Trial Outcomes & Findings for Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression (NCT NCT02262377)
NCT ID: NCT02262377
Last Updated: 2019-08-28
Results Overview
Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.
COMPLETED
NA
159 participants
This was conducted at 21 weeks.
2019-08-28
Participant Flow
Participant milestones
| Measure |
Integrative Medical Group Visits
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
|
Standard of Care
primary care visits, which include medications and advice
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
79
|
|
Overall Study
COMPLETED
|
68
|
73
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
| Measure |
Integrative Medical Group Visits
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
|
Standard of Care
primary care visits, which include medications and advice
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Found ineligible after enrollment
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression
Baseline characteristics by cohort
| Measure |
Integrative Medical Group Visits
n=76 Participants
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
|
Standard of Care
n=79 Participants
primary care visits, which include medications and advice
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
51 years
STANDARD_DEVIATION 12.4 • n=107 Participants
|
50.5 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Study Sites
Boston Medical Center
|
33 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Study Sites
Dotwell Health Center
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Study Sites
Codman Square Health Center
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Income
Less than $5K
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Income
$5K-$29.99K
|
36 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Income
$30K and over
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Income
Refused/ DK/ No income
|
25 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Work Status
Full/ Part time
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Work Status
Unemployed
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Work Status
Retired/ Homemaker
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Work Status
Sick Leave/ Disability
|
32 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Work Status
Other
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Education Level
< High school/ some HS
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Education Level
High school degree
|
22 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Education Level
Some college/ AA degree
|
30 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Education Level
College degree or higher
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
REALM-R score
|
6 unit a scale
STANDARD_DEVIATION 2.5 • n=99 Participants
|
6 unit a scale
STANDARD_DEVIATION 2.5 • n=107 Participants
|
6 unit a scale
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Self Reported Substance Abuse
Current Smoker ONLY
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Self Reported Substance Abuse
4 or more alcoholic drinks on one occasion only
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Self Reported Substance Abuse
Illegal drug use only
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Self Reported Substance Abuse
None - smoke, drink, or use illegal drug
|
35 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Self Reported Substance Abuse
use at-leas 2 cigarettes or alcohol, illegal drug
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: This was conducted at 21 weeks.Population: Intention to Treat Analysis Results
Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.
Outcome measures
| Measure |
Integrative Medicine Group Visits
n=68 Participants
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
|
Standard of Care-Control
n=73 Participants
Routine primary care visits, which include medications and advice
|
|---|---|---|
|
Chronic Pain
21 week Average pain
|
6.0 units on a scale
Standard Deviation 2.0
|
6.0 units on a scale
Standard Deviation 2.0
|
|
Chronic Pain
21 week BPI Interference
|
6.0 units on a scale
Standard Deviation 2.7
|
5.0 units on a scale
Standard Deviation 2.7
|
|
Chronic Pain
21 week BPI Severity
|
6.0 units on a scale
Standard Deviation 2.3
|
6.0 units on a scale
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: This was conducted at 21 weeks.Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It is a sum of 9 items each with a 0-3 units on a scale. Higher scores indicate higher levels of depression. A score of 0-4 is considered minimal or none in depression severity. A score of 5-9 is considered mild in depression severity. A score of 10-14 is considered moderate in depression severity. A score of 15-19 is considered moderately severe in depression severity. A score of 20-27 is considered severe in depression severity. (Kroenke 2009) This was conducted at 21 weeks.
Outcome measures
| Measure |
Integrative Medicine Group Visits
n=68 Participants
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
|
Standard of Care-Control
n=73 Participants
Routine primary care visits, which include medications and advice
|
|---|---|---|
|
Depression
|
9.32 units on a scale
Standard Deviation 5.42
|
10.15 units on a scale
Standard Deviation 5.88
|
PRIMARY outcome
Timeframe: This was conducted at 21 weeks.Pain Self Efficacy Questionnaire (PSEQ) - used to assess the confidence in performing activities while in pain. It is the sum of 10 items each with a 0-6 scale. Scores range from 0-60 and is done by simple addition. Higher scores indicate higher levels of confidence. (Nicholas 2007) This was conducted at 21 weeks.
Outcome measures
| Measure |
Integrative Medicine Group Visits
n=68 Participants
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
|
Standard of Care-Control
n=73 Participants
Routine primary care visits, which include medications and advice
|
|---|---|---|
|
Pain Self Efficacy Scale
|
34 units on a scale
Standard Deviation 14.7
|
38 units on a scale
Standard Deviation 13.5
|
PRIMARY outcome
Timeframe: This was conducted at 21 weeks.Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.
Outcome measures
| Measure |
Integrative Medicine Group Visits
n=68 Participants
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
|
Standard of Care-Control
n=73 Participants
Routine primary care visits, which include medications and advice
|
|---|---|---|
|
Pain Medication Use
|
49 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: This was collected at 21 weeks.Number of emergency room visits based on chart review data collection.
Outcome measures
| Measure |
Integrative Medicine Group Visits
n=68 Participants
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
|
Standard of Care-Control
n=73 Participants
Routine primary care visits, which include medications and advice
|
|---|---|---|
|
Emergency Department Use
|
9 participants
|
9 participants
|
Adverse Events
Integrative Medical Group Visits
Standard of Care
All Participants
Serious adverse events
| Measure |
Integrative Medical Group Visits
n=76 participants at risk
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
|
Standard of Care
n=79 participants at risk
primary care visits, which include medications and advice
|
All Participants
n=155 participants at risk
All participants included in the RCT.
|
|---|---|---|---|
|
General disorders
Hospitalization unrelated to study
|
1.3%
1/76 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
1.3%
2/155 • Number of events 2
|
Other adverse events
| Measure |
Integrative Medical Group Visits
n=76 participants at risk
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
Integrative Medicine Group Visits: Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
|
Standard of Care
n=79 participants at risk
primary care visits, which include medications and advice
|
All Participants
n=155 participants at risk
All participants included in the RCT.
|
|---|---|---|---|
|
General disorders
Non Serious Adverse Events
|
25.0%
19/76 • Number of events 22
|
16.5%
13/79 • Number of events 20
|
20.6%
32/155 • Number of events 42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place