The Irritable Bowel Syndrome Outcome Study (IBSOS): Rationale and design of a randomized, placebo-controlled trial with 12month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome

Contemporary Clinical Trials

Volumn 33, Issue 6, 2012, Pages 1293-1310

  Lackner, Jeffrey M ^a   Keefer, Laurie ^b   Jaccard, James ^c   Firth, Rebecca ^a   Brenner, Darren ^b   Bratten, Jason ^b   Dunlap, Laura J ^d   Ma, Changxing ^f   Byroads, Mark ^e  

^a UNIVERSITY AT BUFFALO   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

^c NEW YORK UNIVERSITY   (United States)

^d RTI INTERNATIONAL   (United States)

^e FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^f UNIVERSITY AT BUFFALO   (United States)

Author keywords

Cognitive behavior therapy; Comparative effectiveness; National Institute of Diabetes and Digestive and Kidney Diseases; Pain; Randomized clinical trial; Self management

Indexed keywords

ADULT; AGED; ARTICLE; COGNITIVE THERAPY; CONTROLLED STUDY; COST; DISTRESS SYNDROME; FEMALE; FOLLOW UP; HUMAN; IRRITABLE COLON; MAJOR CLINICAL STUDY; MALE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT RESPONSE;

ADOLESCENT; ADULT; AGED; COGNITIVE THERAPY; FEMALE; FOLLOW-UP STUDIES; HUMANS; IRRITABLE BOWEL SYNDROME; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; STRESS, PSYCHOLOGICAL; YOUNG ADULT;

EID: 84867197340     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2012.07.013     Document Type: Article

References (104)

