NCT03322644

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

Development and Feasibility Testing of an Internet-based Pain Self-management Program for Persons With Acute Recurrent and Chronic Pancreatitis Pain (The IMPACT Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) are associated with high disease burden across the lifespan. Recurring abdominal pain is the most prevalent and distressing symptom. Pain severity reduces health-related quality of life for individuals with CP and is associated with increased fatigue, anxiety and depressive symptoms, lower general health status, and reduced physical and role functioning. Medical therapies for CP pain have limited efficacy. Cognitive-behavioral interventions (CBT) offer safe and effective alternatives to pharmacological treatments for pain management. In other chronic painful conditions including gastrointestinal disorders, CBT interventions have been effective for reducing pain and pain impact including disability and depressive symptoms. CBT is traditionally provided by trained psychologists working with individual patients one-on-one or in small groups. Access to CBT is limited by availability of providers, with long waiting lists at centers offering CBT. The Internet is an ideal medium to provide pain self-management interventions that are low-cost and sustainable, and internet-based CBT has shown efficacy in children and adults with chronic pain, allowing clinics to greatly extend their reach to patients. The purpose of this study is to test the acceptability, feasibility, and preliminary efficacy of an Internet-delivered CBT pain self-management course for adults with acute recurrent and chronic pancreatitis pain.

Conditions

• Pancreatitis, Chronic
• Pancreatitis, Acute Recurrent

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2017-10-26
• Last updated: 2021-09-27

Locations

1 site across 1 country: United States