Cognitive ImpairmentNCT03814122
Action-based Cognitive Remediation for First Episode Psychosis
A study testing Action-based cognitive remediation in people with Cognitive Impairment and Psychosis, run by University of Manitoba at 1 site in Canada.
Trial summary
Cognitive impairments are a core and enduring feature of first-episode psychosis and schizophrenia, and are associated with significant functional impairment. Cognitive remediation (CR) is a behavioural intervention that has been found to have a small to moderate effect on cognition in individuals with schizophrenia… Read more about this study
- Who is it for?
- Ages 18 to 37 years
- Conditions the study is for
- Cognitive Impairment, Psychosis
- What is being tested?
- Action-based cognitive remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 13 Feb 2019to 30 Nov 2019
- 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 18 to 37 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Involved in the Winnipeg Regional Health Authority's Early Psychosis Prevention and Intervention Service
- Must be at least 18 years old
- Be proficient in English
- Have stable medication orders for 3 months
- Have capacity to voluntarily consent to participate in the treatment study
Who cannot join
- Organic brain damage
- Intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effectiveness of Action-based Cognitive Remediation for First Episode Psychosis
Cognitive impairments are a core and enduring feature of first-episode psychosis and schizophrenia, and are associated with significant functional impairment. Cognitive remediation (CR) is a behavioural intervention that has been found to have a small to moderate effect on cognition in individuals with schizophrenia, and recent studies suggests that it leads to improved cognition in persons with first-episode psychosis. Results from a CR feasibility project that was conducted through the Winnipeg Regional Health Authority's Early Psychosis Prevention and Intervention Service (EPPIS) showed promising findings. Specifically, large effect sizes were found in the areas of verbal learning and self-esteem. Moreover, the intervention was found to be acceptable to the participants. However, the findings are limited by the sample size and lack of control group.
In this proposed study, the investigators seek to expand the scientific support for treating neurocognitive impairments in order to increase functional productivity associated with first-episode psychosis. A novel group CR program, action-based cognitive remediation (ABCR), has been developed by Dr. C. Bowie (co-investigator) to promote the generalization of cognitive skills to real-world activities. ABCR has been found to improve both cognition and functional competence in persons with schizophrenia. The primary outcome measure will examine whether ABCR results in improved executive functioning in persons with first-episode psychosis compared to psychiatric rehabilitation alone. Secondary outcome measures (e.g., memory, processing speed, self-esteem, emotional functioning, adaptive functioning) will also be analyzed.
Read the detailed description
The proposed study will be a two-group randomized control cross-over trial. Participants will be recruited from EPPIS and will be randomly assigned to receive ABCR or treatment-as-usual (TAU) for a period of 8 weeks. After this time, the TAU group will receive ABCR. TAU will be the psychiatric rehabilitation programming offered to all patients enrolled with EPPIS. ABCR will consist of two, 2-hour groups/week, for a period of 8 weeks. Each group session will consist of: (1) computerized cognitive training using Scientific Brain Training Pro (an online program used in previous CR and ABCR research), (2) strategic monitoring (i.e., increasing awareness of cognitive strategies used and learning to switch strategies as needed), (3) role-plays and simulations of real world tasks to facilitate the transfer of skills to functioning, and (4) goal setting and cognitive approach planning. ABCR builds on procedural learning skills with explicit work-related role-plays to facilitate the immediate and salient abstraction of drill and practice remediation techniques. The activities are work skills that were developed by Dr. Bowie (co-investigator) in collaboration with community vocational rehabilitation partners. The props match those used in work settings and were designed on a miniature scale and include a cash register, filing system, conveyer belt, cleaning closet, garden nursery, and secretarial station. The activities in ABCR capitalize on procedural learning skills through role-plays and props that simulate a work environment. In ABCR, the important aspects of drill and practice, strategic monitoring to enhance flexible problem solving approaches, and bridging are maintained. The role-plays immediately follow the computerized drill and practice exercise and therapists facilitate group discussions of how the cognitive skills and flexibility in thinking from drill and practice can be effective while directly engaged in an everyday work environment. Thus, the bridging used in ABCR is a tangible, procedural, and realistic. This approach to bridging differentiates the treatment from standard CR, where the discussion-based approach is limited by the auditory learning, memory, and abstraction deficits typically observed in psychosis. ABCR group sessions will be facilitated by the Primary Investigator and trained bachelor's or master's level research assistants/psychology residents who will be trained and supervised by the Primary Investigator. Participants will also be encouraged to complete computerized cognitive training using the online program, Scientific Brain Training Pro as supplemental homework exercises outside of the scheduled treatment group (20 minutes/day). Due to the online nature of this program, participants can access this program either at their personal homes or at EPPIS.
