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Completed

NCT Number: NCT03483740

Psychosocial Intervention for Older HIV+ Adults With 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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Aging Blood-Borne Infections Cognition Disorders Cognitive Dysfunction Communicable Diseases Genital Diseases Group, Peer HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIDS Committee of Toronto (ACT), Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CRGT

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Feasibility - Session Attendance

    Time frame: Three months

    Number of Participants who Attended at least 80% of the Group Sessions.

  2. Acceptability - Participant Satisfaction With Group Sessions

    Time frame: 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.

Other outcomes

  1. Change in Stress

    Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)

    Assessed by the 'HIV/AIDS Stress Scale' at three time points. Score from 0 to 116. Lower scores mean better outcomes.

  2. Sustained Use of Brain Training Activities

    Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)

    Self-report at three time points

  3. Sustained Use of Mindfulness Strategies

    Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21). Score from 0 to 26

    Assessed by the 'Five Facet Mindfulness Questionnaire - Short Form' at three time points. Score from 24 to 120. Higher scores mean better outcomes.

  4. Change in Anxiety

    Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)

    Assessed by the 'Anxiety in Cognitive Impairment and Dementia Scale' at three time points. Score from 0 to 26. Lower scores mean better outcomes.

  5. Change in Coping

    Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)

    Assessed by the 'Coping Self-Efficacy Scale of Health Problems' at three time points. Score from 0 to 30. Higher scores mean better outcomes.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

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

Registry information

Official study title

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

Acronym: IN-HAND

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2018
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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