Telehealth Pain Self-Management for Employed Adults (E-TIPS)
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|ClinicalTrials.gov Identifier: NCT04248725|
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : July 28, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Brain Injuries, Traumatic Multiple Sclerosis Spinal Cord Injuries Amputation||Behavioral: E-TIPS||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults With Physical Disability: A Randomized Controlled Trial|
|Actual Study Start Date :||March 2, 2020|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||September 1, 2023|
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.
Chronic pain self-management strategies for employed individuals with physical disabilities
No Intervention: 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.
- Change in pain interference [ Time Frame: Baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization ]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. Higher scores indicate greater self-reported pain interference.
- Change in pain self-efficacy [ Time Frame: Baseline (week 0), 10 weeks (post-treatment),and 25 week (6-month follow up) post-randomization ]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. Higher scores indicate greater patient-reported self-efficacy for managing pain.
- Change in average pain intensity [ Time Frame: Baseline (week 0), 10 weeks (post-treatment),and 25 week (6-month follow up) post-randomization ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 18 years of age or older
- Self-reported physical disability
- Chronic pain defined as daily pain of ≥ 3 months duration and ≥ 3 average pain intensity in the past week on a 0-10 numerical rating scale
- Experiences pain for more than 45 out of the past 90 days (defined as 50% of the time or greater)
- Reads, speaks, and understands English
- Has access to and is able to communicate over the telephone with our without assistive devices
- Is employed, working 15-20 hours per week or more, on average, or earning in excess of substantial gainful activity (approximately $1200/month)
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
- Under the age of 18
- Cannot read, speak, or understand English
- No self-reported physical disability
- Currently unemployed
- Plans to retire or leave employment within the study period
- Working fewer than 15-20 hours per week, on average, and earning less than approximately $1200 per month
- Cannot communicate or complete assessments over the phone or internet
- Chronic pain defined as daily pain of ≤ 3 months duration and ≤ 3 average pain intensity in the past week on a 0-10 numerical rating scale
- Experiences pain for fewer than 45 out of the past 90 days (defined as 50% of the time or less)
- Currently participating in another pain study or cognitive behavioral therapy (CBT) study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248725
|Contact: Carolyn C Greenfirstname.lastname@example.org|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Carolyn Green, BFA 206-616-9801 email@example.com|
|Principal Investigator:||Dawn M Ehde, PhD||University of Washington|
|Responsible Party:||Dawn Ehde, Professor, School of Medicine: Rehabilitation Medicine:Psychology, University of Washington|
|Other Study ID Numbers:||
7258 ( Other Grant/Funding Number: DHHS )
|First Posted:||January 30, 2020 Key Record Dates|
|Last Update Posted:||July 28, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||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).|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||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.
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal Cord Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Central Nervous System Diseases
Trauma, Nervous System
Spinal Cord Diseases