Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial

Tonya M Palermo, Emily F Law, Mark D Topazian, Katherine Slack, Blake F Dear, Yeon Joo Ko, Santhi Swaroop Vege, Evan Fogel, Guru Trikudanathan, Dana K Andersen, Darwin L Conwell, Dhiraj Yadav, Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC), Tonya M Palermo, Emily F Law, Mark D Topazian, Katherine Slack, Blake F Dear, Yeon Joo Ko, Santhi Swaroop Vege, Evan Fogel, Guru Trikudanathan, Dana K Andersen, Darwin L Conwell, Dhiraj Yadav, Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)

Abstract

Introduction: Severe abdominal pain is a cardinal symptom of chronic pancreatitis (CP) associated with a high economic and societal burden. In other chronic pain conditions, cognitive-behavioral therapy (CBT) has demonstrated efficacy in improving patient outcomes (e.g., pain-related disability and depression). However, CBT has not yet been evaluated in adult patients with painful CP. We aimed to (i) evaluate the feasibility and acceptability of an adapted Internet CBT program for CP and (ii) generate pilot data regarding the effects of treatment on patient pain outcomes.

Methods: Thirty adults (mean age = 49.8 years, SD = 12.5; 80% women) with suspected or definite CP were randomized to Internet CBT (Pancreatitis Pain Course) versus control. The Pancreatitis Pain Course has 5 CBT lessons (e.g., thought challenging, relaxation, and activity pacing) delivered over 8 weeks. Pain interference, pain intensity, and quality of life were assessed at pretreatment, posttreatment, and the 3-month follow-up. Qualitative interviews were conducted at posttreatment with a subset of participants.

Results: Eighty percent of participants rated the program as highly acceptable; 64.3% completed all 5 lessons. Qualitative data revealed positive perceptions of program features, relevancy, and skills. Patients randomized to Internet CBT demonstrated moderate to large effects in reducing pain intensity and pain interference from baseline to 3 months. The proportion of treatment responders (>30% improvement) was significantly greater in the Internet-CBT group than in the control group (50% vs 13%, Fisher exact t test P = 0.04).

Discussion: In this first trial of CBT pain self-management in CP, feasibility, acceptability, and preliminary efficacy for reducing pain and disability were demonstrated. Future definitive trials of CBT are needed.

Trial registration: ClinicalTrials.gov NCT03322644.

Conflict of interest statement

Guarantor of the article: Tonya M. Palermo, PhD.

Specific author contributions: T.M.P. and M.D.T.: conceived and designed the study. M.D.T., S.S.V., E.F., G.T., D.L.C., and D.Y.: reviewed participants for study eligibility. T.M.P. and B.F.D.: adapted the intervention. K.S. and Y.J.K.: performed the qualitative interviews and analysis. E.F.L.: conducted the data analysis. T.M.P. and E.F.L.: drafted the manuscript. B.F.D., D.L.C., D.Y., and D.K.A.: provided critical revisions for important intellectual content. All authors revised the manuscript and approved the final version.

Financial support: Research reported in this publication was supported by the National Cancer Institute and National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award numbers U01 DK108306 (D.Y.), U01 DK108323 (E.F.), U01 DK126300 (G.T.), U01 DK108327 (D.L.C.), and U01 DK108288 (M.D.T., S.S.V., and T.M.P.). E.F.L. was supported by K23NS089966 from the National Institute of Neurologic Disorders and Stroke of the National Institutes of Health. K.S. was supported by a University of Washington Mary Gates Research Scholarship Award. B.F.D. was supported by an Australian NHMRC Career Development Fellowship. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Potential competing interests: T.M.P., E.F.L., M.D.T., K.S., Y.J.K., S.S.V., E.F., G.T., D.K.A., D.L.C., and D.Y. have no conflicts of interest to declare. B.F.D. is a developer of the Pain Course, but derives no personal or financial benefit from it.

Clinical trial registration: ClinicalTrials.gov; Identifier: NCT03322644.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.

Figures

Figure 1.
Figure 1.
CONSORT flowchart.
Figure 2.
Figure 2.
Treatment responders by group. CBT, cognitive-behavioral therapy; WL, waitlist.

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Source: PubMed

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