NCT03168724

Brief Summary

Goal Management Training (GMT) is a cognitive rehabilitation program targeting executive dysfunction (problems with attention, reasoning, problem solving, planning, etc), which is a central problem in HIV-associated neurocognitive disorder. It teaches self-management principles, stress management and mindfulness, and trains participants in the use of several strategies to reduce cognitive load in everyday tasks, and methods to cue attention to maintain focus on specific tasks. GMT is a manualized protocol with set content conveyed through a combination of slides and a workbook. Two-hour small group sessions are led, in person, by a trained therapist once a week, for nine weeks. The small group sessions allow participants to learn from each other, enhancing engagement. GMT has been shown to improve cognitive function in a variety of neurological conditions, as well as in healthy older people with cognitive concerns. These improvements have been shown to last at least 6 months in some studies and are accompanied by changes in the brain networks underlying executive function. GMT is thus a well-validated, high yield intervention with which to test the potential of cognitive rehabilitation in older HIV+ people with cognitive concerns. The researchers hypothesize that GMT will lead to improved cognitive function as assessed by better performance on cognitive tests and reduced self-reported cognitive difficulties in people with stable HIV infection who report cognitive difficulties at baseline.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

3.3 years

First QC Date

April 28, 2017

Last Update Submit

September 1, 2020

Conditions

Hiv

Keywords

CognitionInterventionSelf-managementRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Performance measure (B-CAM)

    We will be looking at changes on the B-CAM (brief cognitive ability measure) pre- and post-intervention

    Up to 9 months before the intervention and up to 2 months after the intervention

Secondary Outcomes (2)

  • Tower of London (cognitive outcome measure)

    Up to 9 months before the intervention and up to 2 months after the intervention

  • Communicating Cognitive Concerns (C3Q)

    On the first day of the intervention and 9 weeks after the beginning of the intervention

Study Arms (2)

GMT Intervention

EXPERIMENTAL

Over the course of 9 weeks, there are 2h-group sessions with a therapist.

Behavioral: GMT intervention

Control

NO INTERVENTION

Group not getting the intervention

Interventions

GMT interventionBEHAVIORAL
GMT Intervention

Eligibility Criteria

Age46 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infection for at least 1 year
  • Able to communicate in French or English
  • Capable of providing informed consent
  • Over 45 years old
  • Subjective cognitive complaints
  • Performance on objective computerized cognitive tests that falss at or below 50th percentile of performance in the cohort (main study) as a whole)

You may not qualify if:

  • Presence of dementia
  • Life expectancy of 3 years or less
  • Other neurological disorder including opportunistic CNS infection, psychotic disorder
  • Current substance dependence or abuse
  • Hepatitis C requiring interferon therapy during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Medicale L'Actuel

Montreal, Quebec, H2L 4P9, Canada

Location

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Marie-Josee Brouillette, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

  • Lesley Fellows, MD/PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 30, 2017

Study Start

April 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2021

Last Updated

September 2, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)