Trial Outcomes & Findings for Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV (NCT NCT03692611)
NCT ID: NCT03692611
Last Updated: 2025-03-19
Results Overview
The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
278 participants
Primary outcome timeframe
Immediately postintervention and 3-month follow-up (postintervention)
Results posted on
2025-03-19
Participant Flow
Participant milestones
| Measure |
Skills to Manage Pain (STOMP)
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
139
|
|
Overall Study
COMPLETED
|
136
|
139
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Skills to Manage Pain (STOMP)
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
Overall Study
Found to be ineligible postrandomization
|
3
|
0
|
Baseline Characteristics
Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV
Baseline characteristics by cohort
| Measure |
Skills to Manage Pain (STOMP)
n=139 Participants
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 Participants
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
53.7 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
275 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/Ethnicity, Customized
Black or African American
|
107 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or American Indian/Alaska Native
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
139 participants
n=5 Participants
|
139 participants
n=7 Participants
|
278 participants
n=5 Participants
|
|
Site
University of Alabama at Birmingham
|
67 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Site
University of North Carolina-Chapel Hill
|
72 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Detectable viral load, >200 copies/mL
No
|
120 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Detectable viral load, >200 copies/mL
Yes
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Detectable viral load, >200 copies/mL
Unknown
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Currently taking any anti-HIV medications
No
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Currently taking any anti-HIV medications
Yes
|
135 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Currently taking any anti-HIV medications
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Brief Pain Inventory (BPI) Total Score
|
6.3 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Pain Severity Subscore
|
6.4 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Brief Pain Inventory (BPI) Functional Interference Subscore
|
6.5 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Taken an opioid or narcotic for pain for 3 months or more
No
|
106 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Taken an opioid or narcotic for pain for 3 months or more
Yes
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Multisite pain (>3 sites of pain)
No
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Multisite pain (>3 sites of pain)
Yes
|
107 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Pain locations
Numbness or tingling in hands and/or feet
|
75 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Pain locations
Headache
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Pain locations
Abdominal
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Pain locations
Lower back
|
109 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Pain locations
Hip
|
64 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Pain locations
Shoulder
|
64 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Pain locations
Knee
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Pain locations
Pain everywhere in the body
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Pain locations
Other
|
65 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Cocaine use history
None
|
69 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Cocaine use history
Past use
|
66 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Cocaine use history
Current use
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Cocaine use history
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
The Pain, Enjoyment and General Activity (PEG) scale
|
7.4 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
The Pain Self-Efficacy Questionnaire (PSEQ)
|
34.6 units on a scale
STANDARD_DEVIATION 13.4 • n=5 Participants
|
32.5 units on a scale
STANDARD_DEVIATION 15.4 • n=7 Participants
|
33.6 units on a scale
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
The Patient Health Questionnaire-8 (PHQ-8)
|
9.1 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 6.1 • n=7 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
The Pain Catastrophizing Scale (PCS)
|
39.8 units on a scale
STANDARD_DEVIATION 13.5 • n=5 Participants
|
39.9 units on a scale
STANDARD_DEVIATION 14.0 • n=7 Participants
|
39.8 units on a scale
STANDARD_DEVIATION 13.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately postintervention and 3-month follow-up (postintervention)The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
Outcome measures
| Measure |
Skills to Manage Pain (STOMP)
n=139 Participants
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 Participants
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
Brief Pain Inventory (BPI) Total Score
Immediately postintervention
|
4.74 score on a scale
Standard Deviation 0.19
|
5.99 score on a scale
Standard Deviation 0.19
|
|
Brief Pain Inventory (BPI) Total Score
3-month follow-up
|
5.13 score on a scale
Standard Deviation 0.19
|
5.74 score on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Immediately postintervention and 3-month follow-up (postintervention)The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
Outcome measures
| Measure |
Skills to Manage Pain (STOMP)
n=139 Participants
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 Participants
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
Brief Pain Inventory (BPI) Functional Interference Subscore
Immediately postintervention
|
4.41 score on a scale
Standard Deviation 0.23
|
5.93 score on a scale
Standard Deviation 0.23
|
|
Brief Pain Inventory (BPI) Functional Interference Subscore
3-month follow-up
|
4.92 score on a scale
Standard Deviation 0.24
|
5.57 score on a scale
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Immediately postintervention and 3-month follow-up (postintervention)The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
Outcome measures
| Measure |
Skills to Manage Pain (STOMP)
n=139 Participants
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 Participants
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
Brief Pain Inventory (BPI) Pain Severity Subscore
Immediately postintervention
|
5.13 score on a scale
Standard Deviation 0.2
|
6.23 score on a scale
Standard Deviation 0.19
|
|
Brief Pain Inventory (BPI) Pain Severity Subscore
3-month follow-up
|
5.25 score on a scale
Standard Deviation 0.2
|
6.11 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Immediately postintervention and 3-month follow-up (postintervention)The Pain, Enjoyment and General Activity (PEG) scale measures pain severity and enjoyment of activities with scores ranging from 0 to 10. Higher scores indicate worse pain and greater interference with daily activities. The total score is the average of 3 items assessing pain intensity, enjoyment of life, and general activity.
