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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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.

Canada1 site
  • University of Calgary

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

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.

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 groups in NCT02582528
Study groupRoleWhat they receive
cognitive remediation treatment and MIExperimentalCognitive 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 treatmentActive comparatorCognitive 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted21 Oct 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionMar 2017
  4. Study completionMar 2017

Why it stopped: recruitment difficulties

Resources

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)
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

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.

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