Trial Outcomes & Findings for Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression (NCT 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

159 participants

Primary outcome timeframe

This was conducted at 21 weeks.

Results posted on

2019-08-28

Participant Flow

Participant milestones

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

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

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=5 Participants	51 years STANDARD_DEVIATION 12.4 • n=7 Participants	50.5 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	70 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	67 Participants n=7 Participants	133 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	44 Participants n=5 Participants	43 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Study Sites Boston Medical Center	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Study Sites Dotwell Health Center	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Study Sites Codman Square Health Center	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Income Less than $5K	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Income $5K-$29.99K	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Income $30K and over	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Income Refused/ DK/ No income	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Work Status Full/ Part time	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Work Status Unemployed	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Work Status Retired/ Homemaker	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Work Status Sick Leave/ Disability	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Work Status Other	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Education Level < High school/ some HS	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Education Level High school degree	22 Participants n=5 Participants	31 Participants n=7 Participants	53 Participants n=5 Participants
Education Level Some college/ AA degree	30 Participants n=5 Participants	23 Participants n=7 Participants	53 Participants n=5 Participants
Education Level College degree or higher	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
REALM-R score	6 unit a scale STANDARD_DEVIATION 2.5 • n=5 Participants	6 unit a scale STANDARD_DEVIATION 2.5 • n=7 Participants	6 unit a scale STANDARD_DEVIATION 2.5 • n=5 Participants
Self Reported Substance Abuse Current Smoker ONLY	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Self Reported Substance Abuse 4 or more alcoholic drinks on one occasion only	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Self Reported Substance Abuse Illegal drug use only	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Self Reported Substance Abuse None - smoke, drink, or use illegal drug	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Self Reported Substance Abuse use at-leas 2 cigarettes or alcohol, illegal drug	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: This was conducted at 21 weeks.

Population: Intention to Treat Analysis Results

Outcome measures

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

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

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

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

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

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Standard of Care

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

All Participants

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

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

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

Paula Gardiner

Boston Medical Center

Phone: 414-6267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place