1. Mayer E.A. Clinical practice. Irritable bowel syndrome. N Engl J Med 2008, 358(16):1692-1699.
2. Levy R.L., Von Korff M.R., Whitehead W.E., Stang P., Saunders K., Jhingran P., et al. Costs of care for irritable bowel syndrome patients in a health maintenance organization. Am J Gastroenterol 2001, 96(11):3122-3129.
3. Hahn B.A., Yan S., Strassels S. Impact of irritable bowel syndrome on quality of life and resource use in the United States and United Kingdom. Digestion 1999, 60:77-81.
4. Lackner J.M., Gudleski G.D., Zack M.M., Katz L.A., Powell C., Krasner S., et al. Measuring health-related quality of life in patients with irritable bowel syndrome: can less be more?. Psychosom Med 2006, 68(2):312-320.
5. Whitehead W.E., Burnett C.K., Cook EW, Taub E. Impact of irritable bowel syndrome on quality of life. Dig Dis Sci 1996, 41(11):2248-2253.
6. Camilleri M., Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology 2008, 135(6):1877-1891.
7. Von Korff M.R., Gruman J., Schaefer J., Curry S.J., Wagner E.H. Collaborative management of chronic illness. Ann Intern Med 1997, 127(12):1097-1102.
8. Levy R.L., Olden K.W., Naliboff B.D., Bradley L.A., Francisconi C., Drossman D.A., et al. Psychosocial aspects of the functional gastrointestinal disorders. Gastroenterology 2006, 130(5):1447-1458.
9. Department of Health Treatment choice in psychological therapies and counseling: evidence based clinical guidelines 2001, UK Department of Health, London.
10. Lackner J.M., Morley S., Dowzer C., Mesmer C., Hamilton S. Psychological treatments for irritable bowel syndrome: a systematic review and meta-analysis. J Consult Clin Psychol 2004, 72(6):1100-1113.
11. Lackner J.M., Jaccard J., Krasner S.S., Katz L.A., Gudleski G.D., Blanchard E.B. How does cognitive behavior therapy for irritable bowel syndrome work? A mediational analysis of a randomized clinical trial. Gastroenterology 2007, 133(2):433-444.
12. Lackner J.M., Jaccard J., Krasner S.S., Katz L.A., Gudleski G.D., Holroyd K. Self-administered cognitive behavior therapy for moderate to severe irritable bowel syndrome: clinical efficacy, tolerability, feasibility. Clin Gastroenterol Hepatol 2008, 6(8):899-906.
13. Holroyd K.A., O'Donnell F.J., Stensland M., Lipchik G.L., Cordingley G.E., Carlson B.W. Management of chronic tension-type headache with tricyclic antidepressant medication, stress management therapy, and their combination: a randomized controlled trial. JAMA 2001, 285(17):2208-2215.
14. Andresen V., Montori V.M., Keller J., West C.P., Layer P., Camilleri M. Effects of 5-hydroxytryptamine (serotonin) type 3 antagonists on symptom relief and constipation in nonconstipated irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol 2008, 6(5):545-555.
15. Barlow D.H., Gorman J.M., Shear M.K., Woods S.W. Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: a randomized controlled trial. JAMA 2000, 283(19):2529-2536.
16. Hellerstein D.J., Yanowitch P., Rosenthal J., Samstag L.W., Maurer M., Kasch K., et al. A randomized double-blind study of fluoxetine versus placebo in the treatment of dysthymia. Am J Psychiatry 1993, 150(8):1169-1175.
17. Hudson J.I., McElroy S.L., Raymond N.C., Crow S., Keck P.E., Carter W.P., et al. Fluvoxamine in the treatment of binge-eating disorder: a multicenter placebo-controlled, double-blind trial. Am J Psychiatry 1998, 155(12):1756-1762.
18. Zaider T.I., Heimberg R.G., Fresco D.M., Schneier F.R., Liebowitz M.R. Evaluation of the clinical global impression scale among individuals with social anxiety disorder. Psychol Med 2003, 33(4):611-622.
19. Talley N.J., Locke G.R., Herrick L.M., Silvernail V.M., Prather C.M., Lacy B.E., et al. Functional Dyspepsia Treatment Trial (FDTT): A double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics. Contemp Clin Trials 2012, 33(3):523-533.
20. Gordon S., Ameen V., Bagby B., Shahan B., Jhingran P., Carter E. Validation of irritable bowel syndrome Global Improvement Scale: an integrated symptom end point for assessing treatment efficacy. Dig Dis Sci 2003, 48(7):1317-1323.
21. Mangel A.W., Hahn B.A., Heath A.T., Northcutt A.R., Kong S., Dukes G.E., et al. Adequate relief as an endpoint in clinical trials in irritable bowel syndrome. J Int Med Res 1998, 26(2):76-81.
22. Jensen M.P., Karoly P., Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain 1986, 27(1):117-126.
23. Dworkin R.H., et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005, 113(1-2):9-19.
