Randomised clinical trial: Psychological intervention improves work productivity and daily activity by reducing abdominal pain and fatigue in Crohn's disease.
abdominal pain
disability
fatigue
inflammatory bowel disease
mediation analysis
randomised controlled trial
Journal
Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234
Informations de publication
Date de publication:
04 2023
04 2023
Historique:
revised:
13
08
2022
received:
15
07
2022
accepted:
12
01
2023
pubmed:
4
2
2023
medline:
28
3
2023
entrez:
3
2
2023
Statut:
ppublish
Résumé
Chronic abdominal pain and fatigue are characteristics of Crohn's disease (CD) and contribute to functional impairments. To examine whether CD-tailored cognitive-behavioural and mindfulness intervention (COBMINDEX) is effective in reducing abdominal pain and fatigue in patients with CD and whether changes in abdominal pain and fatigue mediate any beneficial effects of COBMINDEX on impairments in work productivity and daily activities. This is a secondary analysis of a parallel-group multicentre randomised controlled trial. Patients with mild-to-moderate CD (n = 142) were randomised into either intervention group receiving COBMINDEX, or control group receiving treatment-as-usual for 3 months followed by COBMINDEX. Complete data were collected from 120 patients (34.0 ± 10.7 years, 62.5% female, intervention = 60, control = 60). Analysis of covariance assessed group differences in 3-month follow-up scores, controlling for baseline scores. Multiple parallel mediation analysis assessed the proposed mechanisms for the entire sample. The intervention group demonstrated significantly lower levels of abdominal pain (F = 17.46, p < 0.001, η COBMINDEX is effective at reducing abdominal pain and fatigue in patients with CD, which in turn leads to improvement in functioning. Clinicians should incorporate screening for severe abdominal pain and fatigue and consider offering cognitive-behavioural and mindfulness training. gov, Number: NCT05085925. Ministry of Health in Israel (https://my.health.gov.il/CliniTrials/Pages/MOH_2020-02-24_008721.aspx).
Sections du résumé
BACKGROUND
Chronic abdominal pain and fatigue are characteristics of Crohn's disease (CD) and contribute to functional impairments.
AIMS
To examine whether CD-tailored cognitive-behavioural and mindfulness intervention (COBMINDEX) is effective in reducing abdominal pain and fatigue in patients with CD and whether changes in abdominal pain and fatigue mediate any beneficial effects of COBMINDEX on impairments in work productivity and daily activities.
METHODS
This is a secondary analysis of a parallel-group multicentre randomised controlled trial. Patients with mild-to-moderate CD (n = 142) were randomised into either intervention group receiving COBMINDEX, or control group receiving treatment-as-usual for 3 months followed by COBMINDEX. Complete data were collected from 120 patients (34.0 ± 10.7 years, 62.5% female, intervention = 60, control = 60). Analysis of covariance assessed group differences in 3-month follow-up scores, controlling for baseline scores. Multiple parallel mediation analysis assessed the proposed mechanisms for the entire sample.
RESULTS
The intervention group demonstrated significantly lower levels of abdominal pain (F = 17.46, p < 0.001, η
CONCLUSIONS
COBMINDEX is effective at reducing abdominal pain and fatigue in patients with CD, which in turn leads to improvement in functioning. Clinicians should incorporate screening for severe abdominal pain and fatigue and consider offering cognitive-behavioural and mindfulness training.
CLINICALTRIALS
gov, Number: NCT05085925. Ministry of Health in Israel (https://my.health.gov.il/CliniTrials/Pages/MOH_2020-02-24_008721.aspx).
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
861-871Informations de copyright
© 2023 John Wiley & Sons Ltd.
Références
Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017;389(10080):1741-55. https://doi.org/10.1016/S0140-6736(16)31711-1
Czuber-Dochan W, Ream E, Norton C. Review article: description and management of fatigue in inflammatory bowel disease. Aliment Pharmacol Ther. 2013;37(5):505-16. https://doi.org/10.1111/apt.12205
Cohen BL, Zoëga H, Shah SA, LeLeiko N, Lidofsky S, Bright R, et al. Fatigue is highly associated with poor health-related quality of life, disability and depression in newly-diagnosed patients with inflammatory bowel disease, independent of disease activity. Aliment Pharmacol Ther. 2014;39(8):811-22. https://doi.org/10.1111/apt.12659
van Langenberg DR, Papandony MC, Gibson PR. Sleep and physical activity measured by accelerometry in Crohn's disease. Aliment Pharmacol Ther. 2015;41(10):991-1004. https://doi.org/10.1111/apt.13160
Schreiner P, Rossel JB, Biedermann L, Valko PO, Baumann CR, Greuter T, et al. Fatigue in inflammatory bowel disease and its impact on daily activities. Aliment Pharmacol Ther. 2021;53(1):138-49. https://doi.org/10.1111/apt.16145
D'Silva A, Fox DE, Nasser Y, Vallance JK, Quinn RR, Ronksley PE, et al. Prevalence and risk factors for fatigue in adults with inflammatory bowel disease: a systematic review with meta-analysis. Clin Gastroenterol Hepatol. 2022;20(5):995-1009.e7. https://doi.org/10.1016/j.cgh.2021.06.034
Casati J, Toner BB, de Rooy EC, Drossman DA, Maunder RG. Concerns of patients with inflammatory bowel disease: a review of emerging themes. Dig Dis Sci. 2000;45(1):26-31. https://doi.org/10.1023/A:1005492806777
Borren NZ, van der Woude CJ, Ananthakrishnan AN. Fatigue in IBD: epidemiology, pathophysiology and management. Nat Rev Gastroenterol Hepatol. 2019;16:247-59. https://doi.org/10.1038/s41575-018-0091-9
Zeitz J, Ak M, Muller-Mottet S, Scharl S, Biedermann L, Fournier N, et al. Pain in IBD patients: very frequent and frequently insufficiently taken into account. PLoS One. 2016;11(6):e0156666. https://doi.org/10.1371/journal.pone.0156666
Bielefeldt K, Davis B, Binion DG. Pain and inflammatory bowel disease. Inflamm Bowel Dis. 2009;15(5):778-88. https://doi.org/10.1002/ibd.20848
Dulai PS, Jairath V, Khanna R, Ma C, McCarrier KP, Martin ML, et al. Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis. Aliment Pharmacol Ther. 2020;51(11):1047-66. https://doi.org/10.1111/apt.15726
Odes S, Friger M, Sergienko R, Schwartz D, Sarid O, Slonim-Nevo V, et al. Simple pain measures reveal psycho-social pathology in patients with Crohn's disease. World J Gastroenterol. 2017;23(6):1076-89. https://doi.org/10.3748/wjg.v23.i6.1076
Coates MD, Seth N, Clarke K, Abdul-Baki H, Mahoney N, Walter V, et al. Opioid analgesics do not improve abdominal pain or quality of life in Crohn's disease. Dig Dis Sci. 2020;65(8):2379-87. https://doi.org/10.1007/s10620-019-05968-x
Sweeney L, Moss-Morris R, Czuber-Dochan W, Meade L, Chumbley G, Norton C. Systematic review: psychosocial factors associated with pain in inflammatory bowel disease. Aliment Pharmacol Ther. 2018;47(6):715-29. https://doi.org/10.1111/apt.14493
Dalal RS, Palchaudhuri S, Snider CK, Lewis JD, Mehta SJ, Lichtenstein GR. Exposure to intravenous opioids is associated with future exposure to opioids in hospitalized patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2020;18(10):2269-2278.e3. https://doi.org/10.1016/j.cgh.2019.12.024
Lichtenstein GR, Feagan BG, Cohen RD, Salzberg BA, Diamond RH, Price S, et al. Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT registry. Am J Gastroenterol. 2012;107(9):1409-22. https://doi.org/10.1038/ajg.2012.218
Burr NE, Smith C, West R, Hull MA, Subramanian V. Increasing prescription of opiates and mortality in patients with inflammatory bowel diseases in England. Clin Gastroenterol Hepatol. 2018;16(4):534-541.e6. https://doi.org/10.1016/j.cgh.2017.10.022
le Berre C, Ananthakrishnan AN, Danese S, Singh S, Peyrin-Biroulet L. Ulcerative colitis and Crohn's disease have similar burden and goals for treatment. Clin Gastroenterol Hepatol. 2020;18(1):14-23. https://doi.org/10.1016/j.cgh.2019.07.005
Williet N, Sarter H, Gower-Rousseau C, Adrianjafy C, Olympie A, Buisson A, et al. Patient-reported outcomes in a French Nationwide survey of inflammatory bowel disease patients. J Crohns Colitis. 2017;11(2):165-74. https://doi.org/10.1093/ecco-jcc/jjw145
Khalili H, Everhov ÅH, Halfvarson J, Ludvigsson JF, Askling J, Myrelid P, et al. Healthcare use, work loss and total costs in incident and prevalent Crohn's disease and ulcerative colitis: results from a nationwide study in Sweden. Aliment Pharmacol Ther. 2020;52(4):655-68. https://doi.org/10.1111/apt.15889
Osadchiy V, Martin CR, Mayer EA. The gut-brain Axis and the microbiome: mechanisms and clinical implications. Clin Gastroenterol Hepatol. 2019;17(2):322-32. https://doi.org/10.1016/j.cgh.2018.10.002
Labanski A, Langhorst J, Engler H, Elsenbruch S. Stress and the brain-gut axis in functional and chronic-inflammatory gastrointestinal diseases: a transdisciplinary challenge. Psychoneuroendocrinology. 2020;111:104501. https://doi.org/10.1016/j.psyneuen.2019.104501
Nemirovsky A, Ilan K, Lerner L, Cohen-Lavi L, Schwartz D, Goren G, et al. Brain-immune axis regulation is responsive to cognitive behavioral therapy and mindfulness intervention: observations from a randomized controlled trial in patients with Crohn's disease. Brain Behav Immun Health. 2022;19:100407. https://doi.org/10.1016/j.bbih.2021.100407
Sajadinejad MS, Asgari K, Molavi H, Kalantari M, Adibi P. Psychological issues in inflammatory bowel disease: an overview. Gastroenterol Res Pract. 2012;2012:106502. https://doi.org/10.1155/2012/106502
Goren G, Schwartz D, Friger M, Banai H, Sergienko R, Regev S, et al. Randomized controlled trial of cognitive-behavioral and mindfulness-based stress reduction on the quality of life of patients with Crohn disease. Inflamm Bowel Dis. 2022;28(3):393-408. https://doi.org/10.1093/ibd/izab083
Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980;315(8167):514. https://doi.org/10.1016/S0140-6736(80)92767-1
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4(5):353-65. https://doi.org/10.2165/00019053-199304050-00006
Tinsley A, MacKlin EA, Korzenik JR, Sands BE. Validation of the functional assessment of chronic illness therapy-fatigue (FACIT-F) in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011;34(11-12):1328-36. https://doi.org/10.1111/j.1365-2036.2011.04871.x
Irvine EJ, Zhou Q, Thompson AK. The short inflammatory bowel disease questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT investigators. Canadian Crohn's relapse prevention trial. Am J Gastroenterol. 1996;91(8):1571-8.
Ware JE, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220-33.
Mujagic Z, Keszthelyi D, Aziz Q, Reinisch W, Quetglas EG, de Leonardis F, et al. Systematic review: instruments to assess abdominal pain in irritable bowel syndrome. Aliment Pharmacol Ther. 2015;42(9):1064-81. https://doi.org/10.1111/apt.13378
Spiegel B, Bolus R, Harris LA, Lucak S, Naliboff B, Esrailian E, et al. Measuring irritable bowel syndrome patient-reported outcomes with an abdominal pain numeric rating scale. Aliment Pharmacol Ther. 2009;30(11-12):1159-70. https://doi.org/10.1111/j.1365-2036.2009.04144.x
Regev S, Odes S, Slonim-Nevo V, Friger M, Schwartz D, Sergienko R, et al. Differential relationships of somatization, depression, and anxiety to severity of Crohn's disease. J Health Psychol. 2021;26(13):2390-401. https://doi.org/10.1177/1359105320909879
Regev S, Odes S, Slonim-Nevo V, Goren G, Friger M, Greenberg D, et al. Normative data for the brief symptom inventory for patients with Crohn's disease. Psychol Health. 2022;37(2):246-57. https://doi.org/10.1080/08870446.2020.1862841
Derogatis LR. The brief symptom inventory: an introductory report. Psychol Med. 1983;13(3):595-605. https://doi.org/10.1017/S0033291700048017
Montoya AK, Hayes AF. Two-condition within-participant statistical mediation analysis: a path-analytic framework. Psychol Methods. 2017;22(1):6-27. https://doi.org/10.1037/met0000086
Templeton GF. A two-step approach for transforming continuous variables to normal: implications and recommendations for IS research. Commun Assoc Inform Syst. 2011;28(1):41-58. https://doi.org/10.17705/1cais.02804
Spiegel BMR, Bolus R, Harris LA, Lucak S, Chey WD, Sayuk G, et al. Characterizing abdominal pain in IBS: guidance for study inclusion criteria, outcome measurement and clinical practice. Aliment Pharmacol Ther. 2010;32(9):1192-202. https://doi.org/10.1111/j.1365-2036.2010.04443.x
Artom M, Czuber-Dochan W, Sturt J, Murrells T, Norton C. The contribution of clinical and psychosocial factors to fatigue in 182 patients with inflammatory bowel disease: a cross-sectional study. Aliment Pharmacol Ther. 2017;45(3):403-16. https://doi.org/10.1111/apt.13870
McGing JJ, Radford SJ, Francis ST, Serres S, Greenhaff PL, Moran GW. Review article: the aetiology of fatigue in inflammatory bowel disease and potential therapeutic management strategies. Aliment Pharmacol Ther. 2021;54(4):368-87. https://doi.org/10.1111/apt.16465
Norton C, Czuber-Dochan W, Artom M, Sweeney L, Hart A. Systematic review: interventions for abdominal pain management in inflammatory bowel disease. Aliment Pharmacol Ther. 2017;46(2):115-25. https://doi.org/10.1111/apt.14108