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 : December 7, 2020
|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 (12 weeks post-randomization; primary endpoint), and 6-month follow up (38 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), 12 weeks (post-treatment),and 38 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: MBaseline (week 0), 12 weeks (post-treatment),and 38 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.
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 Greenemail@example.com|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Carolyn Green, BFA 206-616-9801 firstname.lastname@example.org|
|Principal Investigator:||Dawn M Ehde, PhD||University of Washington|