E-TIPS: Telehealth Pain Self-Management for Employed Adults

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT04248725

Collaborator

Department of Health and Human Services (U.S. Fed)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Brain Injuries, Traumatic Multiple Sclerosis Spinal Cord Injuries Amputation	Behavioral: E-TIPS	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

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.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)

Primary Purpose:

Treatment

Official Title:

Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults With Physical Disability: A Randomized Controlled Trial

Actual Study Start Date :

Mar 2, 2020

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: E-TIPS 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: E-TIPS

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.

Outcome Measures

Primary Outcome Measures

Change in pain interference [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.

Secondary Outcome Measures

Change in pain self-efficacy [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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