Trial Outcomes & Findings for Psychosocial Intervention for Older HIV+ Adults With HAND (NCT NCT03483740)
NCT ID: NCT03483740
Last Updated: 2024-03-29
Results Overview
Number of Participants who Attended at least 80% of the Group Sessions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Three months
Results posted on
2024-03-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychosocial Intervention for Older HIV+ Adults With HAND
Baseline characteristics by cohort
| Measure |
Cognitive Remediation Group Therapy
n=6 Participants
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.
|
Mutual Aid Support Group
n=6 Participants
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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 6.72 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 10.63 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 8.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three monthsNumber of Participants who Attended at least 80% of the Group Sessions.
Outcome measures
| Measure |
Cognitive Remediation Group Therapy
n=6 Participants
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.
|
Mutual Aid Support Group
n=6 Participants
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.
|
|---|---|---|
|
Feasibility - Session Attendance
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Three monthsParticipants 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.
Outcome measures
| Measure |
Cognitive Remediation Group Therapy
n=6 Participants
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.
|
Mutual Aid Support Group
n=6 Participants
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.
|
|---|---|---|
|
Acceptability - Participant Satisfaction With Group Sessions
|
90 score on a scale
Interval 74.0 to 100.0
|
85 score on a scale
Interval 58.0 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21)Self-report at three time points
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline visit (week -1), follow-up visit (week 9), and end of study visit (week 21). Score from 0 to 26Assessed by the 'Five Facet Mindfulness Questionnaire - Short Form' at three time points. Score from 24 to 120. Higher scores mean better outcomes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Cognitive Remediation Group Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mutual Aid Support Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place