Psychosocial Intervention for Older HIV+ Adults With HAND

NCT03483740 | Completed Results

• 1 other identifier: CTNPT 029
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV/AIDS; Aging; Mild Cognitive Impairment; Group, Peer

Keywords

HIV-Associated Neurocognitive Disorder (HAND); Cognitive remediation group therapy; Mutual aid group therapy

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (5)

• Change in Stress

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

• Sustained Use of Brain Training Activities

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

• Sustained Use of Mindfulness Strategies

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

Study Arms (2)

Cognitive remediation group therapy

EXPERIMENTAL

8 weekly 3-hour sessions of CRGT

Behavioral: CRGT

Mutual aid support group

ACTIVE COMPARATOR

8 weekly 3-hour sessions of HIV group therapy

Behavioral: HIV group therapy

Interventions

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.

Cognitive remediation group therapy

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.

Mutual aid support group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

AIDS Committee of Toronto (ACT)

Toronto, Ontario, M4Y1Y5, Canada

Location

St. Michael's Hospital Neurobehavioral Research Unit

Toronto, Ontario, M5B1M4, Canada

Location

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (1)

• 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.

  PMID: 31676660 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Andrew Eaton
• Organization: University of Toronto

andrew.eaton@utoronto.ca

4169788895

Study Officials

• Sharon L Walmsley, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: March 30, 2018
• Study Start: August 6, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)