DepressionNCT02582528
Cognitive Remediation in Youth at Risk of Serious Mental Illness
A study testing Cognitive remediation treatment and Motivational Interviewing in people with Depression and Psychosis, run by University of Calgary at 1 site in Canada.
Trial summary
The primary aim of the project is to test the effectiveness of a cognitive remediation treatment (CRT) program, My Brain Solutions (MBS), in addition to motivational interviewing (MI) in improving cognition and functional outcome of individuals at risk of SMI. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Depression, Psychosis, Anxiety
- What is being tested?
- Cognitive remediation treatment and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Mar 2017
- 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female participants aged 14-25 years with subthreshold mood and psychotic symptoms.
Who cannot join
- (i) meet criteria for current or lifetime Axis I bipolar or psychotic disorder (other Axis I disorders will not be exclusionary as they may be precursors to mood or psychotic disorders);
- (ii) IQ < 70;
- (iii) past or current history of a significant central nervous system disorder or serious medical disorder; and
- (iv) current pharmacological treatment that would be considered as an adequate trial of treatment for a SMI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Cognitive Remediation and Motivational Interviewing on Cognition and Functioning in Young People at Risk of Serious Mental Illness
The primary aim of the project is to test the effectiveness of a cognitive remediation treatment (CRT) program, My Brain Solutions (MBS), in addition to motivational interviewing (MI) in improving cognition and functional outcome of individuals at risk of SMI. An active control treatment consisting of CRT alone will be used. Hypotheses: 1. Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome.
Read the detailed description
Individuals identified to be at clinical high risk of psychosis (CHR) of psychosis already evidence cognitive deficits, which increase around the time of conversion. Much less is known about individuals that may be at risk of other serious mental disorders (SMI). However, early reports are suggesting that young people at risk of SMI who are deemed to have "attenuated syndromes" according to the clinical staging model of mental health disorders already evidence cognitive deficits. Therefore, cognition is an excellent treatment target. Furthermore, there is clear evidence, in both established psychiatric disorders such as schizophrenia, depression and bipolar disorder, and in CHR samples, that deficits in cognition are associated to poor functional outcome. Thus, treatments targeting cognition may consequently improve functional outcome. This is a pilot project to determine feasibility and sample size for a large randomized controlled trial of cognitive remediation therapy (CRT) in people at risk of SMI with CIHR and AIHS funding targets. The primary aim of the project is to test the effectiveness of a novel computerized CRT program in improving cognition in youth at risk of SMI following the addition of a counseling intervention, MI, to improve adherence to CRT. One group will receive CRT and the other CRT plus MI. Hypotheses: 1. Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome. This is a longitudinal, single blind, controlled pilot trial of CRT in persons at risk of SMI. Twenty-eight participants will be recruited from the Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study (PROCAN) study at the Calgary site led by Dr. J. Addington. Participants in the PROCAN project who meet operationally defined criteria as being at risk of SMI by meeting attenuated syndromes criteria will be included. Participants will be randomized to either the CRT condition consisting of a novel program called My Brain Fitness (MBS) and motivational interviewing (MI) or a control condition consisting of CRT alone, and will receive training that will be administered over a period of 10 weeks. Assessments will occur at baseline, post treatment (3 months) and at 12 months after baseline. Half of all participants will receive individual 1 hr MI once every 2 weeks for the duration of the cognitive remediation component of the study. The study clinicians who are master level psychologists, will deliver MI ensuring engagement of study participants. Time spent in therapy will be monitored and recorded. All of the data necessary for this study will be collected as part of the PROCAN assessment at baseline and 12 months. The one exception is that we will do an assessment of cognitive function, clinical symptoms and functional outcome at 10 weeks or immediately post treatment, which will take approximately 2.5 hours.
- Conditions
- Depression, Psychosis, Anxiety, Mental Illness
- Being tested
- Cognitive remediation treatment, Motivational Interviewing
- Keywords
- cognitive remediation, cognition, youth, mental health, functional outcome
- Medical subject headings
- Depression, Psychotic Disorders, Anxiety Disorders, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation treatmentBehavioural
Also called My Brain Solutions
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
Motivational InterviewingBehavioural
Also called MI
A client-centered, directive method for enhancing intrinsic motivation to change.
| Study group | Role | What they receive |
|---|---|---|
| cognitive remediation treatment and MI | Experimental | Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS) and motivational interviewing, a client-centered, directive method for enhancing intrinsic motivation to change. Receives: Behavioral: Cognitive remediation treatment; Behavioral: Motivational Interviewing |
| cognitive remediation treatment | Active comparator | Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS) Receives: Behavioral: Cognitive remediation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function assessment pre- and post-CRT in youth at risk of SMI using WebNeuro computerized cognitive battery
A web-based battery for assessing general and emotional cognition, completed at any computer using mouse and keyboard. The assessment has been validated against traditional paper-and-pencil tests and with established reliability, cross-cultural consistency and norms.
Measured: one year
Secondary outcomes (3)
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Social (GFS) scale.
GFS consists of 10 items that are used to provide a rating of current social functioning. Scores range between 1 and 10, with 10 indicating superior functioning and 1 representing severe dysfunction.
Measured: one year
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Role (GFR) scale.
GFR consists of 10 items that are used to provide a rating of current role or occupational functioning. Scores range between 1 and 10, with 10 indicating superior functioning and 1 representing severe dysfunction.
Measured: one year
Functional capacity assessment pre- and post-CRT in youth at risk of SMI using Social Skills Performance Assessment (SSPA).
