Telehealth Pain Self-Management for Employed Adults

NCT04248725 | Completed Results

• 3 other identifiers: STUDY00005686A13350790RTEM0001-01-00
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Brain Injuries, Traumatic; Multiple Sclerosis; Spinal Cord Injuries; Amputation

Keywords

chronic pain; cognitive therapy; mindfulness meditation; activation skills; pain; employment; telehealth

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Change in Pain Self-efficacy

  Baseline (week 0) and 12 weeks (post-treatment)

• Change in Average Pain Intensity

  Baseline (week 0) and 12 weeks (post-treatment)

Study Arms (2)

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.

Behavioral: E-TIPS

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.

Interventions

E-TIPS BEHAVIORAL

Chronic pain self-management strategies for employed individuals with physical disabilities

E-TIPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (14)

• 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.

  PMID: 12514452 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.

  PMID: 19533517 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.

  PMID: 10943752 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.

  PMID: 28652067 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.

  PMID: 18546344 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.

  PMID: 25331746 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.

  PMID: 23713732 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.

  PMID: 21680251 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.

  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.

  PMID: 17928147 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.

  PMID: 12048417 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.

  PMID: 24547801 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.

  PMID: 23701698 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Brain Injuries, Traumatic; Multiple Sclerosis; Spinal Cord Injuries; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases

Results Point of Contact

• Title: Dawn Ehde, PhD
• Organization: University of Washington

ehde@uw.edu

206-591-3780

Study Officials

• Dawn M Ehde, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Rehabilitation Medicine:Psychology

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 30, 2020
• Study Start: March 2, 2020
• Primary Completion: September 30, 2023
• Study Completion: March 1, 2024
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: on or or before October 1, 2024
• Access Criteria: 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.

Locations

US (1)