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

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Brief Title

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

Official Title

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

Brief 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.
    


Study Type

Interventional


Primary Outcome

Treatment acceptability

Secondary Outcome

 Treatment feasibility

Condition

Pancreatitis, Chronic

Intervention

Internet-based CBT intervention

Study Arms / Comparison Groups

 Internet-based CBT intervention
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

32

Start Date

February 1, 2018

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tonya M Palermo, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03322644

Organization ID

Mayo IRB #17-007214

Secondary IDs

U01DK108334

Responsible Party

Principal Investigator

Study Sponsor

Seattle Children's Hospital

Collaborators

 Mayo Clinic

Study Sponsor

Tonya M Palermo, PhD, Principal Investigator, Seattle Children's Research Institute


Verification Date

May 2020