2017 Apr;78(4):e390-e397. doi: 10.4088/JCP.16m10741.
Results Reference
derived
Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre.

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

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