Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial.
Journal
Clinical and translational gastroenterology
ISSN: 2155-384X
Titre abrégé: Clin Transl Gastroenterol
Pays: United States
ID NLM: 101532142
Informations de publication
Date de publication:
18 06 2021
18 06 2021
Historique:
received:
18
03
2021
accepted:
12
05
2021
entrez:
18
6
2021
pubmed:
19
6
2021
medline:
27
1
2022
Statut:
epublish
Résumé
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. 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. 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). 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.
Identifiants
pubmed: 34140460
doi: 10.14309/ctg.0000000000000373
pii: 01720094-202106000-00010
pmc: PMC8216675
doi:
Banques de données
ClinicalTrials.gov
['NCT03322644']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e00373Subventions
Organisme : NIDDK NIH HHS
ID : U01 DK108327
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK108323
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK108288
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK126300
Pays : United States
Organisme : NINDS NIH HHS
ID : K23 NS089966
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK108306
Pays : United States
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.
Références
Amann ST, Yadav D, Barmada MM, et al. Physical and mental quality of life in chronic pancreatitis: A case-control study from the North American Pancreatitis Study 2 cohort. Pancreas 2013;42(2):293–300.
Cote GA, Yadav D, Abberbock JA, et al. Recurrent acute pancreatitis significantly reduces quality of life even in the absence of overt chronic pancreatitis. Am J Gastroenterol 2018;113(6):906–12.
Peery AF, Crockett SD, Murphy CC, et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology 2019;156(1):254–72 e211.
Wilcox CM, Yadav D, Ye T, et al. Chronic pancreatitis pain pattern and severity are independent of abdominal imaging findings. Clin Gastroenterol Hepatol 2015;13(3):552–60; quiz e28–9.
Mullady DK, Yadav D, Amann ST, et al. Type of pain, pain-associated complications, quality of life, disability and resource utilisation in chronic pancreatitis: A prospective cohort study. Gut 2011;60(1):77–84.
Olesen SS, Nojgaard C, Novovic S, et al. Pain and aetiological risk factors determine quality of life in patients with chronic pancreatitis, but a brick in the puzzle is missing. Pancreatology 2020;20(7):1347–53.
Nusrat S, Yadav D, Bielefeldt K. Pain and opioid use in chronic pancreatitis. Pancreas 2012;41(2):264–70.
Drewes AM, Bouwense SAW, Campbell CM, et al.; Working group for the International Consensus Guidelines for Chronic Pancreatitis. Guidelines for the understanding and management of pain in chronic pancreatitis. Pancreatology 2017;17(5):720–31.
Williams AC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2012;11:CD007407.
Aivaliotis VI, Lee Y, Zia J, et al. Telephone-based mindfulness therapy intervention for patients with chronic pancreatitis. Dig Dis Sci 2017;62(2):502–9.
Becker WC, Dorflinger L, Edmond SN, et al. Barriers and facilitators to use of non-pharmacological treatments in chronic pain. BMC Fam Pract 2017;18(1):41.
Giannitrapani K, McCaa M, Haverfield M, et al. Veteran experiences seeking non-pharmacologic approaches for pain. Mil Med 2018;183(11–12):e628–34.
Palermo TM, Jamison RN. Innovative delivery of pain management interventions: Current trends and future progress. Clin J Pain 2015;31(6):467–9.
Dear BF, Gandy M, Karin E, et al. The pain course: A randomised controlled trial comparing a remote-delivered chronic pain management program when provided in online and workbook formats. Pain 2017;158(7):1289–301.
Dear BF, Gandy M, Karin E, et al. The Pain CSourse: A randomised controlled trial examining an internet-delivered pain management program when provided with different levels of clinician support. Pain 2015;156(10):1920–35.
Yadav D, Park WG, Fogel EL, et al.; Consortium for the Study of Chronic Pancreatitis Diabetes, and Pancreatic Cancer (CPDPC). PROspective Evaluation of Chronic Pancreatitis for EpidEmiologic and Translational StuDies: Rationale and study design for PROCEED from the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer. Pancreas 2018;47(10):1229–38.
Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)—A metdata-drive methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81.
Pilkonis PA, Yu L, Colditz J, et al. Item banks for alcohol use from the Patient-Reported Outcomes Measurement Information System (PROMIS): Use, consequences, and expectancies. Drug Alcohol Depend 2013;130(1–3):167–77.
Kroenke K, Yu Z, Wu J, et al. Operating characteristics of PROMIS four-item depression and anxiety scales in primary care patients with chronic pain. Pain Med 2014;15(11):1892–901.
Kelley ML, Heffer R, Gresham F, et al. Development of a modified treatment evaluation inventory. J Psychopathol Behav Assess 1989;11(3):235–47.
Cleeland CS, Ryan KM. Pain assessment: Global use of the brief pain inventory. Ann Acad Med Singapore 1994;23(2):129–38.
Tan G, Jensen MP, Thornby JI, et al. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain 2004;5(2):133–7.
Wassef W, DeWitt J, McGreevy K, et al. Pancreatitis quality of life instrument: A psychometric evaluation. Am J Gastroenterol 2016;111(8):1177–86.
Whitehead AL, Julious SA, Cooper CL, et al. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res 2016;25(3):1057–73.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3(2):77–101.
Cohen J. Statistical Power Analysis for the Behavioral Sciences. Lawrence Erlbaum Associates: Hillsdale, NJ, 1988.
Patel KV, Allen R, Burke L, et al. Evaluation of composite responder outcomes of pain intensity and physical function in neuropathic pain clinical trials: An ACTTION individual patient data analysis. Pain 2018;159(11):2245–54.
Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9(2):105–21.
Dear BF, Gandy M, Karin E, et al. The pain course: 12- and 24-month outcomes from a randomized controlled trial of an internet-delivered pain management program provided with different levels of clinician support. J Pain 2018;19(12):1491–503.
Gurusamy KS, Lusuku C, Davidson BR. Pregabalin for decreasing pancreatic pain in chronic pancreatitis. Cochrane Database Syst Rev 2016;2:CD011522.
Issa Y, Kempeneers MA, Bruno MJ, et al.; Dutch Pancreatitis Study Group. Effect of early surgery vs endoscopy-first approach on pain in patients with chronic pancreatitis: The ESCAPE randomized clinical trial. JAMA 2020;323(3):237–47.
Siegel CA. Transforming gastroenterology care with telemedicine. Gastroenterology 2017;152(5):958–63.
Eccleston C, Blyth FM, Dear BF, et al. Managing patients with chronic pain during the COVID-19 outbreak: Considerations for the rapid introduction of remotely supported (eHealth) pain management services. Pain 2020;161(5):889–93.
Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005;113(1–2):9–19.
Nielssen O, Karin E, Staples L, et al. Opioid use before and after completion of an online pain management program. J Consult Clin Psychol 2019;87(10):904–17.