Psychosocial Intervention for Older HIV+ Adults With HAND

Aging Clinical Trial

— IN-HAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483740
• Other study ID #: CTNPT 029
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). The cognitive remediation therapy will include tablet-based cognitive training and mindfulness-based stress reduction sessions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Dysfunction
• Group, Peer
• HIV/AIDS
• Mild Cognitive Impairment
• Neurocognitive Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	AIDS Committee of Toronto (ACT)	Toronto	Ontario
Canada	St. Michael's Hospital Neurobehavioral Research Unit	Toronto	Ontario
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
University Health Network, Toronto	AIDS Committee of Toronto, CIHR Canadian HIV Trials Network, Factor-Inwentash Faculty of Social Work, University of Toronto, Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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
Other	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)
Other	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)
Primary	Feasibility - Session Attendance	Number of Participants who Attended at least 80% of the Group Sessions.	Three months
Primary	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

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