Mindfulness-based cognitive therapy for inflammatory bowel disease patients: Findings from an exploratory pilot randomised controlled trial

Trials

Volumn 16, Issue 1, 2015, Pages

  Schoultz, Mariyana ^a   Atherton, Iain ^b   Watson, Angus ^c  

^a UNIVERSITY OF STIRLING   (United Kingdom)

^b EDINBURGH NAPIER UNIVERSITY   (United Kingdom)

^c RAIGMORE HOSPITAL   (United Kingdom)

Author keywords

indfulness based cognitive therapyMBCTInflammatory bowel diseaseCrohn's diseaseUlcerative colitisDepressionAnxietyQuality of lifePilot randomised controlled tria

Indexed keywords

ANTIDEPRESSANT AGENT;

ADULT; ANXIETY; ARTICLE; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL PROTOCOL; COGNITIVE THERAPY; CONTROLLED STUDY; DEPRESSION; DISEASE ACTIVITY; FEMALE; FOLLOW UP; HUMAN; INFLAMMATORY BOWEL DISEASE; MALE; METHODOLOGY; MINDFULNESS; MULTICENTER STUDY; OUTCOME ASSESSMENT; OUTPATIENT DEPARTMENT; PHASE 1 CLINICAL TRIAL; PILOT STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; SCORING SYSTEM; UNSPECIFIED SIDE EFFECT; CLINICAL TRIAL; COLITIS, ULCERATIVE; CROHN DISEASE; FEASIBILITY STUDY; MIDDLE AGED; NATIONAL HEALTH SERVICE; PATIENT DROPOUT; PATIENT SELECTION; PSYCHOLOGICAL RATING SCALE; PSYCHOLOGY; QUESTIONNAIRE; RECURRENT DISEASE; SCOTLAND; TIME FACTOR; TREATMENT OUTCOME;

ADULT; ANXIETY; COLITIS, ULCERATIVE; CROHN DISEASE; DEPRESSION; FEASIBILITY STUDIES; FEMALE; HUMANS; MALE; MIDDLE AGED; MINDFULNESS; PATIENT DROPOUTS; PATIENT SELECTION; PILOT PROJECTS; PSYCHIATRIC STATUS RATING SCALES; QUALITY OF LIFE; RECURRENCE; SAMPLE SIZE; SCOTLAND; STATE MEDICINE; SURVEYS AND QUESTIONNAIRES; TIME FACTORS; TREATMENT OUTCOME;

EID: 84939793916     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0909-5     Document Type: Article

References (83)

1. Baumgart DC, Sandborn WJ. Crohn's disease. Lancet. 2012;380(9853):1590-605.
2. Carter MJ, Lobo AJ, Travis SP, IBD Section, British Society of Gastroenterology. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2004;53 Suppl 5:V1-16.
3. Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006;55:749-53.
4. Mittermaier C, Dejaco C, Waldhoer T, Oefferlbauer-Ernst A, Miehsler W, Beier M, et al. Impact of depressive mood on relapse in patients with inflammatory bowel disease: a prospective 18-month follow-up study. Psychosom Med. 2004;66:79-84.
5. Graff LA, Walker JR, Bernstein CN. Depression and anxiety in inflammatory bowel disease: a review of comorbidity and management. Inflamm Bowel Dis. 2009;15:1105-18.
6. Faust AH, Halpern LF, Danoff-Burg S, Cross RK. Psychosocial factors contributing to inflammatory bowel disease activity and health-related quality of life. Gastroenterol Hepatol. 2012;8:173.
7. Levenstein S. Embracing complexity: what determines quality of life in inflammatory bowel disease? Eur J Gastroenterol Hepatol. 2004;16:1253-5.
8. Simrén M, Axelsson J, Gillberg R, Abrahamsson H, Svedlund J, Björnsson ES. Quality of life in inflammatory bowel disease in remission: the impact of IBS-like symptoms and associated psychological factors. Am J Gastroenterol. 2002;97:389-96.
9. Keighly MRBSR. Inflammatory bowel disease. Aliment Pharm Ther. 2003;18 suppl 3:66-70.
10. Mikocka-Walus AA, Turnbull DA, Moulding NT, Wilson IG, Andrews JM, Holtmann GJ. Antidepressants and inflammatory bowel disease: a systematic review. Clin Pract Epidemiol Ment Health. 2006;2:24.
11. Mikocka-Walus AA, Turnbull DA, Moulding NT, Wilson IG, Andrews JM, Holtmann GJ. It doesn't do any harm, but patients feel better": a qualitative exploratory study on gastroenterologists' perspectives on the role of antidepressants in inflammatory bowel disease. BMC Gastroenterol. 2007;7:38.
12. Goodhand J, Greig F, Koodun Y, McDermott A, Wahed M, Langmead L, et al. Do antidepressants influence the disease course in inflammatory bowel disease? A retrospective case matched observational study. Inflamm Bowel Dis. 2012;18:1232-9.
13. Bernal I, Domènech E, Garcia-Planella E, Marín L, Mañosa M, Navarro M, et al. Medication-taking behavior in a cohort of patients with inflammatory bowel disease. Dig Dis Sci. 2006;51:2165-9.
14. Jackson C, Clatworthy J, Robinson A, Horne R. Factors associated with non-adherence to oral medication for inflammatory bowel disease: a systematic review. Am J Gastroenterol. 2010;105:525-39.
15. Pacher P, Kecskemeti V. Cardiovascular side effects of new antidepressants and antipsychotics: new drugs, old concerns? Curr Pharm Des. 2004;10:2463-75.
16. Andersohn F, Schade R, Suissa S, Garbe E. Long-term use of antidepressants for depressive disorders and the risk of diabetes mellitus. Am J Psychiatry. 2009;166:591-8.
17. Makins R, Ballinger A. Gastrointestinal side effects of drugs. Expert Opin Drug Saf. 2003;2:421-9.
18. Goodhand JR, Wahed M, Rampton DS. Management of stress in inflammatory bowel disease: a therapeutic option? Expert Rev Gastroenterol Hepatol. 2009;3:661-79.
19. von Wietersheim J, Kessler H. Psychotherapy with chronic inflammatory bowel disease patients: a review. Inflamm Bowel Dis. 2006;12:1175-84.
20. McCombie AM, Mulder RT, Gearry RB. Psychotherapy for inflammatory bowel disease: a review and update. J Croat Stud. 2013;7:935-49.
21. Knowles SR, Monshat K, Castle DJ. The efficacy and methodological challenges of psychotherapy for adults with inflammatory bowel disease: a review. Inflamm Bowel Dis. 2013;19:2704-15.
22. Segal ZV, Teasdale JD, Williams J, Gemar MC. The mindfulness-based cognitive therapy adherence scale: Inter- rater reliability, adherence to protocol and treatment distinctiveness. Clin Psychol Psychother. 2002;9:131-8.
23. Segal ZV, Williams JMG, Teasdale JD. Mindfulness-based cognitive therapy for depression. New York: Guilford Publication; 2012
24. Baer RA. Mindfulness training as a clinical intervention: A conceptual and empirical review. Clin Psychol Sci Pract. 2003;10:125-43.
25. Merkes M. Mindfulness-based stress reduction for people with chronic diseases. Aust J Prim Health. 2010;16:200-10.
26. Rosenzweig S, Greeson JM, Reibel DK, Green JS, Jasser SA, Beasley D. Mindfulness-based stress reduction for chronic pain conditions: variation in treatment outcomes and role of home meditation practice. J Psychosom Res. 2010;68:29-36.
27. Bohlmeijer E, Prenger R, Taal E, Cuijpers P. The effects of mindfulness-based stress reduction therapy on mental health of adults with a chronic medical disease: a meta-analysis. J Psychosom Res. 2010;68:539-44.
28. Sadlier M, Stephens S, Kennedy V. Tinnitus rehabilitation: a mindfulness meditation cognitive behavioural therapy approach. J Laryngol Otol. 2008;122:31-7.
29. Shigaki CL, Glass B, Schopp LH. Mindfulness-based stress reduction in medical settings. J Clin Psychol Med Settings. 2006;13:209-16.
30. Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003;65:571-81.
31. Chiesa A, Serretti A. Mindfulness-based interventions for chronic pain: a systematic review of the evidence. J Altern Complement Med. 2011;17:83-93.
32. Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010;78:169.
33. National Institute for CE. Depression: the treatment and management of depression in adults (update). Leicester: British Psychological Society; 2010.
34. Berrill JW, Sadlier M, Hood K, Green JT. Mindfulness-based therapy for inflammatory bowel disease patients with functional abdominal symptoms or high perceived stress levels. J Crohn's Colitis. 2014;8:945-55.
35. Jedel S, Merriman P, Hoffman A, Swanson B, Fogg LF, Keshavarzian A. Relationship of mindfulness, quality of life, and psychiatric symptoms among patients with ulcerative colitis. Mindfulness. 2013;4:296-300.
36. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.
37. Schoultz M, Atherton IM, Hubbard G, Watson AJ. The use of mindfulness-based cognitive therapy for improving quality of life for inflammatory bowel disease patients: study protocol for a pilot randomised controlled trial with embedded process evaluation. Trials. 2013;14:431. doi:10.1186/1745-6215-14-431.
38. Gooberman-Hill R, Burston A, Clark E, Johnson E, Nolan S, Wells V, et al. Involving Patients in Research: Considering Good Practice. Musculoskelet Care. 2013;11:187-90.
39. Pannucci CJ, Wilkins EG. Identifying and avoiding bias in research. Plast Reconstr Surg. 2010;126:619-25.
40. Williams M, Penman D. Mindfulness: An eight-week plan for finding peace in a frantic world: Rodale. 2011.
41. UK Network for Mindfulness-Based Teacher Training. 2011. http://mindfulnessteachersuk.org.uk/pdf/teacher-guidelines.pdf. (Accessed 22 August 2015)
42. Crohns and Colitis UK. Information Sheet. Staying well with IBD. NACC. 2012. http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Info-Sheets/Staying-Well-with-IBD.pdf. (Accessed 22 August 2015)
43. Armijo-Olivo S, Warren S, Magee D. Intention to treat analysis, compliance, drop-outs and how to deal with missing data in clinical research: a review. Phys Ther Rev. 2009;14:36-49.
44. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1. doi:10.1186/1471-2288-10-1.
45. Cook DJ, Rocker G, Meade M, Guyatt G, Geerts W, Anderson D, et al. Prophylaxis of Thromboembolism in Critical Care (PROTECT) Trial: a pilot study. J Crit Care. 2005;20:364-72.
46. Choi PT, Beattie WS, Bryson GL, Paul JE, Yang H. Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study. PloS One. 2009;4:e4644.
47. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18-7015-8-18.
48. Burgess D, Gebski V, Keech A. EBM: trials on trial. Med J Aust. 2003;179:105-7.
49. Beck AT, Steer RA, Ball R, Ranieri WF. Comparison of Beck Depression Inventories-IA and-II in psychiatric outpatients. J Pers Assess. 1996;67:588-97.
50. Beck AT, Steer RA, Carbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clin Psychol Rev. 1988;8:77-100.
51. Akbar A, Yiangou Y, Facer P, Brydon WG, Walters JR, Anand P, et al. Expression of the TRPV1 receptor differs in quiescent inflammatory bowel disease with or without abdominal pain. Gut. 2010;59:767-74.
52. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto: Consulting Psychologists Press; 1983.
53. Carlson LE, Brown KW. Validation of the Mindful Attention Awareness Scale in a cancer population. J Psychosom Res. 2005;58:29-33.
54. MacKillop J, Anderson EJ. Further psychometric validation of the mindful attention awareness scale (MAAS). J Psychopathol Behav Assess. 2007;29:289-93.
55. Goebell H, Wienbeck M, Schomerus H, Malchow H. Evaluation of the Crohn's Disease Activity Index (CDAI) and the Dutch Index for severity and activity of Crohn's disease. An analysis of the data from the European Cooperative Crohn's Disease Study. Med Klin (Munich). 1990;85:573-6.
56. Sipponen T, Savilahti E, Kolho K, Nuutinen H, Turunen U, Färkkilä M. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis. 2008;14:40-6.
57. Best WR, Becktel JM, Singleton JW, Kern F. Development of a Crohn's disease activity index. Gastroenterology. 1976;70:439-44.
58. Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology. 1979;77(4 Pt 2):843-6.
59. Satsangi J. Inflammatory bowel diseases. ed. Jack Satsangi, Lloyd R. Sutherland. Edinburgh: Churchill Livingstone; 2003.
60. Higgins PD, Schwartz M, Mapili J, Krokos I, Leung J, Zimmermann EM. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut. 2005;54:782-8.
61. Guyatt G, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989;96:804-10.
62. Lix LM, Graff LA, Walker JR, Clara I, Rawsthorne P, Rogala L, et al. Longitudinal study of quality of life and psychological functioning for active, fluctuating, and inactive disease patterns in inflammatory bowel disease. Inflamm Bowel Dis. 2008;14:1575-84.
63. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. Proceedings of the Celebrating Health Research: The Annual R & D Conference. Manchester: North West Regional Health Authority; 2002.
64. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10:307-12.
65. Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001;323:1123-4.
66. Brouwer D, Meijer RR, Zevalkink J. Measuring individual significant change on the Beck Depression Inventory-II through IRT-based statistics. Psychother Res. 2013;23:489-501.
67. Bower P, Brueton V, Gamble C, Treweek S, Smith CT, Young B, et al. Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. Trials. 2014;15:399-6215-15-399.
68. McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.
69. Ljótsson B, Falk L, Vesterlund AW, Hedman E, Lindfors P, Rück C, et al. Internet-delivered exposure and mindfulness based therapy for irritable bowel syndrome-a randomized controlled trial. Behav Res Ther. 2010;48:531-9.
70. Kearney DJ, McDermott K, Malte C, Martinez M, Simpson TL. Association of participation in a mindfulness program with measures of PTSD, depression and quality of life in a veteran sample. J Clin Psychol. 2012;68:101-16.
71. Gaylord SA, Palsson OS, Garland EL, Faurot KR, Coble RS, Mann JD, et al. Mindfulness training reduces the severity of irritable bowel syndrome in women: results of a randomized controlled trial. Am J Gastroenterol. 2011;106:1678-88.
72. Miehsler W, Weichselberger M, Öfferlbauer Ernst A, Dejaco C, Reinisch W, Vogelsang H, et al. Which patients with IBD need psychological interventions? A controlled study. Inflamm Bowel Dis. 2008;14:1273-80.
73. Timmer A, Preiss JC, Motschall E, Rücker G, Jantschek G, Moser G. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Libr. 2011;2:CD006913. doi:10.1002/14651858.CD006913.pub2.
74. Bentley CL, Mountain GA, Thompson J, Fitzsimmons DA, Lowrie K, Parker SG, et al. A pilot randomised controlled trial of a Telehealth intervention in patients with chronic obstructive pulmonary disease: challenges of clinician-led data collection. Trials. 2014;15:313. doi:10.1186/1745-6215-15-313.
75. Bird L, Arthur A, Cox K. Did the trial kill the intervention?" experiences from the development, implementation and evaluation of a complex intervention. BMC Med Res Methodol. 2011;11:24.
76. Roos J, Werbart A. Therapist and relationship factors influencing dropout from individual psychotherapy: A literature review. Psychother Res. 2013;23:394-418.
77. Sajadinejad M, Asgari K, Molavi H, Kalantari M, Adibi P. Psychological issues in inflammatory bowel disease: an overview. Gastroenterol Res Pract. 2012;2012:106502. doi:10.1155/2012/106502.
78. Robertson DA, Ray J, Diamond I, Edwards JG. Personality profile and affective state of patients with inflammatory bowel disease. Gut. 1989;30:623-6.
79. Prasko J, Jelenova D, Mihal V. Psychological aspects and psychotherapy of inflammatory bowel diseases and irritable bowel syndrome in children. Biomedical Papers. 2010;154:307-14.
80. Moreno-Jiménez B, Blanco BL, Rodríguez-Muñoz A, Hernández EG. The influence of personality factors on health-related quality of life of patients with inflammatory bowel disease. J Psychosom Res. 2007;62:39-46.
81. Boye B, Lundin KE, Leganger S, Mokleby K, Jantschek G, Jantschek I, et al. The INSPIRE study: do personality traits predict general quality of life (short form-36) in distressed patients with ulcerative colitis and Crohn's disease? Scand J Gastroenterol. 2008;43:1505-13.
82. Bishop S, Forster S. Trait anxiety, neuroticism and the brain basis of vulnerability to affective disorder. In: The Cambridge handbook of human affective neuroscience. Cambridge University Press; 2013. p. 553-74.
83. Barnhofer T, Duggan DS, Griffith JW. Dispositional mindfulness moderates the relation between neuroticism and depressive symptoms. Personal Individ Differ. 2011;51:958-62.