HIV/AIDSIN-HANDNCT03483740
Psychosocial Intervention for Older HIV+ Adults With HAND
A study testing CRGT and HIV group therapy in people with HIV/AIDS and Aging, run by University Health Network, Toronto at 3 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Aging, Mild Cognitive Impairment
- What is being tested?
- CRGT and HIV group therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesCanada
- Study dates
- 6 Aug 2018to 31 Dec 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
AIDS Committee of Toronto (ACT)
Toronto, Ontario, M4Y1Y5
St. Michael's Hospital Neurobehavioral Research Unit
Toronto, Ontario, M5B1M4
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2N2
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV/AIDS, Aging, Mild Cognitive Impairment, Group, Peer
- Being tested
- CRGT, HIV group therapy
- Keywords
- HIV-Associated Neurocognitive Disorder (HAND), Cognitive remediation group therapy, Mutual aid group therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRGTBehavioural
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.
HIV group therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive remediation group therapy | Experimental | 8 weekly 3-hour sessions of CRGT Receives: Behavioral: CRGT |
| Mutual aid support group | Active comparator | 8 weekly 3-hour sessions of HIV group therapy Receives: Behavioral: HIV group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Session Attendance
Number of Participants who Attended at least 80% of the Group Sessions.
Measured: 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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start6 Aug 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network, Unity Health Toronto, AIDS Committee of Toronto, Factor-Inwentash Faculty of Social Work, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Sharon L Walmsley, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483740
- Sponsor's protocol ID
- CTNPT 029
- Acronym
- IN-HAND
- Status last verified
- Nov 2022
- First submitted
- 9 Jan 2018
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31676660