Psychosocial Intervention for Older HIV+ Adults With HAND (IN-HAND)

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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Aging; Mild Cognitive Impairment; Group, Peer
• Intervention / Treatment: Behavioral: CRGT; Behavioral: HIV group therapy

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew D Eaton, MSW; Phone Number: 283 4163408484; Email: aeaton@actoronto.org
• Study Contact Backup: Name: Sharon L Walmsley, MD; Phone Number: 4163403871; Email: sharon.walmsley@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network, Toronto General Hospital
    • Toronto, Ontario, Canada, M4Y1Y5
      • AIDS Committee of Toronto (ACT)
    • Toronto, Ontario, Canada, M5B1M4
      • St. Michael's Hospital Neurobehavioral Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive remediation group therapy; 8 weekly 3-hour sessions of CRGT	Behavioral: CRGT; 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.
Active Comparator: Mutual aid support group; 8 weekly 3-hour sessions of HIV group therapy	Behavioral: HIV group therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Session Attendance	Number of Participants who Attended at least 80% of the Group Sessions.	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. 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.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress	Assessed by the 'HIV/AIDS Stress Scale' at three time points. Score from 0 to 116. Lower scores mean better outcomes.	Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Sustained Use of Brain Training Activities	Self-report at three time points	Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Sustained Use of Mindfulness Strategies	Assessed by the 'Five Facet Mindfulness Questionnaire - Short Form' at three time points. Score from 24 to 120. Higher scores mean better outcomes.	Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21). Score from 0 to 26
Change in Anxiety	Assessed by the 'Anxiety in Cognitive Impairment and Dementia Scale' at three time points. Score from 0 to 26. Lower scores mean better outcomes.	Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Change in Coping	Assessed by the 'Coping Self-Efficacy Scale of Health Problems' at three time points. Score from 0 to 30. Higher scores mean better outcomes.	Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Unity Health Toronto; CIHR Canadian HIV Trials Network; AIDS Committee of Toronto; Factor-Inwentash Faculty of Social Work, University of Toronto
• Investigators: Principal Investigator: Sharon L Walmsley, MD, University Health Network, Toronto

Publications and helpful links

General Publications

• Eaton AD, Walmsley SL, Craig SL, Rourke SB, Sota T, McCullagh JW, Fallon BA. Protocol for a pilot randomised controlled trial evaluating feasibility and acceptability of cognitive remediation group therapy compared with mutual aid group therapy for people ageing with HIV-associated neurocognitive disorder (HAND) in Toronto, Canada. BMJ Open. 2019 Oct 31;9(10):e033183. doi: 10.1136/bmjopen-2019-033183.

Helpful Links

• Plain language summary

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: HIV-Associated Neurocognitive Disorder (HAND); Cognitive remediation group therapy; Mutual aid group therapy
• Additional Relevant MeSH Terms: Mental Disorders; Cognition Disorders; Cognitive Dysfunction; Neurocognitive Disorders
• Other Study ID Numbers: CTNPT 029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No