Cognitive Remediation Therapy for Participants With Late-Life Schizophrenia

NCT03695614 | Completed

• 1 other identifier: 083/2017
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive Remediation (CR) involving restorative and strategy-based methods has been previously validated in a pilot study for late life schizophrenia (LLS), where CR demonstrated a moderate effect on overall cognition. This study proposes to study the efficacy of CR in a larger cohort of participants with LLS and to assess the interaction of medication management with CR on cognitive outcomes. Eligible participants will receive CR during 12 weeks. CR consists of a series of computerized exercises targeting various cognitive functions, such as memory, attention and processing speed. It will be administered during facilitated group sessions consisting of 4-6 people. The study will recruit 40 participants with the aim to enroll 30 LLS participants age 55 or older who will undergo the CR intervention for two, 2-hour weekly classes over 12 weeks (24 classes in total). There will be baseline assessments (clinical and NP) prior to enrollment in the classes. In order to assess whether there has been a change in cognition, and some of the assessments will be repeated after the 12-week intervention.

Conditions

Schizophrenia; Cognitive Remediation; Late Life Schizophrenia; Functional Impairment; Cognitive Deficit

Outcome Measures

Primary Outcomes (1)

• Assess the effect of CR on cognitive performance as indicated by total Montreal Cognitive Assessment (MoCA) scores

  Total score out of 30 possible points, with 30/30 indicating best possible score

  approximately 12 weeks after the baseline

Secondary Outcomes (9)

• Assess effect of Cognitive Remediation (CR) on tolerability of CR according to the percentage of participants completing the 12-week course

  approximately 12 weeks after the baseline

• Change in general, positive, and negative symptoms of Schizophrenia as assessed by the Positive and Negative Syndrome Scale

  At baseline and approximately 12 weeks after the baseline

• Change in depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia

  At baseline and approximately 12 weeks after the baseline

• Change in visuospatial/executive domains of cognition as assessed by the Trail making Test B and A

  At baseline and approximately 12 weeks after the baseline

• Change in immediate memory, visuospatial/constructional cognition, language, attention, and delayed memory as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  At baseline and approximately 12 weeks after the baseline

Study Arms (1)

Cognitive Remediation

EXPERIMENTAL

CR is a form of group therapy that uses a hybrid approach of restorative and strategy based methods to improve areas of cognition (ie. attention, memory, processing speed and learning) through the use of computerized exercises. CR is administered in groups consisting of 2-8 participants and one or two therapists. The CR groups meet twice per week for two hours per session over twelve weeks, for a total of 24 sessions.

Other: Cognitive Remediation Therapy

Interventions

Cognitive Remediation Therapy OTHER

Cognitive Remediation is a well-established psychotherapy that aims to improve neurocognitive abilities such as memory performance, executive functioning, processing speed, and attention.

Cognitive Remediation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 years and above. The rationale of age cutoff of 55 is that this age is considered a typical geriatric age cutoff for participants with LLS.
• Any race or ethnicity.
• Females and males.
• Meets DSM-V criteria for a current diagnosis of schizophrenia or schizoaffective disorder.
• 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 and medically stable by one of 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
• 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, M6J1H4, Canada

Location

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Study Officials

• Angela Golas, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Geriatric Psychiatrist

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: October 4, 2018
• Study Start: October 24, 2018
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: September 30, 2020

Record last verified: 2020-09

Locations

CA (1)