The SSPA is focused on both verbal and nonverbal social skills that are needed to succeed in two different social interaction tasks. Higher scores on the SSPA indicate better social skills.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danijela Piskulic, University of Calgary
- Investigators
- Danijela Piskulic, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582528
- Sponsor's protocol ID
- UCalgary-MAT
- Status last verified
- Mar 2017
- First submitted
- 16 Oct 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Cognitive Remediation and Motivational Interviewing on Cognition and Functioning in Young People at Risk of Serious Mental Illness
- ClinicalTrials.gov ID
- NCT02582528
- Acronym / sponsor ID
- UCalgary-MAT
- Conditions
- Depression, Psychosis, Anxiety, Mental Illness
- Keywords
- cognitive remediation, cognition, youth, mental health, functional outcome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Oct 2015 (estimated)
- 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.
The primary aim of the project is to test the effectiveness of a cognitive remediation treatment (CRT) program, My Brain Solutions (MBS), in addition to motivational interviewing (MI) in improving cognition and functional outcome of individuals at risk of SMI. An active control treatment consisting of CRT alone will be used. Hypotheses: 1. Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome.
Detailed description
Individuals identified to be at clinical high risk of psychosis (CHR) of psychosis already evidence cognitive deficits, which increase around the time of conversion. Much less is known about individuals that may be at risk of other serious mental disorders (SMI). However, early reports are suggesting that young people at risk of SMI who are deemed to have "attenuated syndromes" according to the clinical staging model of mental health disorders already evidence cognitive deficits. Therefore, cognition is an excellent treatment target. Furthermore, there is clear evidence, in both established psychiatric disorders such as schizophrenia, depression and bipolar disorder, and in CHR samples, that deficits in cognition are associated to poor functional outcome. Thus, treatments targeting cognition may consequently improve functional outcome. This is a pilot project to determine feasibility and sample size for a large randomized controlled trial of cognitive remediation therapy (CRT) in people at risk of SMI with CIHR and AIHS funding targets. The primary aim of the project is to test the effectiveness of a novel computerized CRT program in improving cognition in youth at risk of SMI following the addition of a counseling intervention, MI, to improve adherence to CRT. One group will receive CRT and the other CRT plus MI. Hypotheses: 1. Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome. This is a longitudinal, single blind, controlled pilot trial of CRT in persons at risk of SMI. Twenty-eight participants will be recruited from the Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study (PROCAN) study at the Calgary site led by Dr. J. Addington. Participants in the PROCAN project who meet operationally defined criteria as being at risk of SMI by meeting attenuated syndromes criteria will be included. Participants will be randomized to either the CRT condition consisting of a novel program called My Brain Fitness (MBS) and motivational interviewing (MI) or a control condition consisting of CRT alone, and will receive training that will be administered over a period of 10 weeks. Assessments will occur at baseline, post treatment (3 months) and at 12 months after baseline. Half of all participants will receive individual 1 hr MI once every 2 weeks for the duration of the cognitive remediation component of the study. The study clinicians who are master level psychologists, will deliver MI ensuring engagement of study participants. Time spent in therapy will be monitored and recorded. All of the data necessary for this study will be collected as part of the PROCAN assessment at baseline and 12 months. The one exception is that we will do an assessment of cognitive function, clinical symptoms and functional outcome at 10 weeks or immediately post treatment, which will take approximately 2.5 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive remediation treatment and MI | Experimental | Behavioral: Cognitive remediation treatment, Behavioral: Motivational InterviewingCognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS) and motivational interviewing, a client-centered, directive method for enhancing intrinsic motivation to change. |
| cognitive remediation treatment | Active comparator | Behavioral: Cognitive remediation treatmentCognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS) |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Male and female participants aged 14-25 years with subthreshold mood and psychotic symptoms.
Key exclusion criteria (4 listed)
- (i) meet criteria for current or lifetime Axis I bipolar or psychotic disorder (other Axis I disorders will not be exclusionary as they may be precursors to mood or psychotic disorders);
- (ii) IQ < 70;
- (iii) past or current history of a significant central nervous system disorder or serious medical disorder; and
- (iv) current pharmacological treatment that would be considered as an adequate trial of treatment for a SMI.
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 treatmentAlso: My Brain SolutionsCognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS) | Behavioural | cognitive remediation treatment, cognitive remediation treatment and MI |
| Motivational InterviewingAlso: MIA client-centered, directive method for enhancing intrinsic motivation to change. | Behavioural | cognitive remediation treatment and MI |
Primary outcome
Cognitive function assessment pre- and post-CRT in youth at risk of SMI using WebNeuro computerized cognitive battery
Time frame: one year
A web-based battery for assessing general and emotional cognition, completed at any computer using mouse and keyboard. The assessment has been validated against traditional paper-and-pencil tests and with established reliability, cross-cultural consistency and norms.
3 secondary outcomes
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Social (GFS) scale.
Time frame: one year
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Role (GFR) scale.
Time frame: one year
Functional capacity assessment pre- and post-CRT in youth at risk of SMI using Social Skills Performance Assessment (SSPA).
Time frame: one year
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Danijela Piskulic, PhD principal investigator
University of Calgary
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 treatment and Motivational Interviewing in people with Depression and Psychosis, run by University of Calgary 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 1 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: stopped early, as of the sponsor's last update on 4 Apr 2017. 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 was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Cognitive function assessment pre- and post-CRT in youth at risk of SMI using WebNeuro computerized cognitive battery (time frame: one year). 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 4 Apr 2017.