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| ID | Type | Description | Link |
|---|---|---|---|
| A133507 | Other Grant/Funding Number | NIDILRR | |
| 90RTEM0001-01-00 | Other Grant/Funding Number | ShirleyRyan Ability Lab |
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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a waitlist control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.
Chronic pain is one of the most prevalent, disabling, and persistent comorbid conditions associated with physical disabilities, including limb loss, spinal cord injury, traumatic brain injury, and chronic neurodegenerative conditions such as multiple sclerosis. One half to two-thirds of adults with these conditions experience chronic pain. In addition to being associated with disability, depression, sleep disruption, and physical inactivity, chronic pain has deleterious social and societal costs, including job loss and reliance on long-term disability programs.
The E-TIPS intervention aims to address common barriers encountered by employed individuals with chronic pain. People with physical disabilities may be offered face-to-face delivery of pain self-management interventions, in clinical settings during business hours, which limits access to people with physical disabilities who are employed. These individuals must take time off work to attend multiple treatment sessions, overcome transportation difficulties, and contend with the stigma of seeking behavioral healthcare. Telehealth interventions, such as E-TIPS, have considerable potential for expanding the reach of pain self-management interventions for employed people with physical disabilities.
The proposed randomized (1:1), single-blind parallel-group trial will compare the E-TIPS telehealth pain self-management intervention to a waitlist control in adults with physical disabilities and chronic pain who are employed. Outcomes will be assessed before randomization, mid-treatment (6 weeks post-randomization), post-treatment (10 weeks post-randomization; primary endpoint), and 6-month follow up (25 weeks post-randomization). Participants will be recruited from across the US, including at University of Washington (UW) and Shirley Ryan AbilityLab (SRALab).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-TIPS | Experimental | 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. |
|
| Usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-TIPS | Behavioral | Chronic pain self-management strategies for employed individuals with physical disabilities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Interference | 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. | Baseline (week 0) and 12 weeks (post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Self-efficacy | 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. |
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Inclusion Criteria:
We will enroll individuals with a range of physical disabilities to maximize the generalizability of the results, because there is no evidence that the type of disability affects responsiveness to the proposed treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn M Ehde, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12514452 | Background | Ehde DM, Jensen MP, Engel JM, Turner JA, Hoffman AJ, Cardenas DD. Chronic pain secondary to disability: a review. Clin J Pain. 2003 Jan-Feb;19(1):3-17. doi: 10.1097/00002508-200301000-00002. | |
| 19533517 | Background | Dijkers M, Bryce T, Zanca J. Prevalence of chronic pain after traumatic spinal cord injury: a systematic review. J Rehabil Res Dev. 2009;46(1):13-29. |
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All collected IPD will be deposited in a digital data repository. Direct and indirect identifiers will be removed to minimize disclosure risk. The data will be deposited with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR).
on or or before October 1, 2024
Data will be stored in a manner that enables retrieval and use at no cost to users. Each data set will use a Digital Object Identifier (DOI) for future reference and citation. Data submitted to ICPSR, will fit within the scope of the ICPSR Collection Development Policy found at this site: https://www.icpsr.umich.edu/icpsrweb/content/datamanagement/policies/colldev.html.
ICPSR will make the research data from this project available to the broader social science research community. These files, in which direct and indirect identifiers have been removed to minimize disclosure risk, will be accessible directly through the ICPSR Web site. After agreeing to Terms of Use, users with an ICPSR MyData account may download the data at no cost.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Post-Treatment |
|
| ||||||||||||||||||
| 6-Month Follow Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Interference | 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. | Posted | Mean | 95% Confidence Interval | T-score | Baseline (week 0) and 12 weeks (post-treatment) |
|
6 months
Adverse events were identified during intervention sessions and assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Strained muscle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | While practicing progressive muscle relaxation, a participant overdid it and strained a muscle, leading to a temporary increase in pain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Ehde, PhD | University of Washington | 206-591-3780 | ehde@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 4, 2023 | Sep 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2024 | Dec 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000070642 | Brain Injuries, Traumatic |
| D009103 | Multiple Sclerosis |
| D013119 | Spinal Cord Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
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A randomized (1:1), single blind parallel-group trial comparing a telehealth pain self-management intervention, adapted to address employment issues (E-TIPS), to a waitlist control in adults with physical disabilities and chronic pain who are employed.