Outcome measures
| Measure |
Skills to Manage Pain (STOMP)
n=139 Participants
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 Participants
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
The Pain, Enjoyment and General Activity (PEG) Scale
Immediately postintervention
|
5.61 score on a scale
Standard Deviation 0.21
|
6.94 score on a scale
Standard Deviation 0.2
|
|
The Pain, Enjoyment and General Activity (PEG) Scale
3-month follow-up
|
5.68 score on a scale
Standard Deviation 0.21
|
6.78 score on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Immediately postintervention and 3-month follow-up (postintervention)The Pain Self-Efficacy Questionnaire (PSEQ) assesses an individual's confidence in their ability to perform daily activities despite pain. The total score is the sum of 10 items, each rated from 0 to 6, resulting in a range of 0 to 60. Higher scores indicate greater self-efficacy and a stronger belief in one's ability to manage daily tasks while experiencing pain.
Outcome measures
| Measure |
Skills to Manage Pain (STOMP)
n=139 Participants
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 Participants
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
The Pain Self-Efficacy Questionnaire (PSEQ)
Immediately postintervention
|
40.53 score on a scale
Standard Deviation 1.31
|
36.44 score on a scale
Standard Deviation 1.28
|
|
The Pain Self-Efficacy Questionnaire (PSEQ)
3-month follow-up
|
40.73 score on a scale
Standard Deviation 1.33
|
35.91 score on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Immediately postintervention and 3-month follow-up (postintervention)The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing depressive symptoms over the past two weeks. Each item is rated from 0 to 3, with the total score (0-24) calculated by adding all responses, with higher scores indicating more severe depressive symptoms and a worse mental health outcome.
Outcome measures
| Measure |
Skills to Manage Pain (STOMP)
n=139 Participants
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 Participants
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
The Patient Health Questionnaire-8 (PHQ-8)
Immediately postintervention
|
6.39 score on a scale
Standard Deviation 0.48
|
8.66 score on a scale
Standard Deviation 0.47
|
|
The Patient Health Questionnaire-8 (PHQ-8)
3-month follow-up
|
7.25 score on a scale
Standard Deviation 0.48
|
7.69 score on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Immediately postintervention and 3-month follow-up (postintervention)The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure assessing exaggerated negative thoughts and feelings about pain. Each item is rated from 0 to 4, with the total score (0-52) calculated by summing all responses. Higher scores indicate greater pain catastrophizing and worse psychological outcomes related to pain.
Outcome measures
| Measure |
Skills to Manage Pain (STOMP)
n=139 Participants
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 Participants
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
The Pain Catastrophizing Scale (PCS)
Immediately postintervention
|
34.35 score on a scale
Standard Deviation 1.46
|
38.57 score on a scale
Standard Deviation 1.44
|
|
The Pain Catastrophizing Scale (PCS)
3-month follow-up
|
34.24 score on a scale
Standard Deviation 1.48
|
35.99 score on a scale
Standard Deviation 1.46
|
Adverse Events
Skills to Manage Pain (STOMP)
Serious events: 39 serious events
Other events: 51 other events
Deaths: 0 deaths
Comparison Group
Serious events: 45 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Skills to Manage Pain (STOMP)
n=139 participants at risk
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 participants at risk
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
General disorders
Very Severe
|
2.9%
4/139 • Number of events 4 • 2 years, 7 months
Participants reported adverse events (AEs) during routine assessments and indicated if they were study-related. Study-related AEs were adjudicated by the site PI. All AEs were reported and reviewed in meetings. Events were classified by type (hospitalization, illness, injury) and grouped by severity: mild, moderate, severe, or very severe (see Adverse Event Term Additional Description). AEs were recorded based on participant descriptions rather than predefined Adverse Event Terms.
