SchizophreniaNCT03695614
Cognitive Remediation Therapy for Participants With Late-Life Schizophrenia
A study testing Cognitive Remediation Therapy in people with Schizophrenia and Cognitive Remediation, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Schizophrenia, Cognitive Remediation, Late Life Schizophrenia
- What is being tested?
- Cognitive Remediation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 24 Oct 2018to 12 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Cognitive Remediation, Late Life Schizophrenia, Functional Impairment, Cognitive Deficit
- Being tested
- Cognitive Remediation Therapy
- Medical subject headings
- Schizophrenia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation TherapyOther
Cognitive Remediation is a well-established psychotherapy that aims to improve neurocognitive abilities such as memory performance, executive functioning, processing speed, and attention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cognitive Remediation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Range of 0-100% individuals completing, with 100% completers indicating best possible outcome.
Measured: approximately 12 weeks after the baseline
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
Measured: At baseline and approximately 12 weeks after the baseline
Change in depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia
Score range of 0-27, 0 indicating the best possible score
Measured: 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
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
Measured: 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)
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.
Measured: At baseline and approximately 12 weeks after the baseline
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
Measured: At baseline and approximately 12 weeks after the baseline
Change in verbal working memory as assessed by the Letter Number Span
Score range of 0-24, 24 indicating best possible score
Measured: At baseline and approximately 12 weeks after the baseline
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)
Measured: At baseline and approximately 12 weeks after the baseline
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start24 Oct 2018
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Golas, Centre for Addiction and Mental Health
- Investigators
- Angela Golas, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695614
- Sponsor's protocol ID
- 083/2017
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2018
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Golas AC, Elgallab BM, Abdool PS, Bowie CR, Rajji TK. Cognitive remediation for patients with late-life schizophrenia: A follow-up pilot study. Int Psychogeriatr. 2025 Mar;37(2):100006. doi: 10.1016/j.inpsyc.2024.100006. Epub 2024 Dec 4.
PubMed 40086906
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation Therapy for Participants With Late-Life Schizophrenia
- ClinicalTrials.gov ID
- NCT03695614
- Acronym / sponsor ID
- 083/2017
- Conditions
- Schizophrenia, Cognitive Remediation, Late Life Schizophrenia, Functional Impairment, Cognitive Deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation | Experimental | Other: Cognitive Remediation TherapyCR 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediation TherapyCognitive Remediation is a well-established psychotherapy that aims to improve neurocognitive abilities such as memory performance, executive functioning, processing speed, and attention. | Other | Cognitive Remediation |
Primary outcome
Assess the effect of CR on cognitive performance as indicated by total Montreal Cognitive Assessment (MoCA) scores
Time frame: approximately 12 weeks after the baseline
Total score out of 30 possible points, with 30/30 indicating best possible score
9 secondary outcomes
Assess effect of Cognitive Remediation (CR) on tolerability of CR according to the percentage of participants completing the 12-week course
Time frame: approximately 12 weeks after the baseline
Change in general, positive, and negative symptoms of Schizophrenia as assessed by the Positive and Negative Syndrome Scale
Time frame: At baseline and approximately 12 weeks after the baseline
Change in depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia
Time frame: 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
Time frame: 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)
Time frame: At baseline and approximately 12 weeks after the baseline
Change in executive functioning and planning ability as assessed by the Tower of London
Time frame: At baseline and approximately 12 weeks after the baseline
Change in verbal working memory as assessed by the Letter Number Span
Time frame: At baseline and approximately 12 weeks after the baseline
Change in visual working memory as assessed by the Wechsler Memory Scale Spatial Span
Time frame: At baseline and approximately 12 weeks after the baseline
Degree of anticholinergic burden of medication used by our participants, quantified by the Anticholinergic Burden Scale (ACB)
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Derived from this study: PubMed 40086906Golas AC, Elgallab BM, Abdool PS, Bowie CR, Rajji TK. Cognitive remediation for patients with late-life schizophrenia: A follow-up pilot study. Int Psychogeriatr. 2025 Mar;37(2):100006. doi: 10.1016/j.inpsyc.2024.100006. Epub 2024 Dec 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Golas, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy in people with Schizophrenia and Cognitive Remediation, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of CR on cognitive performance as indicated by total Montreal Cognitive Assessment (MoCA) scores (time frame: approximately 12 weeks after the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.