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HivNCT03168724

Goal Management Training, Executive Functions and HIV

A study testing GMT intervention in people with Hiv, run by McGill University at 2 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 46 years and older
Conditions the study is for
Hiv
What is being tested?
GMT intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesCanada
Study dates
Apr 2016to Aug 2021
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 46 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Clinique Medicale L'Actuel

    Montreal, Quebec, H2L 4P9

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: Efficacy Potential of Goal Management Training to Improve Cognitive Function in Older People Living With HIV

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.

Read the detailed description

Rehabilitation is a well-established approach to maintain function in the face of chronic disease, and holds promise for addressing the health challenges faced by older people with HIV. A Canadian-led knowledge synthesis review published in 2014 identified cognitive rehabilitation as a promising approach in HIV, but highlighted the absence of high quality, HIV-specific evidence in this area. A recent focused review also highlights the dearth of evidence on this topic. Very few studies have been published, and to date all have been restricted to computerized training programs only. While there is limited evidence for computerized cognitive rehabilitation in any context, there is better evidence for more conventional, in-person rehabilitation approaches, at least in other neurological disorders. Although computerized training is appealing because it is more feasible to deliver on a wide scale than conventional cognitive rehabilitation, The researchers propose that the first step should be to establish an evidence base regarding the efficacy of any form of cognitive rehabilitation in HIV. Evidence of efficacy of a 'high dose' established rehabilitation method could be followed by work to define the key elements, and to study how those elements could be delivered most cost-effectively, but there is no point in pursuing these secondary steps if the most well-established cognitive rehabilitation approaches do not show efficacy. Thus, the researchers propose to test conventional rehabilitation as a crucial first step is a research program focused on evidence-based interventions for improving brain health in HIV.

There is no gold standard conventional cognitive rehabilitation program, but most existing approaches combine face-to-face therapy with at home practice over a period of at least several weeks. In the absence of a gold standard, the researchers have selected one such program: Goal Management Training (GMT). This program targets executive dysfunction, which is a central problem in HIV-associated neurocognitive disorder. GMT is grounded in a neurobiological framework and was developed based on nearly two decades of research on practical approaches to minimizing the impact of executive dysfunction, aiming to help people with brain injury manage real life tasks. The program teaches self-management principles, stress management and mindfulness, and trains participants in the use of several explicit 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 seven 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. Evidence from randomized trials shows that this intervention leads to (i) significant improvements in performance on cognitive tests, including naturalistic tests of real life tasks, (ii) reduced self-reported cognitive difficulties, and (iii) significant improvements in everyday function compared to either a wait-list condition or a general brain health education control. Positive effects have been found in older people with cognitive difficulties, and neurological populations with mild cognitive impairment including mild traumatic brain injury, stroke and spina bifida. 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 pilot project is nested within an ongoing observational cohort study that aims to understand and address the heterogeneous, multi-factorial nature of compromised brain health in people living with HIV. Study participants will be randomly selected from those participating in the ongoing, longitudinal Positive Brain Health Now (+BHN) study at 2 sites in Montreal (The Montreal Chest Institute and L'Actuel Medical Clinic). This CIHR Team Grant-supported observational, prospective cohort study has enrolled 840 consecutive patients attending 5 HIV clinics across Canada, who are followed every 9 months for 27 months.

Procedure Participants will be recruited either at the time of their routine +BHN study visit, or by phone or by email. Informed consent will occur with the therapist during the first GMT group session during which they will also complete a questionnaire regarding any cognitive concerns they may have (Communicating Cognitive Concerns-C3Q). At the end of the last GMT session, they will be asked to complete the C3Q again. Then, within 4 weeks of completing the GMT program, they will be asked to repeat the B-CAM, coincident with the +BHN study visit if timing permits.

Intervention The standard GMT program lasts 9 weeks and involves 9 weekly 2-hour small group sessions led by a trained therapist. It follows a manualized program that teaches participants a series of techniques to build attention and executive function, and shows them how to implement these techniques in their everyday life. The small group sessions allow individualization of the training to show how it can be applied to meet the particular challenges reported by participants, and explicitly encourage participants to share their challenges and successes with others in the group to promote learning and engagement with the program. The sessions are reinforced with homework, in which participants practice what they have learned. Sessions will be audiotaped for later review by the trainer and/or study investigators to ensure adherence to the intervention manual. The material, including homework, is provided in a workbook that participants use throughout the training, and keep for later reference.

Conditions
Hiv
Being tested
GMT intervention
Keywords
Cognition, Intervention, Self-management, Rehabilitation
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GMT interventionBehavioural

Study groups in NCT03168724
Study groupRoleWhat they receive
GMT InterventionExperimentalOver the course of 9 weeks, there are 2h-group sessions with a therapist.
Receives: Behavioral: GMT intervention
ControlNo interventionGroup not getting the intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance measure (B-CAM)

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

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

Secondary outcomes (2)
  1. Tower of London (cognitive outcome measure)

    Assesses planning and mental flexibility

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

  2. Communicating Cognitive Concerns (C3Q)

    Evaluates cognitive concerns participants may have

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study startApr 2016
  3. Primary completionAug 2019
  4. Study completionAug 2021 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168724
Sponsor's protocol ID
MUHC-16-031
Status last verified
Sep 2020
First submitted
28 Apr 2017
Last updated
2 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GMT intervention in people with Hiv, run by McGill University at 2 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Performance measure (B-CAM) (time frame: Up to 9 months before the intervention and up to 2 months after the intervention). 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 2 Sep 2020.

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Goal Management Training, Executive Functions and HIV | AzTrials