Clinical trial NCT03483740: Psychosocial Intervention for Older HIV+ Adults With HAND
Official title: Cognitive Remediation Group Therapy to Improve Older Adults' Ability to Cope With HIV-Associated Neurocognitive Disorder (HAND)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Aging
Mild Cognitive Impairment
Group, Peer
Keywords: HIV-Associated Neurocognitive Disorder (HAND)
Cognitive remediation group therapy
Mutual aid group therapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: CIHR Canadian HIV Trials Network
name: Unity Health Toronto
name: AIDS Committee of Toronto
name: Factor-Inwentash Faculty of Social Work, University of Toronto
First posted: 2018-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Session Attendance
timeFrame: Three months
measure: Acceptability - Participant Satisfaction With Group Sessions
timeFrame: Three months
Secondary outcomes:
Other outcomes:
measure: Change in Stress
timeFrame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
measure: Sustained Use of Brain Training Activities
timeFrame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
measure: Sustained Use of Mindfulness Strategies
timeFrame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21). Score from 0 to 26
measure: Change in Anxiety
timeFrame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
measure: Change in Coping
timeFrame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Locations:
city: Toronto
country: Canada
facility: AIDS Committee of Toronto (ACT)
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital Neurobehavioral Research Unit
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Sharon L Walmsley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.