Evaluations of each participant's cognitive functioning, self-esteem, psychotic symptoms, and functional skills will be completed at baseline and post-treatment (approximately 8 weeks later). The TAU group will then participate in ABCR and all participants will be re-evaluated following completion of the second intervention (at approximately 16 weeks post-baseline). Testing will be administered by trained bachelor's or master's level research assistants who are blind to study hypothesis or group assignment. These assistants will be trained and supervised by the Primary Investigator. Test batteries will be presented in counterbalanced order and, when possible, alternate forms will be used to reduce the likelihood of practice effects.Using a repeated measures analysis of covariance (ANCOVA), the treatment and control group's post-intervention data will be compared while controlling for pre-treatment scores. For all analyses, p < .05 will be used as the statistical threshold for significance.
- Conditions
- Cognitive Impairment, Psychosis
- Being tested
- Action-based cognitive remediation, Waitlist Control Group
- Medical subject headings
- Cognitive Dysfunction, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action-based cognitive remediationBehavioural
Action-Based Cognitive Remediation (ABCR) is a new program that was developed to address the challenges of transferring cognitive gains to improved quality of life and reduced disability. ABCR combines traditional cognitive training with an added behavioural component (e.g., role-plays, simulations of real world tasks) to foster learning through rehearsal and procedural memory which increases the likelihood of participants bridging cognitive strategies into real-world activities. ABCR also includes goal setting and behavioural activation procedures to stimulate transfer of in-session gains to everyday life changes.
Waitlist Control GroupOther
Receive treatment-as-usual through regular early psychosis programming.
| Study group | Role | What they receive |
|---|---|---|
| ABCR Treatment Group | Experimental | Group that is immediately administered action-based cognitive remediation intervention. Receives: Behavioral: Action-based cognitive remediation |
| Waitlist Control Group | Active comparator | Group that is waitlisted (i.e., receives treatment-as-usual) and after approximately 8 weeks received action-based cognitive remediation intervention Receives: Behavioral: Action-based cognitive remediation; Other: Waitlist Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Executive Functioning; Wisconsin Card Sorting Test (Heaton and PAR Staff, 2005).
Commonly used neuropsychological computerized test to assess the ability to form abstract concepts, to shift and maintain set, and to utilize feedback. Total number of categories completed and perseverative errors (reported as t-score with range <20 to >80) will be reported. Higher values indicate better outcome. More information can be found at: http://www4.parinc.com/Products/Product.aspx?ProductID=WCST
Measured: Baseline, after approximately 8 weeks and 16 weeks
Secondary outcomes (8)
Change in Cognitive Functioning; Screen for Cognitive Impairment in Psychiatry (Purdon, 2005).
Scale for screening cognitive deficits in persons with schizophrenia and psychiatry, including verbal learning and memory, auditory working memory, verbal fluency and visuomotor tracking. Total score reported as a z-score (range of -3 to +3). Higher values indicate better performance.
Measured: Baseline, after approximately 8 weeks and 16 weeks
Change in Psychotic Symptoms; Brief Psychotic Rating Scale (Overall & Gorham, 1962).
A 24-item measure commonly used in research and clinical settings that is designed to quantify the severity of positive and negative symptoms of psychosis. Scale ranges from 24-168. Higher values indicate greater number and severity of symptoms.