|
5.0%
7/139 • Number of events 7 • 2 years, 7 months
Participants reported adverse events (AEs) during routine assessments and indicated if they were study-related. Study-related AEs were adjudicated by the site PI. All AEs were reported and reviewed in meetings. Events were classified by type (hospitalization, illness, injury) and grouped by severity: mild, moderate, severe, or very severe (see Adverse Event Term Additional Description). AEs were recorded based on participant descriptions rather than predefined Adverse Event Terms.
|
|
General disorders
Severe
|
25.2%
35/139 • Number of events 35 • 2 years, 7 months
Participants reported adverse events (AEs) during routine assessments and indicated if they were study-related. Study-related AEs were adjudicated by the site PI. All AEs were reported and reviewed in meetings. Events were classified by type (hospitalization, illness, injury) and grouped by severity: mild, moderate, severe, or very severe (see Adverse Event Term Additional Description). AEs were recorded based on participant descriptions rather than predefined Adverse Event Terms.
|
27.3%
38/139 • Number of events 38 • 2 years, 7 months
Participants reported adverse events (AEs) during routine assessments and indicated if they were study-related. Study-related AEs were adjudicated by the site PI. All AEs were reported and reviewed in meetings. Events were classified by type (hospitalization, illness, injury) and grouped by severity: mild, moderate, severe, or very severe (see Adverse Event Term Additional Description). AEs were recorded based on participant descriptions rather than predefined Adverse Event Terms.
|
Other adverse events
| Measure |
Skills to Manage Pain (STOMP)
n=139 participants at risk
The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.
Skills TO Manage Pain (STOMP): 12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
|
Comparison Group
n=139 participants at risk
The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.
comparison group: Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
|
|---|---|---|
|
General disorders
Moderate
|
21.6%
30/139 • Number of events 30 • 2 years, 7 months
Participants reported adverse events (AEs) during routine assessments and indicated if they were study-related. Study-related AEs were adjudicated by the site PI. All AEs were reported and reviewed in meetings. Events were classified by type (hospitalization, illness, injury) and grouped by severity: mild, moderate, severe, or very severe (see Adverse Event Term Additional Description). AEs were recorded based on participant descriptions rather than predefined Adverse Event Terms.
|
24.5%
34/139 • Number of events 34 • 2 years, 7 months
Participants reported adverse events (AEs) during routine assessments and indicated if they were study-related. Study-related AEs were adjudicated by the site PI. All AEs were reported and reviewed in meetings. Events were classified by type (hospitalization, illness, injury) and grouped by severity: mild, moderate, severe, or very severe (see Adverse Event Term Additional Description). AEs were recorded based on participant descriptions rather than predefined Adverse Event Terms.
|
|
General disorders
Mild
|
15.1%
21/139 • Number of events 21 • 2 years, 7 months
Participants reported adverse events (AEs) during routine assessments and indicated if they were study-related. Study-related AEs were adjudicated by the site PI. All AEs were reported and reviewed in meetings. Events were classified by type (hospitalization, illness, injury) and grouped by severity: mild, moderate, severe, or very severe (see Adverse Event Term Additional Description). AEs were recorded based on participant descriptions rather than predefined Adverse Event Terms.
|
12.9%
18/139 • Number of events 18 • 2 years, 7 months
Participants reported adverse events (AEs) during routine assessments and indicated if they were study-related. Study-related AEs were adjudicated by the site PI. All AEs were reported and reviewed in meetings. Events were classified by type (hospitalization, illness, injury) and grouped by severity: mild, moderate, severe, or very severe (see Adverse Event Term Additional Description). AEs were recorded based on participant descriptions rather than predefined Adverse Event Terms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place