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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tarek Rajji, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00832845
First received: January 29, 2009
Last updated: March 26, 2014
Last verified: March 2014
  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Social Skills Training for Patients With Late-Life Schizophrenia: a Pilot Study

Resource links provided by NLM:


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: 80
Study Start Date: June 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

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
Study First Received: January 29, 2009
Last Updated: March 26, 2014
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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014