Psychosocial Intervention for Older HIV+ Adults With HAND

Study Overview
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Brief Summary
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CTNPT 029 will test the feasibility and acceptability of cognitive remediation group therapy in older adults living with HIV who have been diagnosed with HIV-associated neurocognitive disorder (HAND). The cognitive remediation therapy will include tablet-based cognitive training and mindfulness-based stress reduction sessions.

Detailed Description
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Approximately half of the aging HIV-positive population will be affected by HAND, making cognitive impairment related to HIV a significant comorbidity in this population. With the development, access to, and early initiation of modern antiretroviral therapy (ART), HAND is less severe and less common than it once was. However, people who were treated with old therapies, ones that were less effective and with higher rates of toxicity compared to current regimens, or who experienced AIDS defining illnesses, may be affected by HAND more frequently and more severely. Issues with cognition, memory, processing new information, problem solving, and decision making are all potential symptoms. Psychosocial interventions have been used to decrease stress and depression and improve coping and quality of life in the general aging population experiencing cognitive impairment and depression. These techniques, which can vary widely, have not been fully tested in people aging with HAND. CTNPT 029 (a pilot trial funded by the CTN) seeks to enroll 16 people at St. Michael's Hospital in Toronto. Study participants will be randomized to either receive cognitive remediation group therapy (CRGT) or standard HIV group therapy (control group). Both group therapies consist of a series of weekly 3-hour sessions led by a certified social worker and a peer. The CRGT group will spend one hour per session on brain training exercises (PositScience Software) and the remaining two hours on mindfulness-based stress reduction (meditation, breathing exercises, etc.). The control group will focus on general health and wellbeing for people aging with HIV. Study investigators will determine the usefulness of the structure of the sessions and the feasibility and acceptability of performing a study of this kind.

Official Title
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Cognitive Remediation Group Therapy to Improve Older Adults' Ability to Cope With HIV-Associated Neurocognitive Disorder (HAND)

Conditions
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HIV/AIDS, Aging, Mild Cognitive Impairment, Group, Peer

Intervention / Treatment
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* Behavioral: CRGT
* Behavioral: HIV group therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female; aged ≥ 40 years Documented HAND diagnosis of Mild Neurocognitive Disorder (MND) ≥ 5 years of HIV infection Provided consent to St. Michael's Hospital to be contacted for future research studies Can feasibly attend 8 weeks of group therapy in downtown Toronto Exclusion Criteria: Documented HAND diagnosis of asymptomatic neurocognitive impairment (ANI) or HIV-associated dementia (HAD) Hospitalization within past 1 month Inability to communicate in English Inability to use a tablet Anyone deemed by the principal investigator to be disruptive to a support group setting

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pilot, parallel design, randomized, controlled trial (RCT) that will allocate a sample (n=16) of people (≥ 40 yrs old) aging with HIV who have been diagnosed with MND from St. Michael's Hospital (SMH) in Toronto to either arm 1: 8 weekly 3-hour sessions of CRGT; or arm 2: 8 weekly 3-hour sessions of HIV group therapy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive remediation group therapy<br>8 weekly 3-hour sessions of CRGT | Behavioral: CRGT<br>* Cognitive remediation group therapy (CRGT) will be comprised of 1/3 brain training exercises on tablets using PositScience software by BrainHQ and 2/3 mindfulness-based stress reduction (MBSR) involving various activities such as meditation, breathing exercises, etc. Intervention will comprise of 8 weekly 3-hour sessions.<br>|
| Active Comparator: Mutual aid support group<br>8 weekly 3-hour sessions of HIV group therapy | Behavioral: HIV group therapy<br>* These groups use a model of mutual aid to encourage peer-based discussion on the effects of living with HIV. Topics are determined by the group; facilitators ensure that safety is maintained throughout and make connections between participants as appropriate. Intervension will comprise of 8 weekly 3-hour sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - participant attendance at group sessions | The sampling frame is approximately 100 people. The following targets (all based on a denominator of 100) would need to be met for a larger study to be considered feasible: ▁(>)30% of those contacted agree to participate, ▁(>)25% complete the pre-test, ▁(>)20% attend the first session, ▁(>)16% complete the full series and complete the post-test. Each participant must attend 80% (8/10) of the group sessions to be considered as completing the series. | Three months | 
| Acceptability - participant satisfaction with group sessions | Participants will complete the Helping Characteristics of Self-Help and Support Groups Measure that will be complemented by questions about session length, number of sessions, activities used, and evaluation of facilitators. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention fidelity - how closely facilitators adhere to intervention model | Facilitators of both study arms will submit weekly session reports. These reports will include checklists of the therapy components; use of an average 80% of components listed will be considered as good fidelity. These reports will also include open-ended questions about the sessions, including questions on group dynamics, challenges faced, and detail on activities used. | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-Associated Neurocognitive Disorder (HAND), Cognitive remediation group therapy, Mutual aid group therapy