Psychosocial Intervention for Older HIV+ Adults With HAND

Not Applicable

Completed

• Conditions: HIV/AIDS; Mild Cognitive Impairment; Aging; Group, Peer
• Interventions: Behavioral: CRGT; Behavioral: HIV group therapy

• Registration Number: NCT03483740
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-03-28
• Study First Posted: 2018-03-30
• Study Start: 2018-08-06
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2022-11
• Results First Submitted: 2022-11-09
• Results First Submitted QC: 2023-09-29
• Last Update Submitted: 2023-09-29
• Results First Posted: 2024-03-29
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Male or female; aged ≥ 40 years
2. Documented HAND diagnosis of Mild Neurocognitive Disorder (MND)
3. ≥ 5 years of HIV infection
4. Provided consent to St. Michael's Hospital to be contacted for future research studies
5. Can feasibly attend 8 weeks of group therapy in downtown Toronto

Exclusion Criteria

1. Documented HAND diagnosis of asymptomatic neurocognitive impairment (ANI) or HIV-associated dementia (HAD)
2. Hospitalization within past 1 month
3. Inability to communicate in English
4. Inability to use a tablet
5. Anyone deemed by the principal investigator to be disruptive to a support group setting

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive remediation group therapy	CRGT	8 weekly 3-hour sessions of CRGT
Mutual aid support group	HIV group therapy	8 weekly 3-hour sessions of HIV group therapy

Primary Outcome Measures

Name	Time	Method
Feasibility - Session Attendance	Three months	Number of Participants who Attended at least 80% of the Group Sessions.
Acceptability - Participant Satisfaction With Group Sessions	Three months	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.; The Helping Characteristics of Self-Help and Support Group Measure contains 22 items that are scored on a 5-point-Likert style scale for a minimum score of 22 and a maximum score of 110. Higher scores indicate better outcome (outcome being satisfaction with support group). There are no subscales.

Trial Locations

Locations (3)

St. Michael's Hospital Neurobehavioral Research Unit; 🇨🇦 Toronto, Ontario, Canada

University Health Network, Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

AIDS Committee of Toronto (ACT); 🇨🇦 Toronto, Ontario, Canada