Goal-Management Training for HIV

Not currently recruiting at 6 trial locations

Overseen By Adria Quigley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Dementia, Neurological disorder, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how goal management training might help people with HIV improve brain health and overall well-being. It examines whether setting personal goals before starting a healthy lifestyle program can enhance memory, concentration, and problem-solving skills. Participants will receive either a combination of goal management training with a healthy lifestyle program or just the healthy lifestyle program alone. Individuals who have lived with HIV for at least a year and experience challenges like forgetfulness or trouble focusing might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for those living with HIV.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that goal-management training is safe for individuals with HIV?

Research has shown that Goal-Management Training (GMT) is generally safe and easy to handle. In studies, people with stable HIV have used GMT and found it manageable and acceptable, meaning they could do it without much difficulty. The studies reported no serious side effects or safety issues. This suggests that GMT is a low-risk option for those considering joining the clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about goal-management training (GMT) for individuals with HIV because it offers a novel approach to cognitive rehabilitation. Unlike traditional treatments that primarily focus on managing physical symptoms of HIV, GMT targets cognitive functions, aiming to improve patients' mental organization and goal-setting abilities. This approach is combined with a Healthy Lifestyle Program, which uses modern technology like activity trackers and goal-monitoring apps, empowering participants to take an active role in their health management. By addressing both cognitive and physical aspects, this combined strategy may offer a more holistic improvement in quality of life for those living with HIV.

What evidence suggests that goal-management training is effective for improving brain health in individuals with HIV?

Research has shown that Goal Management Training (GMT), which participants in this trial may receive, can greatly enhance thinking skills, such as memory and focus, in people with HIV. One study found that those who used GMT noticed clear improvements in their mental abilities. Another study highlighted that GMT might assist people with HIV who face brain-related challenges. Further research suggests that GMT leads to moderate but lasting improvements in skills like planning and decision-making. Overall, these findings indicate that GMT could be a valuable tool for boosting brain health in people living with HIV. ^{2 4 6 7 8}

Who Is on the Research Team?

Nancy Mayo, PhD

Principal Investigator

McGill University

Marie-Josée Brouillette, MD

Principal Investigator

McGill University

Lesley Fellows, PhD/MD

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for individuals who have been living with HIV for at least a year, can consent in French or English, and show signs of cognitive frailty or don't meet 'successful aging' criteria. It's not suitable for those unable to do moderate exercise, with a life expectancy under 3 years, active brain infections, hepatitis C needing treatment during the study, dementia affecting cognition, other neurological disorders impacting thinking skills, psychosis or recent substance abuse.

Inclusion Criteria

HIV+ for at least 1 year

I can communicate well in either French or English.

Able to give written informed consent

Exclusion Criteria

Life expectancy < 3 years or other personal factor limiting the ability to participate in follow-up

Known psychotic disorder

Current substance dependence or abuse within the past 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ready, Set Workshop

Participants attend a workshop to learn about the My Personal Brain Health Dashboard and receive training on using the Garmin vívofit 4 Activity Tracker and the My Goals app.

1 day

1 visit (in-person)

Treatment

Participants are randomized to either Goal Management Training (GMT) with Healthy Lifestyle Program (HLP) or HLP alone. The GMT group undergoes 9 sessions of cognitive rehabilitation over 9 weeks.

52 weeks

9 visits (in-person) for GMT group

Follow-up

Participants are monitored for adherence to health recommendations and achievement of health-related goals.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Goal-management training

Trial Overview The trial tests if adding Goal Management Training (GMT) to a Healthy Lifestyle Program (HLP) leads to better adherence to health recommendations and outcomes than the HLP alone. Participants will be randomly assigned either GMT plus HLP or just HLP and their brain health and general health outcomes will be compared.

How Is the Trial Designed?

Group I: GMT Intervention + Health Lifestyle Program Experimental Treatment 1 Intervention

The intervention group will participate in GMT, a standardized cognitive rehabilitation program which will be given as per the manual and which consists of 9 sessions each 2-hours in duration. They will also participate in the Healthy Lifestyle Program (HLP), which includes physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability.

Group II: Health Lifestyle Program Active Control 1 Intervention

The control group enters directly into the HLP without any other study visits. The HLP includes physical activity monitoring (step count, calories burned and sleep) with the Garmin vívofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36345346/

Efficacy potential of Goal Management Training to improve ... There was a meaningful improvement in self-reported cognition in those adherent to the intervention. GMT is a promising intervention for people ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422001405

Efficacy potential of Goal Management Training to improve ... The aim of this study was to ascertain feasibility, acceptability, and efficacy potential of GMT for people (≥50 years) with stable HIV infection scoring low on ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4801659/

Abbreviated Goal Management Training Shows ... This study examined the effectiveness of Goal Management Training (GMT) alone or GMT as part of a metacognitive training among HIV/SUD individuals with ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/24/NCT03168724/Prot_SAP_000.pdf

Canadian Foundation for AIDS Research Efficacy potential of goal management training to improve cognitive function in ... Goal Management training in people living with HIV. Sponsor.

5. tandfonline.com tandfonline.com/doi/full/10.1080/09602011.2018.1438294

Effectiveness of goal management training® in improving ... The analysis suggests that GMT is an effective intervention, leading to moderate improvements in executive functions that are usually maintained at follow-up.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9636436/

Efficacy potential of Goal Management Training to improve ... The aim of this study was to ascertain feasibility, acceptability, and efficacy potential of GMT for people (≥50 years) with stable HIV ...

7. researchgate.net researchgate.net/publication/365072383_Efficacy_potential_of_Goal_Management_Training_to_improve_cognitive_function_in_older_people_living_with_HIV

Efficacy potential of Goal Management Training to improve ... The aim of this study was to ascertain feasibility, acceptability, and efficacy potential of GMT for people (≥50 years) with stable HIV infection scoring low on ...

8. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2025.1644139/full

Goals in motion: exploring goal setting among adults living ... We conducted a multi-method, longitudinal, observational study using data from an online community-based exercise (CBE) intervention study (12).