search
Back to results

Cognitive Remediation in Youth at Risk of Serious Mental Illness

Primary Purpose

Depression, Psychosis, Anxiety

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive remediation treatment
Motivational Interviewing
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring cognitive remediation, cognition, youth, mental health, functional outcome

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female participants aged 14-25 years with subthreshold mood and psychotic symptoms.

Exclusion Criteria:

  • (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.

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cognitive remediation treatment and MI

cognitive remediation treatment

Arm Description

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.

Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 16, 2015
Last Updated
March 30, 2017
Sponsor
University of Calgary
search

1. Study Identification

Unique Protocol Identification Number
NCT02582528
Brief Title
Cognitive Remediation in Youth at Risk of Serious Mental Illness
Official Title
Pilot Study of Cognitive Remediation and Motivational Interviewing on Cognition and Functioning in Young People at Risk of Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Psychosis, Anxiety, Mental Illness
Keywords
cognitive remediation, cognition, youth, mental health, functional outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive remediation treatment and MI
Arm Type
Experimental
Arm Description
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.
Arm Title
cognitive remediation treatment
Arm Type
Active Comparator
Arm Description
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation treatment
Other Intervention Name(s)
My Brain Solutions
Intervention Description
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Other Intervention Name(s)
MI
Intervention Description
A client-centered, directive method for enhancing intrinsic motivation to change.
Primary Outcome Measure Information:
Title
Cognitive function assessment pre- and post-CRT in youth at risk of SMI using WebNeuro computerized cognitive battery
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Social (GFS) scale.
Description
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.
Time Frame
one year
Title
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Role (GFR) scale.
Description
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.
Time Frame
one year
Title
Functional capacity assessment pre- and post-CRT in youth at risk of SMI using Social Skills Performance Assessment (SSPA).
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female participants aged 14-25 years with subthreshold mood and psychotic symptoms. Exclusion Criteria: (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danijela Piskulic, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Cognitive Remediation in Youth at Risk of Serious Mental Illness

We'll reach out to this number within 24 hrs