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

Seattle Children's Healthcare System

Status: Completed

Conditions: Pancreatitis, Acute Recurrent; Pancreatitis, Chronic

Treatments: Behavioral: Internet-based CBT intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03322644

Mayo IRB #17-007214

U01DK108334 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Able and willing to provide informed consent for participation in this study
3. Meet CPDPC criteria for diagnosis of either suspected CP (CPDPC "yellow zone") or definite CP (CPDPC "red zone")
4. Have personal internet access on any device (e.g., phone, tablet, computer)
5. Has experienced pain intensity rated as 4 or higher on a 0-10 scale in the last month

Exclusion criteria

1. Currently undergoing treatment for cancer
2. Inability to understand English well enough to complete questionnaires or to participate in treatment
3. Severe depression (i.e., indicated by a score > 22 on the Patient Health Questionnaire (PHQ-9)
4. Significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 of the PHQ-9)
5. Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months)
6. Currently receiving treatment with a psychologist

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Internet-based CBT intervention

Experimental group

Description:

In addition to standard medical care, participants in the Internet-based CBT group will receive access to the Pancreatitis Pain Course and will be asked to complete all online modules over 2 months using their own smartphone or computer. A coach will guide participants through the weekly lessons.

Treatment:

Behavioral: Internet-based CBT intervention

Wait list control group

No Intervention group

Description:

Participants assigned to the Wait list control group will be asked to continue with any recommendations made by their clinic provider and will not be offered any internet-based content until after they complete the 5 month assessments (i.e. Months 5-7).