24. Melzack R. The short form McGill pain questionnaire. Pain 1987, 30:191-197.
25. Francis C.Y., Morris J., Whorwell P.J. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther 1997, 11(2):395-402.
26. Drossman D.A., Patrick D.L., Whitehead W.E., Toner B.B., Diamant N.E., Hu Y., et al. Further validation of the IBS-QOL: a disease-specific quality-of-life questionnaire. Am J Gastroenterol 2000, 95(4):999-1007.
27. Bushnell D.M., Martin M.L., Ricci J.F., Bracco A. Performance of the EQ-5D in patients with irritable bowel syndrome. Value Health 2006, 9(2):90-97.
28. Ware J., Kosinski M., Keller S.D. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34(3):220-233.
29. Lewis S.J., Heaton K.W. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 1997, 32(9):920-924.
30. Larsen D.L., Attkisson C.C., Hargreaves W.A., Nguyen T.D. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann 1979, 2(3):197-207.
31. Derogatis L.R. Brief Symptom Inventory 1993, National Computer Systems, Minneapolis, MN.
32. Spielberger C.D., Gorsuch R.L., Lushene R.E. Manual for the State-Trait Anxiety Inventory 1970, Consulting Psychologist Press, Palo Alto, CA.
33. Beck A.T., Steer R., Brown G. Beck Depression Inventory-II Manual 1996, Harcourt Assessment, San Antonio, Texas.
34. Rief W., Hiller W. A new approach to the assessment of the treatment effects of somatoform disorders. Psychosomatics 2003, 44(6):492-498.
35. Lackner J.M., Gudleski G.D., Keefer L., Krasner S.S., Powell C., Katz L.A. Rapid response to cognitive behavior therapy predicts treatment outcome in patients with irritable bowel syndrome. Clin Gastroenterol Hepatol 2010, 8:426-432.
36. Kraemer H.C., Wilson G.T., Fairburn C.G., Agras W.S. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry 2002, 59(10):877-883.
37. Baron R.M., Kenny D.A. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol 1986, 51(6):1173-1182.
38. Owens E.B., Hinshaw S.P., Kraemer H.C., Arnold L.E., Abikoff H.B., Cantwell D.P., et al. Which treatment for whom for ADHD? Moderators of treatment response in the MTA. J Consult Clin Psychol 2003, 71(3):540-552.
39. Paul G. Strategy of outcome research in psychotherapy. J Consult Psychol 1967, 31:109-118.
40. Horowitz L.M., Alden L.E., Wiggins J.S., Pincus A.L. IIP Inventory of Interpersonal Problems Inventory manual 2000, Psychological Corporation, San Antonio, TX.
41. Lackner J.M., Deci E.L. Treatment self regulation questionnaire for IBS (a self report questionnaire of treatment motivation specific to IBS patients) 2004, University at Buffalo, SUNY Buffalo.
42. Review of empirical studies on cognitive therapy. Psychiatry update: American Psychiatric Association annual review 1988, vol. 7:643-666. American Psychiatric Press, Washington, DC. S.D. Hollon, L. Najavits (Eds.).
43. Kazdin A.E., Nock M.K. Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations. J Child Psychol Psychiatry 2003, 44(8):1116-1129.
44. Naliboff B., Lackner J.M., Mayer E. Psychosocial factors in the care of patients with functional gastrointestinal disorders. Principles of clinical gastroenterology 2008, 20-37. John Wiley & Sons. T. Yamada (Ed.).
45. Lackner J.M., Krasner S.S., Holroyd K. IBS Management Self Efficacy Scale 2004, University at Buffalo, SUNY, Buffalo.
46. Lackner J.M., Holroyd K. Locus of control scale-IBS version (a self report measure for assessing perceived control in IBS patients) 2004, University at Buffalo, SUNY, Buffalo.
47. Labus J.S., Bolus R., Chang L., Wiklund I., Naesdal J., Mayer E.A., et al. The Visceral Sensitivity Index: development and validation of a gastrointestinal symptom-specific anxiety scale. Aliment Pharmacol Ther 2004, 20(1):89-97.
48. Peterson R.A., Reiss S. Anxiety Sensitivity Index: revised test manual 1993, IDS Publishing Corporation, Worthington.
49. Frank J.D. Persuasion and healing 1961, Johns Hopkins University, New York.
50. Wampold B.E. The great psychotherapy debate: models, methods, and findings 2001, Lawrence Erlbaum Associates, Mahwah, NJ.
51. Goldfried M.R. Toward the delineation of therapeutic change. Am Psychol 1980, 35:991-999.
52. Beitman B.D., Goldfried M.R., Norcross J.C. The movement toward integrating the psychotherapies: an overview. Am J Psychiatry 1989, 146(2):138-147.
53. Thase M.E., Friedman E.S., Berman S.R., Fasiczka A.L., Lis J.A., Howland R.H., et al. Is cognitive behavior therapy just a 'nonspecific' intervention for depression? A retrospective comparison of consecutive cohorts treated with cognitive behavior therapy or supportive counseling and pill placebo. J Affect Disord 2000, 57(1-3):63-71.
