Clinical trial NCT04248725: Telehealth Pain Self-Management for Employed Adults
Official title: Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults With Physical Disability: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Brain Injuries, Traumatic
Multiple Sclerosis
Spinal Cord Injuries
Amputation
Keywords: chronic pain
cognitive therapy
mindfulness meditation
activation skills
pain
employment
telehealth
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2020-01-30
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Pain Interference
timeFrame: Baseline (week 0) and 12 weeks (post-treatment)
Secondary outcomes:
measure: Change in Pain Self-efficacy
timeFrame: Baseline (week 0) and 12 weeks (post-treatment)
measure: Change in Average Pain Intensity
timeFrame: Baseline (week 0) and 12 weeks (post-treatment)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Dawn M Ehde, PhD
role: PRINCIPAL_INVESTIGATOR
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