Trial Outcomes & Findings for Health Improvement Project - Providence (NCT NCT02886234)
NCT ID: NCT02886234
Last Updated: 2020-01-13
Results Overview
Feasibility - as indicated by the number of patients attending at least 50% of sessions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
post-intervention, 9 to 10 weeks after baseline
Results posted on
2020-01-13
Participant Flow
Prior to being randomized, patients had to complete all baseline activities, which included two months of counting to establish a baseline adherence measure. During this interval, 6 patients withdrew from the study. Thus, 44 patients were randomized (24 to health coaching arm, and 20 to the mindfulness training arm).
Participant milestones
| Measure |
Mindfulness Training (MT)
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
24
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Health Improvement Project - Providence
Baseline characteristics by cohort
| Measure |
Mindfulness Training (MT)
n=20 Participants
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
n=22 Participants
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 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
United States
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: post-intervention, 9 to 10 weeks after baselineFeasibility - as indicated by the number of patients attending at least 50% of sessions
Outcome measures
| Measure |
Mindfulness Training (MT)
n=20 Participants
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
n=22 Participants
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
|---|---|---|
|
Feasibility of Intervention
|
11 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: post-intervention, 9 to 10 weeks after baselinePopulation: 3 participants in the MT arm did not complete the acceptability rating at the post-intervention assessment
Number of patients reporting "very satisfied" or "mostly satisfied" with their intervention
Outcome measures
| Measure |
Mindfulness Training (MT)
n=17 Participants
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
n=22 Participants
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
|---|---|---|
|
Acceptability of the Intervention
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baselineSelf-reported number of missed days of medication
Outcome measures
| Measure |
Mindfulness Training (MT)
n=20 Participants
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
n=22 Participants
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
|---|---|---|
|
Antiretroviral Medication Adherence
Baseline
|
4.20 days
Standard Deviation 7.02
|
1.95 days
Standard Deviation 3.15
|
|
Antiretroviral Medication Adherence
Post-Intervention
|
3.41 days
Standard Deviation 6.57
|
1.64 days
Standard Deviation 3.30
|
|
Antiretroviral Medication Adherence
3-month Follow-up
|
2.70 days
Standard Deviation 3.53
|
1.45 days
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baselineSelf-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome
Outcome measures
| Measure |
Mindfulness Training (MT)
n=20 Participants
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
n=22 Participants
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
|---|---|---|
|
Self-reported Sexual Risk Behavior
Baseline
|
57 percentage of sexual events condom used
Standard Deviation 44
|
32 percentage of sexual events condom used
Standard Deviation 44
|
|
Self-reported Sexual Risk Behavior
post-intervention
|
100 percentage of sexual events condom used
Standard Deviation 236
|
49 percentage of sexual events condom used
Standard Deviation 71
|
|
Self-reported Sexual Risk Behavior
3-month Follow-up
|
71 percentage of sexual events condom used
Standard Deviation 49
|
43 percentage of sexual events condom used
Standard Deviation 48
|
SECONDARY outcome
Timeframe: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baselineFive Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome
Outcome measures
| Measure |
Mindfulness Training (MT)
n=20 Participants
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
n=22 Participants
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire
Baseline
|
47.70 score on a scale
Standard Deviation 7.09
|
49.09 score on a scale
Standard Deviation 8.09
|
|
Five Facet Mindfulness Questionnaire
Post-Intervention
|
53.06 score on a scale
Standard Deviation 10.32
|
52.73 score on a scale
Standard Deviation 8.98
|
|
Five Facet Mindfulness Questionnaire
3-month Follow-up
|
53.05 score on a scale
Standard Deviation 7.49
|
52.18 score on a scale
Standard Deviation 7.84
|
SECONDARY outcome
Timeframe: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baselinePerceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome
Outcome measures
| Measure |
Mindfulness Training (MT)
n=20 Participants
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
n=22 Participants
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
|---|---|---|
|
Perceived Stress Scale
Baseline
|
6.90 score on a scale
Standard Deviation 4.09
|
5.86 score on a scale
Standard Deviation 3.01
|
|
Perceived Stress Scale
post-Intervention
|
6.06 score on a scale
Standard Deviation 3.58
|
5.64 score on a scale
Standard Deviation 2.75
|
|
Perceived Stress Scale
3-month Follow-up
|
5.80 score on a scale
Standard Deviation 3.71
|
5.73 score on a scale
Standard Deviation 3.28
|
SECONDARY outcome
Timeframe: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baselineBarratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome
Outcome measures
| Measure |
Mindfulness Training (MT)
n=20 Participants
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
n=22 Participants
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
|---|---|---|
|
Barratt Impulsiveness Scale
baseline
|
18.15 score on a scale
Standard Deviation 3.76
|
17.50 score on a scale
Standard Deviation 4.36
|
|
Barratt Impulsiveness Scale
post-intervention
|
17.76 score on a scale
Standard Deviation 4.31
|
15.68 score on a scale
Standard Deviation 3.40
|
|
Barratt Impulsiveness Scale
3-month Follow-up
|
16.05 score on a scale
Standard Deviation 4.07
|
16.50 score on a scale
Standard Deviation 4.42
|
SECONDARY outcome
Timeframe: Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baselinePatient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome
Outcome measures
| Measure |
Mindfulness Training (MT)
n=20 Participants
Eight, 30-minute phone delivered MT sessions once a week for 8 weeks
Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
|
Health Coaching (HC)
n=22 Participants
Eight, 30-minute phone delivered HC sessions once a week for 8 weeks
Health Coaching (HC): The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
|
|---|---|---|
|
Patient Health Questionnaire
3-month Follow-up
|
6.90 score on a scale
Standard Deviation 5.23
|
5.18 score on a scale
Standard Deviation 3.72
|
|
Patient Health Questionnaire
Baseline
|
9.80 score on a scale
Standard Deviation 6.58
|
8.55 score on a scale
Standard Deviation 5.54
|
|
Patient Health Questionnaire
Post-Intervention
|
8.82 score on a scale
Standard Deviation 6.66
|
5.68 score on a scale
Standard Deviation 4.82
|
Adverse Events
Mindfulness Training (MT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Coaching (HC)
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