Trial Outcomes & Findings for Pilot Study of Combined Treatment for Veterans With Chronic Pain & Opiate Misuse (NCT NCT02423772)
NCT ID: NCT02423772
Last Updated: 2024-11-08
Results Overview
The PROMIS pain behavior (PROMIS short form v1.1 7a) measures self-reported frequency of verbal and nonverbal behaviors indicating that one is experiencing pain. It consists of 7 items with scores ranging from 7 to 35 with higher scores indicating more frequent pain behavior.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months post randomization (6 months post end of intervention period).
Results posted on
2024-11-08
Participant Flow
Participant milestones
| Measure |
Intervention
Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.
Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU).
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
Treatment as Usual
Physician directed care through a VA co-occurring disorders clinic that primarily provided medical oversight of opioid prescription and directed patients to other necessary pain interventions.
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
Received Allocated Intervention
|
15
|
13
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Intervention
Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.
Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU).
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
Treatment as Usual
Physician directed care through a VA co-occurring disorders clinic that primarily provided medical oversight of opioid prescription and directed patients to other necessary pain interventions.
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Did not begin intervention
|
2
|
5
|
Baseline Characteristics
Pilot Study of Combined Treatment for Veterans With Chronic Pain & Opiate Misuse
Baseline characteristics by cohort
| Measure |
Intervention
n=17 Participants
Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.
Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU).
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
Treatment as Usual
n=18 Participants
Physician directed care through a VA co-occurring disorders clinic that primarily provided medical oversight of opioid prescription and directed patients to other necessary pain interventions.
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
48.3 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
53.3 Years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
50.5 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months post randomization (6 months post end of intervention period).Population: Per protocol analysis
The PROMIS pain behavior (PROMIS short form v1.1 7a) measures self-reported frequency of verbal and nonverbal behaviors indicating that one is experiencing pain. It consists of 7 items with scores ranging from 7 to 35 with higher scores indicating more frequent pain behavior.
Outcome measures
| Measure |
Intervention
n=17 Participants
Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.
Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU).
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
Treatment as Usual
n=18 Participants
Physician directed care through a VA co-occurring disorders clinic that primarily provided medical oversight of opioid prescription and directed patients to other necessary pain interventions.
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior
Baseline
|
66.7 units on a scale
Standard Deviation 6.6
|
66.0 units on a scale
Standard Deviation 6.6
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior
6 month follow-up
|
64.3 units on a scale
Standard Deviation 9.2
|
66.8 units on a scale
Standard Deviation 8.0
|
PRIMARY outcome
Timeframe: Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months post randomization (6 months post end of intervention period).Population: Per protocol analysis
The PROMIS pain interference Short Form 8a assesses the impact of pain on important aspects of social, physical, cognitive, and recreational activities. It consists of 8 items and scores range from 8 to 40 with higher scores indicating greater pain interference.
Outcome measures
| Measure |
Intervention
n=17 Participants
Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.
Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU).
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
Treatment as Usual
n=18 Participants
Physician directed care through a VA co-occurring disorders clinic that primarily provided medical oversight of opioid prescription and directed patients to other necessary pain interventions.
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference
Baseline
|
66.7 units on a scale
Standard Deviation 6.6
|
65.2 units on a scale
Standard Deviation 6.8
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference
6 month follow-up
|
64.3 units on a scale
Standard Deviation 9.2
|
70.1 units on a scale
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months post randomization (6 monthsPopulation: Per protocol analysis
Total Score of the COMM was used. The COMM is a 17-item measure designed to aid in the identification of opioid misuse. Scores range from 0 to 68 with higher scores indicating greater risk of misuse.
Outcome measures
| Measure |
Intervention
n=17 Participants
Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use.
Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU).
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
Treatment as Usual
n=18 Participants
Physician directed care through a VA co-occurring disorders clinic that primarily provided medical oversight of opioid prescription and directed patients to other necessary pain interventions.
Assessment at randomization, post-intervention (12 weeks post randomization), and six month follow-up (9 months post randomization; 6 months after end of intervention).
|
|---|---|---|
|
Current Opioid Misuse Measure (COMM)
Baseline
|
16.2 units on a scale
Standard Deviation 8.8
|
17.4 units on a scale
Standard Deviation 7.8
|
|
Current Opioid Misuse Measure (COMM)
6 month follow-up
|
10.6 units on a scale
Standard Deviation 6.5
|
16.1 units on a scale
Standard Deviation 8.5
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
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