54. Kaufman N.K., Rohde P., Seeley J.R., Clarke G.N., Stice E. Potential mediators of cognitive-behavioral therapy for adolescents with comorbid major depression and conduct disorder. J Consult Clin Psychol 2005, 73(1):38-46.
55. Rozenzweig S. Some implicit common factors in diverse methods of psychotherapy. Am J Orthopsychiatry 1936, 6:412-415.
56. Castonguay L.G. "Common factors" and "nonspecific variables": Clarification of the two concepts and recommendations for research. J Psychother Integr 1993, 3:267-286.
57. Stiles W., Shapiro D., Elliott R. Are all psychotherapies equivalent?. Am Psychol 1986, 41:165-180.
58. Strupp H.H., Hadley S.W. Specific vs. nonspecific factors in psychotherapy. A controlled study of outcome. Arch Gen Psychiatry 1979, 36(10):1125-1136.
59. Munder T., Wilmers F., Leonhart R., Linster H.W., Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother 2010, 17(3):231-239.
60. Agras W.S., Crow S.J., Halmi K.A., Mitchell J.E., Wilson G.T., Kraemer H.C. Outcome predictors for the cognitive behavior treatment of bulimia nervosa: data from a multisite study. Am J Psychiatry 2000, 157(8):1302-1308.
61. Irvine E.J., Whitehead W.E., Chey W.D., Matsueda K., Shaw M., Talley N.J., et al. Design of treatment trials for functional gastrointestinal disorders. Gastroenterology 2006, 130(5):1538-1551.
62. Carroll K.M. Enhancing retention in clinical trials of psychosocial treatments: practical strategies. Beyond the therapeutic alliance: keeping the drug-dependent individual in treatment 1997, 4-24. National Institute on Drug Abuse, Rockville, MD. L.S. Onken, J.D. Blaine, J.J. Boren (Eds.).
63. Longstreth G.F., Thompson W.G., Chey W.D., Houghton L.A., Mearin F., Spiller R.C. Functional bowel disorders. Gastroenterology 2006, 130(5):1480-1491.
64. Vanner S.J., Depew W.T., Paterson W.G. Predictive value of the Rome criteria for diagnosing the irritable bowel syndrome. Am J Gastroenterol 1999, 94:2912-2917.
65. Cash B.D., Schoenfeld P., Chey W.D. The utility of diagnostic tests in irritable bowel syndrome patients: a systematic review. Am J Gastroenterol 2002, 97(11):2812-2819.
66. Ford A.C., Chey W.D., Talley N.J., Malhotra A., Spiegel B.M., Moayyedi P. Yield of diagnostic tests for celiac disease in individuals with symptoms suggestive of irritable bowel syndrome: systematic review and meta-analysis. Arch Intern Med 2009, 169(7):651-658.
67. Mein S.M., Ladabaum U. Serological testing for coeliac disease in patients with symptoms of irritable bowel syndrome: a cost-effectiveness analysis. Aliment Pharmacol Ther 2004, 19(11):1199-1210.
68. Talley N.J. Diagnosis and management of the irritable bowel syndrome Available from:. http://www.medscape.org/viewarticle/480231.
69. Blanchard E.B., Lackner J.M., Sanders K., Krasner S., Keefer L., Payne A., et al. A controlled evaluation of group cognitive therapy in the treatment of irritable bowel syndrome. Behav Res Ther 2007, 45:633-648.
70. Abelson R. In Health Shift, Pharmacists Take Larger Role on Health Team, in, New York Times 2010.
71. AAFP Cogntive behavior therapy for irritable bowel syndrome 2012, FP Audio.
72. Lackner J.M., Gudleski G.D., Keefer L., Krasner S.S., Powell C., Katz L.A. Rapid response to cognitive behavior therapy predicts treatment outcome in patients with irritable bowel syndrome. Clin Gastroenterol Hepatol 2010, 8(5):426-432.
73. Blanchard E.B. Irritable bowel syndrome: psychosocial assessment and treatment 2000, APA, Washington.
74. Bandura A. Social foundations of thought and action: a social cognitive theory 1986, Prentice-Hall, Englewood Cliffs, N.J.
75. Payne A., Blanchard E.B. A controlled comparison of cognitive therapy and self-help support groups in the treatment of irritable bowel syndrome. J Consult Clin Psychol 1995, 63:779-786.
76. Drossman D.A., Toner B.B., Whitehead W.E., Diamant N.E., Dalton C.B., Duncan S., et al. Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders. Gastroenterology 2003, 125(1):19-31.
77. Turner J.A., Mancl L., Aaron L.A. Short- and long-term efficacy of brief cognitive-behavioral therapy for patients with chronic temporomandibular disorder pain: a randomized, controlled trial. Pain 2006, 121(3):181-194.
78. Blanchard E.B. Irritable bowel syndrome: psychosocial assessment and treatment 2001, APA, Washington.
79. Craske M.G., Maidenberg E., Bystritsky A. Brief cognitive-behavioral versus nondirective therapy for panic disorder. J Behav Ther Exp Psychiatry 1995, 26(2):113-120.
80. Lackner J.M., Jaccard J., Blanchard E.B. Testing the sequential model of pain processing in irritable bowel syndrome: a structural equation modeling analysis. Eur J Pain 2005, 9:207-218.
81. Last C.G., Hansen C., Franco N. Cognitive-behavioral treatment of school phobia. J Am Acad Child Adolesc Psychiatry 1998, 37(4):404-411.
82. Silverman W.K., Kurtines W.M., Ginsburg G.S., Weems C.F., Rabian B., Serafini L.T. Contingency management, self-control, and education support in the treatment of childhood phobic disorders: a randomized clinical trial. J Consult Clin Psychol 1999, 67(5):675-687.
83. Heimberg R.G., Dodge C.S., Hope D.A., Kennedy C.R., Zolla L.J. Cognitive behavioral group treatment for social phobia: comparison with a credible placebo condition. Cognit Ther Res 1990, 14:1-23.
84. Gordon D. IBS: learn to take charge of it 2004, Barnes & Noble, New York.
85. Deviliya G.J., Borkovec T.D. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000, 31(2):73-86.
86. Welleck S. Testing statistical hypotheses of equivalence 2002, Chapman, New York.
87. Duncan T., Duncan S., Strycker L., Li F., Albert A. An introduction to latent variable growth curve modeling: concepts, issues, and applications 1999, Sage, Newbury Park.
88. Drummond M.F., Schulpher M.J., Torrance G.W., O'Brien B.J., Stoddart G.L. Methods for the economic evaluation of health care programmes 2005, Oxford University Press, New York. 3rd ed.
89. Siegel J.E., Weinstein M.C., Russell L.B., Gold M.R. Recommendations for reporting cost-effectiveness analyses. Panel on cost-effectiveness in health and medicine. JAMA 1996, 276(16):1339-1341.
90. Glick H.A., Doshi J.A., Sonnad S.S., Plosky D. Economic evaluation in clinical trials 2007, Oxford University Press, New York.
91. Fenwick E., Claxton K., Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ 2001, 10(8):779-787.
92. Fenwick E., Marshall D.A., Levy A.R., Nichol G. Using and interpreting cost-effectiveness acceptability curves: an example using data from a trial of management strategies for a trial fibrillation. BMC Health Serv Res 2006, 6(1):52-59.
93. Jackson D. Revisiting sample size and number of parameter estimates: some support for the N:q hypothesis. Struct Equ Modeling 2003, 10:128-141.
94. Jaccard J., Turrisi R. LISREL analyses of interaction effects in multiple regression 1996, Sage, Newbury Park.
95. Wellek S. Testing statistical hypotheses of equivalence and noninferiority 2003, Chapman & Hall/CRC, Boca Raton, FL. 2nd ed.
96. Drossman D., Morris C.B., Hu Y., Toner B.B., Diamant N., Whitehead W.E., et al. Characterization of health related quality of life (HRQOL) for patients with functional bowel disorder (FBD) and its response to treatment. Am J Gastroenterol 2007, 102:1442-1453.
97. Raudenbush S.W., Liu X. Statistical power and optimal design for multisite randomized trials. Psychol Methods 2000, 5(2):199-213.
98. Perepletchikova F., Kazdin A.E. Treatment integrity and therapeutic change: issues and research recommendations. Clin Psychol Sci Pract 2005, 12(4):365-383.
99. Borrelli B., Sepinwall D., Ernst D., Bellg A.J., Czajkowski S., Breger R., et al. A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behavior research. J Consult Clin Psychol 2005, 73(5):852-860.
100. Sechrest L., West S.G., Phillips M.A., Redner R., Yeaton W. Some neglected problems in evaluation research: strength and integrity of treatments. Evaluation studies review annual 1979, 15-35. Sage, Beverly Hills. L. Sechrest (Ed.).
101. Elkin I., Shea M.T., Watkins J.T., Imber S.D., Sotsky S.M., Collins J.F., et al. National Institute of Mental Health Treatment of Depression Collaborative research program. General effectiveness of treatments. Arch Gen Psychiatry 1989, 46(11):971-982. [discussion 983].
102. Hollon S.D., DeRubeis R.J., Evans M.D., Wiemer M.J., et al. Cognitive therapy and pharmacotherapy for depression: singly and in combination. Arch Gen Psychiatry 1992, 49(10):774-781.
103. Rush A.J., Beck A.T., Kovacs M., Hollon S.D. Comparative efficacy of cognitive therapy and pharmacotherapy in the treatment of depressed outpatients. Cognit Ther Res 1977, 1:17-37.
104. Kendall P.C., Gosch E., Furr J.M., Sood E. Flexibility within fidelity. J Am Acad Child Adolesc Psychiatry 2008, 47(9):987-993.