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Internet-based Pain Self-management for Persons With Acute Recurrent and Chronic Pancreatitis Pain

NCT03322644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-09-27

No results posted yet for this study

Summary

Pain is the cardinal symptom of acute recurrent and chronic pancreatitis, and available medical treatments have limited efficacy. Pain self-management programs equip patients to minimize the impact of chronic painful conditions on activity, health, and psychosocial functioning. The purpose of the current study is to pilot the use of Internet-delivered pain self-management course in adults with chronic and acute recurrent pancreatitis to generate preliminary feasibility and acceptability data to inform design of a subsequent large randomized controlled trial.

Conditions

  • Pancreatitis, Chronic
  • Pancreatitis, Acute Recurrent

Interventions

BEHAVIORAL

Internet-based CBT intervention

The Internet-delivered Pancreatitis Pain Course consists of 5 lessons: 1) introduction, education, and symptom identification, 2) thought monitoring and challenging, 3) controlled breathing and pleasant activity scheduling, 4) activity pacing, and 5) relapse prevention and goal setting. Participants aim to complete one online lesson weekly for 5 weeks, and have up to 2 months to complete the course. Each lesson has a homework assignment to encourage participants to practice and apply skills. A coach who is part of the Seattle Children's Research Institute study team will make weekly contact with participants in the intervention arm through telephone or secure e-mail, for a period of between 10-15 minutes to encourage participants to work through the Course and apply the skills.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Tonya M Palermo, PhD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03322644 on ClinicalTrials.gov