Trial Outcomes & Findings for Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults (NCT NCT02626949)
NCT ID: NCT02626949
Last Updated: 2022-05-09
Results Overview
Interleukin 6 (IL-6) biological markers at 8 weeks and 6 months as compared to baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Baseline, 8 weeks post intervention, and 6 months post intervention
Results posted on
2022-05-09
Participant Flow
114 were randomized prior to enrollment with final participants enrollment of 84.
Participant milestones
| Measure |
MBSR Course
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
|
HAEP Course
Health \& Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
|
|---|---|---|
|
Randomization, Pre-Enrollment
STARTED
|
56
|
58
|
|
Randomization, Pre-Enrollment
COMPLETED
|
40
|
44
|
|
Randomization, Pre-Enrollment
NOT COMPLETED
|
16
|
14
|
|
Enrolled
STARTED
|
40
|
44
|
|
Enrolled
COMPLETED
|
30
|
36
|
|
Enrolled
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
MBSR Course
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
|
HAEP Course
Health \& Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
|
|---|---|---|
|
Randomization, Pre-Enrollment
did not attend the baseline interview
|
15
|
11
|
|
Randomization, Pre-Enrollment
did not meet inclusion criteria post-randomization
|
1
|
3
|
|
Enrolled
Lost to Follow-up
|
7
|
6
|
|
Enrolled
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Effects of Mindfulness Training on Chronic Inflammation in HIV-Infected Adults
Baseline characteristics by cohort
| Measure |
MBSR Course
n=40 Participants
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
|
HAEP Course
n=44 Participants
Health \& Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
PRIMARY outcome
Timeframe: Baseline, 8 weeks post intervention, and 6 months post interventionPopulation: One participant did not have data for baseline. Data for those participants who completed the 8 weeks and 6 months post-intervention included.
Interleukin 6 (IL-6) biological markers at 8 weeks and 6 months as compared to baseline.
Outcome measures
| Measure |
MBSR Course
n=40 Participants
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
|
HAEP Course
n=44 Participants
Health \& Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
|
|---|---|---|
|
Interleukin 6 (IL-6) Biological Markers
Baseline
|
2.24 pg/mL
Interval 1.48 to 3.69
|
2.63 pg/mL
Interval 1.41 to 3.7
|
|
Interleukin 6 (IL-6) Biological Markers
8 weeks (post intervention)
|
2.53 pg/mL
Interval 1.73 to 4.34
|
2.88 pg/mL
Interval 1.59 to 3.75
|
|
Interleukin 6 (IL-6) Biological Markers
6 months (post intervention)
|
2.89 pg/mL
Interval 1.61 to 5.69
|
2.62 pg/mL
Interval 1.39 to 4.91
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks post intervention, and 6 months post interventionPopulation: Data for those participants who completed the 8 weeks and 6 months post-intervention included.
Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Measures of Psychosocial Stress, total scale 5-40 with higher score indicating more anxiety
Outcome measures
| Measure |
MBSR Course
n=40 Participants
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
|
HAEP Course
n=44 Participants
Health \& Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
|
|---|---|---|
|
PROMIS - Anxiety
Baseline
|
18.7 score on a scale
Standard Deviation 8.2
|
19.3 score on a scale
Standard Deviation 6.9
|
|
PROMIS - Anxiety
8 weeks post intervention
|
15.1 score on a scale
Standard Deviation 6.6
|
18.4 score on a scale
Standard Deviation 7.4
|
|
PROMIS - Anxiety
6 months post intervention
|
15.9 score on a scale
Standard Deviation 6.9
|
18.5 score on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks post intervention, and 6 months post interventionPopulation: Data for those participants who completed the 8 weeks and 6 months post-intervention included.
Patient Reported Outcomes Measurement Information System (PROMIS) - Fatigue - Measures of Psychosocial Stress, total scale 5-40 with higher score indicating more fatigue
Outcome measures
| Measure |
MBSR Course
n=40 Participants
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
|
HAEP Course
n=44 Participants
Health \& Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
|
|---|---|---|
|
PROMIS - Fatigue
6 months post intervention
|
18.8 score on a scale
Standard Deviation 8.0
|
19.3 score on a scale
Standard Deviation 9.6
|
|
PROMIS - Fatigue
Baseline
|
21.2 score on a scale
Standard Deviation 8.1
|
21.4 score on a scale
Standard Deviation 9.4
|
|
PROMIS - Fatigue
8 weeks post intervention
|
16.8 score on a scale
Standard Deviation 7.7
|
21.1 score on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks post intervention, and 6 months post interventionPopulation: Data for those participants who completed the 8 weeks and 6 months post-intervention included.
Beck Depression Inventory (BDI-II) - Measures of Psychosocial Stress, total scale from 0-63, with higher score indicating more depression
Outcome measures
| Measure |
MBSR Course
n=40 Participants
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
|
HAEP Course
n=44 Participants
Health \& Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
|
|---|---|---|
|
BDI-II
Baseline
|
15.0 score on a scale
Standard Deviation 10.0
|
15.6 score on a scale
Standard Deviation 10.6
|
|
BDI-II
8 weeks post intervention
|
9.7 score on a scale
Standard Deviation 9.8
|
14.7 score on a scale
Standard Deviation 10.6
|
|
BDI-II
6 months post intervention
|
9.7 score on a scale
Standard Deviation 7.8
|
13.1 score on a scale
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks post intervention, and 6 months post interventionPopulation: Data for those participants who completed the 8 weeks and 6 months post-intervention included.
The Five Facet Mindfulness Questionnaire (FFMQ) - Measures of Mindfulness, full scale from 39 - 195, with higher score indicating more mindfulness
Outcome measures
| Measure |
MBSR Course
n=40 Participants
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
|
HAEP Course
n=44 Participants
Health \& Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
|
|---|---|---|
|
FFMQ
Baseline
|
135.7 score on a scale
Standard Deviation 21.8
|
135.4 score on a scale
Standard Deviation 19.8
|
|
FFMQ
8 weeks post intervention
|
144.3 score on a scale
Standard Deviation 18.6
|
134.7 score on a scale
Standard Deviation 22.3
|
|
FFMQ
6 months post intervention
|
145.3 score on a scale
Standard Deviation 19.2
|
141.5 score on a scale
Standard Deviation 23.0
|
SECONDARY outcome
Timeframe: 6 monthsAttendance records will provide retention rates.
Outcome measures
| Measure |
MBSR Course
n=40 Participants
Mindfulness-Based Stress Reduction Course (MBSR) consisting of 8 weekly sessions, 2 hours each, and a 5 hour silent retreat during the 6th week of the program.
|
HAEP Course
n=44 Participants
Health \& Arts Enrichment Program (HAEP) consisting of 8 weekly sessions, 2 hours each, and 5 hour educational session during the 6th week of the program.
|
|---|---|---|
|
Retention Rates
|
30 Participants
|
36 Participants
|
Adverse Events
MBSR Course
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HAEP Course
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
Jeffrey Weiss, PhD, MS
Icahn School of Medicine at Mount Sinai
Phone: 212-824-7575
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place