NCT02582528

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

October 16, 2015

Last Update Submit

March 30, 2017

Conditions

DepressionPsychosisAnxietyMental Illness

Keywords

cognitive remediationcognitionyouthmental healthfunctional outcome

Outcome Measures

Primary Outcomes (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.

    one year

Secondary Outcomes (3)

  • Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Social (GFS) scale.

    one year

  • Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Role (GFR) scale.

    one year

  • Functional capacity assessment pre- and post-CRT in youth at risk of SMI using Social Skills Performance Assessment (SSPA).

    one year

Study Arms (2)

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.

Behavioral: Cognitive remediation treatmentBehavioral: Motivational Interviewing

cognitive remediation treatment

ACTIVE COMPARATOR

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

Behavioral: Cognitive remediation treatment

Interventions

Cognitive remediation treatmentBEHAVIORAL

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

Also known as: My Brain Solutions
cognitive remediation treatmentcognitive remediation treatment and MI
Motivational InterviewingBEHAVIORAL

A client-centered, directive method for enhancing intrinsic motivation to change.

Also known as: MI
cognitive remediation treatment and MI

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

DepressionPsychotic DisordersAnxiety DisordersMental DisordersPsychological Well-Being

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Danijela Piskulic, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 21, 2015

Study Start

February 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CA(1)