Schizophrenia Clinical Trial
Official title:
Cognitive Remediation Therapy for Participants With Late-Life Schizophrenia
Verified date | September 2020 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | March 12, 2020 |
Est. primary completion date | March 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. Any race or ethnicity. 3. Females and males. 4. Meets DSM-V criteria for a current diagnosis of schizophrenia or schizoaffective disorder. 5. 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. 6. Willingness and ability to speak English 7. Willingness to provide informed consent 8. 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: 1. Meets criteria for a cognitive disorder secondary to a neurological or other medical disorder 2. Diagnosis of bipolar disorder or current major depressive episode 3. Meets diagnostic criteria for substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine 4. Electroconvulsive Therapy (ECT) within 6 months of initial assessment |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assess effect of Cognitive Remediation (CR) on tolerability of CR according to the percentage of participants completing the 12-week course | Range of 0-100% individuals completing, with 100% completers indicating best possible outcome. | approximately 12 weeks after the baseline | |
Secondary | Change in general, positive, and negative symptoms of Schizophrenia as assessed by the Positive and Negative Syndrome Scale | Total score range of 30-210, 30 indicating the best possible score | At baseline and approximately 12 weeks after the baseline | |
Secondary | Change in depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia | Score range of 0-27, 0 indicating the best possible score | At baseline and approximately 12 weeks after the baseline | |
Secondary | Change in visuospatial/executive domains of cognition as assessed by the Trail making Test B and A | Scored via number of correct moves ranging from 0-24, 24 indicating best possible score. Also scored via number of errors made, ranging from 0-24, 0 indicating best possible score | At baseline and approximately 12 weeks after the baseline | |
Secondary | 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) | Subscales include List Learning (0-40, 40 indicating best possible score) and Story Memory (0-24, 24 indicating best possible score) for testing of immediate memory. Figure Copy (0-20, 20 indicating best possible score) and Line Orientation (0-20, 20 indicating best possible score) for testing of visuospatial/constructional cognition. Picture Naming (0-10, 10 indicating best possible score) and Semantic Fluency (4-40, 40 indicating best possible score) for testing of language. Digit Span (0-16, 16 indicating best possible score) and Coding (0-89, 89 indicating best possible score) for testing of attention. List Recall (0-10, 10 indicating best possible score), List Recognition (0-20, 20 indicating best possible score), Story Recall (0-12, 12 indicating best possible score), and Figure Recall (0-20, 20 indicating best possible score) for testing of delayed memory. | At baseline and approximately 12 weeks after the baseline | |
Secondary | Change in executive functioning and planning ability as assessed by the Tower of London | Change in executive functioning and planning ability as assessed by the Tower of London | At baseline and approximately 12 weeks after the baseline | |
Secondary | Change in verbal working memory as assessed by the Letter Number Span | Score range of 0-24, 24 indicating best possible score | At baseline and approximately 12 weeks after the baseline | |
Secondary | Change in visual working memory as assessed by the Wechsler Memory Scale Spatial Span | Scored via number of correct forward items (0-16, 16 indicating best possible score). Also scored via number of correct backwards items (0-16, 16 indicating best possible score) | At baseline and approximately 12 weeks after the baseline | |
Secondary | Degree of anticholinergic burden of medication used by our participants, quantified by the Anticholinergic Burden Scale (ACB) | A total ACB scale score of three or more is considered clinically relevant | At baseline |
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