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

Seattle Children's Hospital32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

Internet-based CBT interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment acceptability

Participants will complete a 12-item Treatment Evaluation Inventory questionnaire that assesses satisfaction and acceptability of the course of treatment and satisfaction with the outcome of the intervention. Items are rated on a 5-point Likert scale ranging from 1 = Strongly disagree, to 5 = Strongly agree.

Time frame: Immediately post-treatment

Secondary Outcomes

Treatment feasibility

Feasibility will be determined by calculating rates of accrual, drop out, compliance, and missing data. Criteria for feasibility success will be based on: accrual rates \>70%, attrition rates \<15%, minimal technical difficulties (i.e., reported by \<10%), adherence rates \>80%, and minimal missing data.

Time frame: Immediately post-treatment

Change in pain intensity

Participants will report on presence and intensity of pain daily for 7 days at each assessment period. Pain intensity will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain, and 10 = worst pain. Mean average intensity of the pain reported will serve as the pain measure.