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Behavioral Intervention

E-TIPS for Chronic Pain (E-TIPS Trial)

N/A

Recruiting

Led By Dawn M Ehde, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization

Awards & highlights

E-TIPS Trial Summary

This trial will compare a cognitive-behavioral pain self-management intervention delivered by telephone to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed.

Eligible Conditions

Chronic Pain
Traumatic Brain Injury
Multiple Sclerosis
Spinal Cord Injury
Amputation

E-TIPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in pain interference

Secondary outcome measures

Change in average pain intensity

Change in pain self-efficacy

E-TIPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: E-TIPSExperimental Treatment1 Intervention

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.

Group II: Usual careActive Control1 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.

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Who is running the clinical trial?

University of WashingtonLead Sponsor

1,738 Previous Clinical Trials

1,844,151 Total Patients Enrolled

40 Trials studying Chronic Pain

17,147 Patients Enrolled for Chronic Pain

Department of Health and Human ServicesFED

226 Previous Clinical Trials

928,749 Total Patients Enrolled

Dawn M Ehde, PhDPrincipal InvestigatorUniversity of Washington

1 Previous Clinical Trials

195 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being recruited for this clinical experiment?

"Affirmative. Clinicaltrials.gov exhibits that this trial is actively enlisting patients, with the initial posting being on March 2nd 2020 and the most recent edit occurring July 25th 2022. The study seeks to recruit 200 participants from a single site."

Answered by AI