Aging, Group, Peer, HIV/AIDS, Mild Cognitive Impairment
Conditions
Keywords
HIV-Associated Neurocognitive Disorder (HAND), Cognitive remediation group therapy, Mutual aid group therapy
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.
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.
Interventions
BEHAVIORALCRGT
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.
BEHAVIORALHIV 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.
Sponsors
CIHR Canadian HIV Trials Network
Unity Health Toronto
AIDS Committee of Toronto
Factor-Inwentash Faculty of Social Work, University of Toronto
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Session Attendance | Three months | Number of Participants who Attended at least 80% of the Group Sessions. |
| Acceptability - Participant Satisfaction With Group Sessions | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Assessed by the 'Five Facet Mindfulness Questionnaire - Short Form' at three time points. Score from 24 to 120. Higher scores mean better outcomes. |
| Change in Stress | 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. |
| Change in Coping | 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. |
| Change in Anxiety | 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. |
| Sustained Use of Brain Training Activities | Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21) | Self-report at three time points |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Remediation Group Therapy 8 weekly 3-hour sessions of CRGT
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. | 6 |
| Mutual Aid Support Group 8 weekly 3-hour sessions of HIV group therapy
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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Cognitive Remediation Group Therapy | Total | Mutual Aid Support Group |
|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 6.72 | 55.6 years STANDARD_DEVIATION 8.68 | 59.7 years STANDARD_DEVIATION 10.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 4 Participants |
| Region of Enrollment Canada | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: Three months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cognitive Remediation Group Therapy | Acceptability - Participant Satisfaction With Group Sessions | 90 score on a scale |
| Mutual Aid Support Group | Acceptability - Participant Satisfaction With Group Sessions | 85 score on a scale |
Primary
Feasibility - Session Attendance
Number of Participants who Attended at least 80% of the Group Sessions.
Time frame: Three months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cognitive Remediation Group Therapy | Feasibility - Session Attendance | 5 Participants |
| Mutual Aid Support Group | Feasibility - Session Attendance | 5 Participants |
Other Pre-specified
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.
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Other Pre-specified
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.
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Other Pre-specified
Change in Stress
Assessed by the 'HIV/AIDS Stress Scale' at three time points. Score from 0 to 116. Lower scores mean better outcomes.
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Other Pre-specified
Sustained Use of Brain Training Activities
Self-report at three time points
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)
Other Pre-specified
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.
Time frame: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21). Score from 0 to 26