Measured: Baseline, after approximately 8 weeks and 16 weeks
Change in Functional Skills; Canadian Objective Life Skills (COALS) (McDermid Vaz & Heinrichs)
Participants are examined with a series of role-playing tasks for their comprehension and planning of recreational activities, financial skills in handling money and writing checks, use of a telephone for instrumental communication, and ability to use information from bus schedules and maps to use public transportation effectively. Total score ranges from 0-60. Higher value indicates better performance.
Measured: Baseline, after approximately 8 weeks and 16 weeks
Change in Visual Memory; Brief visuospatial memory test-revised (Benedict, 1997).
Commonly-used neuropsychological measure of visual learning and memory that uses a multiple-figural test to assess immediate memory, delayed memory and recognition abilities. Recall scores are reported as t-scores (range: <20-80) and higher values indicate better performance. Please note that a copy of the test protocol cannot be provided due to copyright protection, but more information can be found at: http://www4.parinc.com/Products/Product.aspx?ProductID=BVMT.
Measured: Baseline, after approximately 8 weeks and 16 weeks
Change in Self-Esteem; Rosenberg Self-Esteem Scale (Rosenberg, 1965).
A 10-item measure that is commonly used to measure self-esteem. Respondents are asked to read a list of statements dealing with general feelings about themselves and rate each one on a four-point scale from SD =Strongly Disagree (score of 0) to SA =Strongly Agree (score of 3). Scores are summed to provide a total score for the measure. Total score ranges from 0-30, with higher values indicating higher self-esteem.
Measured: Baseline, after approximately 8 weeks and 16 weeks
Change in Disability Beliefs; World Health Organization Disability Assessment Schedule II (World Health Organization)
36-item self-administered measure that assesses disability in adults over 18 years. Total score ranges from 0-144 with higher scores indicating greater perceived disability.
Measured: Baseline, after approximately 8 weeks and 16 weeks
Change in Illness Beliefs; Personal Beliefs About Illness Questionnaire-Revised (Birchwood, Jackson, Brunet, Holden & Barton, 2012).
20-item, self-report measure that assesses common psychological reactions related to loss, social marginalization, shame, entrapment, and control in persons with a first-episode psychosis. Total score ranges from 0-60. Higher scores indicate negative reactions to the diagnosis.
Measured: Baseline, after approximately 8 weeks and 16 weeks
Change in Perceived Competence; Perceived Competence for Learning Scale
4-item self-report measure assessing person's feeling of competence to master learning material. Total score ranges from 4-28. Higher scores indicate greater perceived competence.
Measured: Baseline, after approximately 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start13 Feb 2019
- Primary completion14 Jun 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- The proposed study will be a two-group randomized control cross-over trial. Participants will be randomly assigned to receive ABCR or treatment-as-usual (TAU) for a period of 8 weeks. After this time, the TAU group will receive ABCR. Evaluations of the participant's cognitive functioning, self-esteem, psychotic symptoms, and functional skills will be completed at baseline, post-treatment (approximately 8 weeks), and 16 weeks later.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University
- Responsible party
- Sponsor
- Investigators
- Colleen Murphy, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814122
- Sponsor's protocol ID
- H2017:214
- Status last verified
- Jan 2020
- First submitted
- 12 Oct 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of Action-based Cognitive Remediation for First Episode Psychosis
- ClinicalTrials.gov ID
- NCT03814122
- Acronym / sponsor ID
- H2017:214
- Conditions
- Cognitive Impairment, Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Queen's University
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 23 Jan 2019 (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 impairments are a core and enduring feature of first-episode psychosis and schizophrenia, and are associated with significant functional impairment. Cognitive remediation (CR) is a behavioural intervention that has been found to have a small to moderate effect on cognition in individuals with schizophrenia, and recent studies suggests that it leads to improved cognition in persons with first-episode psychosis. Results from a CR feasibility project that was conducted through the Winnipeg Regional Health Authority's Early Psychosis Prevention and Intervention Service (EPPIS) showed promising findings. Specifically, large effect sizes were found in the areas of verbal learning and self-esteem. Moreover, the intervention was found to be acceptable to the participants. However, the findings are limited by the sample size and lack of control group.
