Clinical trial NCT03695614: Cognitive Remediation Therapy for Participants With Late-Life Schizophrenia
Official title: Cognitive Remediation Therapy for Participants With Late-Life Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Cognitive Remediation
Late Life Schizophrenia
Functional Impairment
Cognitive Deficit
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 34
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Thirty late life schizophrenia (LLS) participants, age 55 and over, will undergo the CR intervention after completion of the baseline assessments. CR is a group-based psychotherapy that will consist of two, 2-hour weekly therapist-guided classes over 12 weeks, with a half-hour lunch break. The 24 classes are divided into two iterations of 12 exercises each, repeated twice. CR consists of four techniques: (1) didactic teaching on the relevance of cognition for everyday functioning and the association between cognitive strategies and enhanced functioning (2) computerized drills targeting different cognitive domains, (3) in-class strategic monitoring to enhance metacognitive skills, and (4) discussion of the generalization of cognitive skills to daily life. The Brain Gym includes electronic tablets for participant use both during classroom sessions in addition to elective, drop-in practice sessions offered three times per week. Each group will consist of 4-6 participants. A group will be started once four to six consecutively referred participants complete baseline assessments. Each class is self-contained and the first class is always introductory to CR in order to enhance the comfort level with the computer equipment and program.

Each of the 24 classes will have one, 5-10 minute block of didactic teaching, two 45-minute blocks of drill-and-practice of the online exercises, and a 20-minute lunch break. Exercises are delivered via Scientific Brain Training (SBT) Pro (2009). Computer exercises are designed to be enjoyable and reinforcing, with the difficulty level gradually increasing over time. The therapists optimize competency and motivation by individualizing the exercises for each participant. The difficulty level parameters are manually titrated according to exercise adherence and difficulty level progression, targeting 80 percent accuracy in order to optimize competency and motivation. In order to optimize learning and retention outside of weekly classes, participants are encouraged to return to the computer lab for ongoing practice of the online exercises, targeting 40 minutes of homework exercises per weekday for a total target of 200 minutes per week. Online logs allow for monitoring the time spent completing the computer exercises. The therapists review the online logs on a weekly basis with the participants at the end of the didactic class and before planning the homework for the following week. Participants' successful completion of a given exercise to the highest difficulty level is charted in the Brain Gym using their anonymized computer log-in name to serve as positive reinforcement and recognition of their achievement while maintaining privacy.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the effect of CR on cognitive performance as indicated by total Montreal Cognitive Assessment (MoCA) scores
timeFrame: approximately 12 weeks after the baseline
Secondary outcomes:
measure: Assess effect of Cognitive Remediation (CR) on tolerability of CR according to the percentage of participants completing the 12-week course
timeFrame: approximately 12 weeks after the baseline
measure: Change in general, positive, and negative symptoms of Schizophrenia as assessed by the Positive and Negative Syndrome Scale
timeFrame: At baseline and approximately 12 weeks after the baseline
measure: Change in depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia
timeFrame: At baseline and approximately 12 weeks after the baseline
measure: Change in visuospatial/executive domains of cognition as assessed by the Trail making Test B and A
timeFrame: At baseline and approximately 12 weeks after the baseline
measure: 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)
timeFrame: At baseline and approximately 12 weeks after the baseline
measure: Change in executive functioning and planning ability as assessed by the Tower of London
timeFrame: At baseline and approximately 12 weeks after the baseline
measure: Change in verbal working memory as assessed by the Letter Number Span
timeFrame: At baseline and approximately 12 weeks after the baseline
measure: Change in visual working memory as assessed by the Wechsler Memory Scale Spatial Span
timeFrame: At baseline and approximately 12 weeks after the baseline
measure: Degree of anticholinergic burden of medication used by our participants, quantified by the Anticholinergic Burden Scale (ACB)
timeFrame: At baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Angela Golas, MD
role: PRINCIPAL_INVESTIGATOR
References: