Psychosocial Intervention for Older HIV+ Adults With HAND (IN-HAND)

• Sponsor: University Health Network, Toronto
• Collaborators: CIHR Canadian HIV Trials Network; St. Michael's Hospital, Toronto; AIDS Committee of Toronto; Factor-Inwentash Faculty of Social Work, University of Toronto
• Information provided by (Responsible Party): University Health Network, Toronto

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV/AIDS; Aging; Mild Cognitive Impairment; Group, Peer	Behavioral: CRGT; Behavioral: HIV group therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Cognitive Remediation Group Therapy to Improve Older Adults' Ability to Cope With HIV-Associated Neurocognitive Disorder (HAND)
• Actual Study Start Date: April 9, 2018
• Estimated Primary Completion Date: October 31, 2018
• Estimated Study Completion Date: December 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cognitive remediation group therapy; 8 weekly 3-hour sessions of CRGT	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.
Active Comparator: Mutual aid support group; 8 weekly 3-hour sessions of HIV group therapy	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility - participant attendance at group sessions [ Time Frame: Three months ]
   The sampling frame is approximately 100 people. The following targets (all based on a denominator of 100) would need to be met for a larger study to be considered feasible: ▁(>)30% of those contacted agree to participate, ▁(>)25% complete the pre-test, ▁(>)20% attend the first session, ▁(>)16% complete the full series and complete the post-test. Each participant must attend 80% (8/10) of the group sessions to be considered as completing the series.
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.

Secondary Outcome Measures :

1. Intervention fidelity - how closely facilitators adhere to intervention model [ Time Frame: Three months ]
   Facilitators of both study arms will submit weekly session reports. These reports will include checklists of the therapy components; use of an average 80% of components listed will be considered as good fidelity. These reports will also include open-ended questions about the sessions, including questions on group dynamics, challenges faced, and detail on activities used.

Other Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Andrew D Eaton, MSW; 4163408484 ext 283; aeaton@actoronto.org

Contact: Sharon L Walmsley, MD; 4163403871; sharon.walmsley@uhn.ca

Locations

Canada, Ontario

AIDS Committee of Toronto (ACT); Not yet recruiting

Toronto, Ontario, Canada, M4Y1Y5

Contact: Galo F Ginocchio gginocchio@actoronto.ca

Principal Investigator: Andrew D Eaton, MSW

St. Michael's Hospital Neurobehavioral Research Unit; Recruiting

Toronto, Ontario, Canada, M5B1M4

Contact: Teri Sota, PhD 4168646060 ext 6484 sotat@smh.ca

Principal Investigator: Sean B Rourke, PhD

University Health Network, Toronto General Hospital; Not yet recruiting

Toronto, Ontario, Canada, M5G 2N2

Contact: Chantale Sheehan Chantale.Sheehan@uhn.ca

Principal Investigator: Sharon Walmsley, MD

Sponsors and Collaborators

University Health Network, Toronto

CIHR Canadian HIV Trials Network

St. Michael's Hospital, Toronto

AIDS Committee of Toronto

Factor-Inwentash Faculty of Social Work, University of Toronto

Investigators

• Principal Investigator: Sharon L Walmsley, MD; University Health Network, Toronto

  Study Documents (Full-Text)

Documents provided by University Health Network, Toronto:

Study Protocol and Statistical Analysis Plan  [PDF] October 31, 2017

Informed Consent Form  [PDF] October 31, 2017

More Information

Additional Information:

Plain language summary 

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT03483740 History of Changes
• Other Study ID Numbers: CTNPT 029
• First Posted: March 30, 2018
• Last Update Posted: April 11, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:

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

Additional relevant MeSH terms:

Cognitive Dysfunction; Neurocognitive Disorders; Cognition Disorders; Mental Disorders