In this proposed study, the investigators seek to expand the scientific support for treating neurocognitive impairments in order to increase functional productivity associated with first-episode psychosis. A novel group CR program, action-based cognitive remediation (ABCR), has been developed by Dr. C. Bowie (co-investigator) to promote the generalization of cognitive skills to real-world activities. ABCR has been found to improve both cognition and functional competence in persons with schizophrenia. The primary outcome measure will examine whether ABCR results in improved executive functioning in persons with first-episode psychosis compared to psychiatric rehabilitation alone. Secondary outcome measures (e.g., memory, processing speed, self-esteem, emotional functioning, adaptive functioning) will also be analyzed.
Detailed description
The proposed study will be a two-group randomized control cross-over trial. Participants will be recruited from EPPIS and will be randomly assigned to receive ABCR or treatment-as-usual (TAU) for a period of 8 weeks. After this time, the TAU group will receive ABCR. TAU will be the psychiatric rehabilitation programming offered to all patients enrolled with EPPIS. ABCR will consist of two, 2-hour groups/week, for a period of 8 weeks. Each group session will consist of: (1) computerized cognitive training using Scientific Brain Training Pro (an online program used in previous CR and ABCR research), (2) strategic monitoring (i.e., increasing awareness of cognitive strategies used and learning to switch strategies as needed), (3) role-plays and simulations of real world tasks to facilitate the transfer of skills to functioning, and (4) goal setting and cognitive approach planning. ABCR builds on procedural learning skills with explicit work-related role-plays to facilitate the immediate and salient abstraction of drill and practice remediation techniques. The activities are work skills that were developed by Dr. Bowie (co-investigator) in collaboration with community vocational rehabilitation partners. The props match those used in work settings and were designed on a miniature scale and include a cash register, filing system, conveyer belt, cleaning closet, garden nursery, and secretarial station. The activities in ABCR capitalize on procedural learning skills through role-plays and props that simulate a work environment. In ABCR, the important aspects of drill and practice, strategic monitoring to enhance flexible problem solving approaches, and bridging are maintained. The role-plays immediately follow the computerized drill and practice exercise and therapists facilitate group discussions of how the cognitive skills and flexibility in thinking from drill and practice can be effective while directly engaged in an everyday work environment. Thus, the bridging used in ABCR is a tangible, procedural, and realistic. This approach to bridging differentiates the treatment from standard CR, where the discussion-based approach is limited by the auditory learning, memory, and abstraction deficits typically observed in psychosis. ABCR group sessions will be facilitated by the Primary Investigator and trained bachelor's or master's level research assistants/psychology residents who will be trained and supervised by the Primary Investigator. Participants will also be encouraged to complete computerized cognitive training using the online program, Scientific Brain Training Pro as supplemental homework exercises outside of the scheduled treatment group (20 minutes/day). Due to the online nature of this program, participants can access this program either at their personal homes or at EPPIS.
Evaluations of each participant's cognitive functioning, self-esteem, psychotic symptoms, and functional skills will be completed at baseline and post-treatment (approximately 8 weeks later). The TAU group will then participate in ABCR and all participants will be re-evaluated following completion of the second intervention (at approximately 16 weeks post-baseline). Testing will be administered by trained bachelor's or master's level research assistants who are blind to study hypothesis or group assignment. These assistants will be trained and supervised by the Primary Investigator. Test batteries will be presented in counterbalanced order and, when possible, alternate forms will be used to reduce the likelihood of practice effects.Using a repeated measures analysis of covariance (ANCOVA), the treatment and control group's post-intervention data will be compared while controlling for pre-treatment scores. For all analyses, p < .05 will be used as the statistical threshold for significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed study will be a two-group randomized control cross-over trial. Participants will be randomly assigned to receive ABCR or treatment-as-usual (TAU) for a period of 8 weeks. After this time, the TAU group will receive ABCR. Evaluations of the participant's cognitive functioning, self-esteem, psychotic symptoms, and functional skills will be completed at baseline, post-treatment (approximately 8 weeks), and 16 weeks later.