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Not provided
Not provided
| Baseline (week 0) and 12 weeks (post-treatment) |
| Change in Average Pain Intensity | 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. | Baseline (week 0) and 12 weeks (post-treatment) |
| 10943752 | Background | Ehde DM, Czerniecki JM, Smith DG, Campbell KM, Edwards WT, Jensen MP, Robinson LR. Chronic phantom sensations, phantom pain, residual limb pain, and other regional pain after lower limb amputation. Arch Phys Med Rehabil. 2000 Aug;81(8):1039-44. doi: 10.1053/apmr.2000.7583. |
| 28652067 | Background | Krause JS, Cao Y, Clark JMR. Pain Intensity, Interference, and Medication Use After Spinal Cord Injury: Association With Risk of Mortality After Controlling for Socioeconomic and Other Health Factors. Arch Phys Med Rehabil. 2017 Dec;98(12):2464-2470. doi: 10.1016/j.apmr.2017.05.024. Epub 2017 Jun 23. |
| 18546344 | Background | Negre-Pages L, Regragui W, Bouhassira D, Grandjean H, Rascol O; DoPaMiP Study Group. Chronic pain in Parkinson's disease: the cross-sectional French DoPaMiP survey. Mov Disord. 2008 Jul 30;23(10):1361-9. doi: 10.1002/mds.22142. |
| 25331746 | Background | Franklin GM, Wickizer TM, Coe NB, Fulton-Kehoe D. Workers' compensation: poor quality health care and the growing disability problem in the United States. Am J Ind Med. 2015 Mar;58(3):245-51. doi: 10.1002/ajim.22399. Epub 2014 Oct 20. |
| 23713732 | Background | Alschuler KN, Ehde DM, Jensen MP. The co-occurrence of pain and depression in adults with multiple sclerosis. Rehabil Psychol. 2013 May;58(2):217-21. doi: 10.1037/a0032008. |
| 21680251 | Background | Kroenke K, Wu J, Bair MJ, Krebs EE, Damush TM, Tu W. Reciprocal relationship between pain and depression: a 12-month longitudinal analysis in primary care. J Pain. 2011 Sep;12(9):964-73. doi: 10.1016/j.jpain.2011.03.003. Epub 2011 Jun 16. |
| Background | Anand P, Ben-Shalom Y. The promise of better economic outcomes for workers with musculoskeletal conditions. Roosevelt House: Public Policy Institute at Hunter College.2017. |
| Background | Social Security Administration. Annual Statistical Report on the Social Security Disability Insurance Program, 2015. Washington, DC2016. |
| 17928147 | Background | O'Connor AB, Schwid SR, Herrmann DN, Markman JD, Dworkin RH. Pain associated with multiple sclerosis: systematic review and proposed classification. Pain. 2008 Jul;137(1):96-111. doi: 10.1016/j.pain.2007.08.024. Epub 2007 Oct 24. |
| 12048417 | Background | Warms CA, Turner JA, Marshall HM, Cardenas DD. Treatments for chronic pain associated with spinal cord injuries: many are tried, few are helpful. Clin J Pain. 2002 May-Jun;18(3):154-63. doi: 10.1097/00002508-200205000-00004. |
| 24547801 | Background | Ehde DM, Dillworth TM, Turner JA. Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Am Psychol. 2014 Feb-Mar;69(2):153-66. doi: 10.1037/a0035747. |
| 23701698 | Background | Clarke G, Yarborough BJ. Evaluating the promise of health IT to enhance/expand the reach of mental health services. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):339-44. doi: 10.1016/j.genhosppsych.2013.03.013. Epub 2013 May 20. |
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disability condition | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Secondary | Change in Pain Self-efficacy | 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. | Posted | Mean | Standard Deviation | T-score | Baseline (week 0) and 12 weeks (post-treatment) |
|
|
|
|
| Secondary | Change in Average Pain Intensity | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (week 0) and 12 weeks (post-treatment) |
|
|
|
|
| 0 |
| 102 |
| 1 |
| 102 |
| 0 |
| 102 |
| EG001 | 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. | 0 | 100 | 0 | 100 | 0 | 100 |
|
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013118 | Spinal Cord Diseases |