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

NCT00832845 | Completed

• 1 other identifier: 066/2008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Late-life schizophrenia (LLS); Cognitive Behavioural Social Skills Training (CBSST); Randomized

Outcome Measures

Primary Outcomes (1)

• Efficacy of CBSST in improving social function

  At termination

Study Arms (2)

CBSST plus treatment as usual

EXPERIMENTAL

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

Treatment as Usual Group

ACTIVE COMPARATOR

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)

Interventions

CBSST plus treatment as usual BEHAVIORAL

Patients will receive CBSST in addition to their regular treatment for 36 weeks.

CBSST plus treatment as usual

Treatment as usual (TAU) BEHAVIORAL

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.

Treatment as Usual Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (2)

• 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.

  PMID: 34896870 DERIVED

• 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.

  PMID: 28297590 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• David C. Mamo, MD, MSc

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Tarek Rajji, MD, FRCPC

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: June 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)