| Arm | Type | Receives |
|---|---|---|
| ABCR Treatment Group | Experimental | Behavioral: Action-based cognitive remediationGroup that is immediately administered action-based cognitive remediation intervention. |
| Waitlist Control Group | Active comparator | Behavioral: Action-based cognitive remediation, Other: Waitlist Control GroupGroup that is waitlisted (i.e., receives treatment-as-usual) and after approximately 8 weeks received action-based cognitive remediation intervention |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Involved in the Winnipeg Regional Health Authority's Early Psychosis Prevention and Intervention Service
- Must be at least 18 years old
- Be proficient in English
- Have stable medication orders for 3 months
- Have capacity to voluntarily consent to participate in the treatment study
Key exclusion criteria (2 listed)
- Organic brain damage
- Intellectual disability
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 |
|---|---|---|
| Action-based cognitive remediationAction-Based Cognitive Remediation (ABCR) is a new program that was developed to address the challenges of transferring cognitive gains to improved quality of life and reduced disability. ABCR combines traditional cognitive training with an added behavioural component (e.g., role-plays, simulations of real world tasks) to foster learning through rehearsal and procedural memory which increases the likelihood of participants bridging cognitive strategies into real-world activities. ABCR also includes goal setting and behavioural activation procedures to stimulate transfer of in-session gains to everyday life changes. | Behavioural | ABCR Treatment Group, Waitlist Control Group |
| Waitlist Control GroupReceive treatment-as-usual through regular early psychosis programming. | Other | Waitlist Control Group |
Primary outcome
Change in Executive Functioning; Wisconsin Card Sorting Test (Heaton and PAR Staff, 2005).
Time frame: Baseline, after approximately 8 weeks and 16 weeks
Commonly used neuropsychological computerized test to assess the ability to form abstract concepts, to shift and maintain set, and to utilize feedback. Total number of categories completed and perseverative errors (reported as t-score with range <20 to >80) will be reported. Higher values indicate better outcome. More information can be found at: http://www4.parinc.com/Products/Product.aspx?ProductID=WCST
8 secondary outcomes
Change in Cognitive Functioning; Screen for Cognitive Impairment in Psychiatry (Purdon, 2005).
Time frame: Baseline, after approximately 8 weeks and 16 weeks
Change in Psychotic Symptoms; Brief Psychotic Rating Scale (Overall & Gorham, 1962).
Time frame: Baseline, after approximately 8 weeks and 16 weeks
Change in Functional Skills; Canadian Objective Life Skills (COALS) (McDermid Vaz & Heinrichs)
Time frame: Baseline, after approximately 8 weeks and 16 weeks
Change in Visual Memory; Brief visuospatial memory test-revised (Benedict, 1997).
Time frame: Baseline, after approximately 8 weeks and 16 weeks
Change in Self-Esteem; Rosenberg Self-Esteem Scale (Rosenberg, 1965).
Time frame: Baseline, after approximately 8 weeks and 16 weeks
Change in Disability Beliefs; World Health Organization Disability Assessment Schedule II (World Health Organization)
Time frame: Baseline, after approximately 8 weeks and 16 weeks
Change in Illness Beliefs; Personal Beliefs About Illness Questionnaire-Revised (Birchwood, Jackson, Brunet, Holden & Barton, 2012).
Time frame: Baseline, after approximately 8 weeks and 16 weeks
Change in Perceived Competence; Perceived Competence for Learning Scale
Time frame: Baseline, after approximately 8 weeks and 16 weeks
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 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Colleen Murphy, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action-based cognitive remediation in people with Cognitive Impairment and Psychosis, run by University of Manitoba 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 5 inclusion and 2 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 27 Jan 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?
Change in Executive Functioning; Wisconsin Card Sorting Test (Heaton and PAR Staff, 2005). (time frame: Baseline, after approximately 8 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2020.