Trial Outcomes & Findings for Telehealth Pain Self-Management for Employed Adults (NCT NCT04248725)
NCT ID: NCT04248725
Last Updated: 2025-01-24
Results Overview
Patient-reported pain interference using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale-6-item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score. The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater self-reported pain interference.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
220 participants
Primary outcome timeframe
Baseline (week 0) and 12 weeks (post-treatment)
Results posted on
2025-01-24
Participant Flow
Of the 220 enrolled participants, 8 were excluded prior to the baseline assessment because they were not able to be contacted for baseline completion. After 212 enrolled participants completed the baseline assessment, 10 additional participants were excluded because: we were unable to contact them for randomization (n=5), they withdrew from the study due to personal circumstances (n=3), or withdrawn by staff (n=2). A total of 202 were randomized to one of the two study arms.
Participant milestones
| Measure |
E-TIPS
The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home.
E-TIPS: Chronic pain self-management strategies for employed individuals with physical disabilities
|
Usual Care
Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment.
|
|---|---|---|
|
Post-Treatment
STARTED
|
102
|
100
|
|
Post-Treatment
COMPLETED
|
96
|
95
|
|
Post-Treatment
NOT COMPLETED
|
6
|
5
|
|
6-Month Follow Up
STARTED
|
102
|
100
|
|
6-Month Follow Up
COMPLETED
|
93
|
92
|
|
6-Month Follow Up
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
E-TIPS
The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home.
E-TIPS: Chronic pain self-management strategies for employed individuals with physical disabilities
|
Usual Care
Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment.
|
|---|---|---|
|
Post-Treatment
Lost to Follow-up
|
6
|
5
|
|
6-Month Follow Up
Lost to Follow-up
|
9
|
8
|
Baseline Characteristics
Telehealth Pain Self-Management for Employed Adults
Baseline characteristics by cohort
| Measure |
E-TIPS
n=102 Participants
The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home.
E-TIPS: Chronic pain self-management strategies for employed individuals with physical disabilities
|
Usual Care
n=100 Participants
Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 12 • n=5 Participants
|
46 years
STANDARD_DEVIATION 12 • n=7 Participants
|
46 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
71 participants
n=5 Participants
|
70 participants
n=7 Participants
|
141 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Sex/Gender, Customized
Man
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Sex/Gender, Customized
Woman
|
69 participants
n=5 Participants
|
65 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex/Gender, Customized
Prefer not to answer/unknown
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
100 participants
n=7 Participants
|
202 participants
n=5 Participants
|
|
Disability condition
Multiple sclerosis
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Disability condition
Spinal cord injury
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Disability condition
Traumatic brain injury
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Disability condition
Amputation
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Disability condition
Multiple diagnoses
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0) and 12 weeks (post-treatment)Patient-reported pain interference using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale-6-item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score. The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater self-reported pain interference.
Outcome measures
| Measure |
E-TIPS
n=102 Participants
The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home.
E-TIPS: Chronic pain self-management strategies for employed individuals with physical disabilities
|
Usual Care
n=100 Participants
Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment.
|
|---|---|---|
|
Change in Pain Interference
|
-4.0 T-score
Interval -8.5 to 0.1
|
-1.3 T-score
Interval -5.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline (week 0) and 12 weeks (post-treatment)Patient-reported pain self-efficacy for managing pain using the University of Washington Pain Self-Efficacy Scale-6 item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score.The population mean is a score of 50, with a standard deviation of 10. Higher scores indicate greater patient-reported self-efficacy for managing pain.
Outcome measures
| Measure |
E-TIPS
n=102 Participants
The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home.
E-TIPS: Chronic pain self-management strategies for employed individuals with physical disabilities
|
Usual Care
n=100 Participants
Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment.
|
|---|---|---|
|
Change in Pain Self-efficacy
|
5.5 T-score
Standard Deviation 8.2
|
0.9 T-score
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline (week 0) and 12 weeks (post-treatment)0-10 Numerical Pain Rating Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity; range of 0 - 10.
Outcome measures
| Measure |
E-TIPS
n=102 Participants
The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home.
E-TIPS: Chronic pain self-management strategies for employed individuals with physical disabilities
|
Usual Care
n=100 Participants
Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment.
|
|---|---|---|
|
Change in Average Pain Intensity
|
-0.9 units on a scale
Standard Deviation 1.9
|
-0.3 units on a scale
Standard Deviation 1.7
|
Adverse Events
E-TIPS
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E-TIPS
n=102 participants at risk
The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home.
E-TIPS: Chronic pain self-management strategies for employed individuals with physical disabilities
|
Usual Care
n=100 participants at risk
Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Strained muscle
|
0.98%
1/102 • Number of events 1 • 6 months
Adverse events were identified during intervention sessions and assessments.
|
0.00%
0/100 • 6 months
Adverse events were identified during intervention sessions and assessments.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place