Designing Rigorous Methods in Integrative Research: Comparing Mindfulness-Based Stress Reduction with the Health Enhancement Program in the Treatment of Urge Urinary Incontinence in Older Adult Women
DOI:
https://doi.org/10.14738/jbemi.92.11949Abstract
Older adult women are marginalized in scientific research. Prior research has been done studying the treatment of urinary urge incontinence through mindfulness-based stress reduction. The highest prevalence of urinary urge incontinence is found in older adult women, yet this is the first study to treat older adult women who have urge urinary incontinence with mindfulness-based stress reduction.
The methods of a rigorous pilot feasibility and randomized controlled trial are described from study design through completion. Preparations, procedures, and execution of the study including measures, data management, and statistical analyses are delineated. Considerations necessary due to the specific population are explained.
Authors discuss significant characteristics, results, and successes and difficulties embedded in the methods used.
References
Baker J, Costa D, Guarino JM, Nygaard I. Comparison of mindfulness-based stress reduction versus yoga on urinary urge incontinence: A randomized pilot study with 6-month and 1-year follow-up visits. Female Pelvic Med Reconstr Surg. 2014;20(3):141-146.
Baker J, Costa D, Nygaard I. Mindfulness-based stress reduction for treatment of urinary urge incontinence: A pilot study. Female Pelvic Med Reconstr Surg. 2012;18(1):46-49.
Felsted KF, Supiano, KP. Using mindfulness approaches to treat urinary urge incontinence in older adult women: A scoping review. IJNH. 2019;2(1):42-50.
Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A metaanalysis. J Psychosom Res. 2004;57(1):35-43.
Kabat-Zinn J. Bringing mindfulness to medicine: An interview with Jon Kabat-Zinn, PhD. Interview by Karolyn Gazella. Adv Mind Body Med. 2005;21(2):22-27.
MacCoon DG, Imel ZE, Rosenkranz MA, et al. The validation of an active control intervention for mindfulness-based stress reduction (MBSR). Behav Res Ther. 2012;50(1):3-12.
Felsted KF, Supiano KP. Mindfulness-Based Stress Reduction vs a Health Enhancement Program in the treatment of urge urinary incontinence in older adult women: A randomized controlled feasibility study. Res Gerontol Nurs. 2019; 12(6): 285-297.
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45(5):626-629.
McHenry JC, Insel KC, Einstein GO, Vidrine AN, Koerner KM, Morrow DG. Recruitment of older adults: Success may be in the details. Gerontologist. 2015;55(5):845-853.
Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: A brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695-699.
Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207.
Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials. BMC Med. 2010; 8:18.
Mohr DC, Spring B, Freedland KE, et al. The selection and design of control conditions for randomized controlled trials of psychological interventions. Psychother Psychosom. 2009;78(5):275-284.
Ospina MB, Bond K, Karkhaneh M, et al. Clinical trials of meditation practices in health care: Characteristics and quality. J Altern Complement Med. 2008;14(10):1199-1213.
Wesson J, Clemson L, Brodaty H, et al. A feasibility study and pilot randomized trial of a tailored prevention program to reduce falls in older people with mild dementia. BMC Geriatr. 2013; 13:89.
Leon AC, Mallinckrodt CH, Chuang-Stein C, Archibald DG, Archer GE, Chartier K. Attrition in randomized controlled clinical trials: Methodological issues in psychopharmacology. Biol Psychiatry. 2006;59(11):1001-1005.
Nezu AM, Nezu CM. Evidence-Based Outcome Research: A Practical Guide to Conducting Randomized Controlled Trials for Psychological Interventions. New York: Oxford University Press; 2008.
Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011;4(5):332-337.
Sturdy G, Hillman D, Green D, Jenkins S, Cecins N, Eastwood P. Feasibility of high-intensity, interval-based respiratory muscle training in COPD. Chest. 2003;123(1):142-150.
Sandvik H, Espuna M, Hunskaar S. Validity of the incontinence severity index: Comparison with pad-weighing tests. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17(5):520-524.
Sandvik H, Seim A, Vanvik A, Hunskaar S. A severity index for epidemiological surveys of female urinary incontinence: Comparison with 48-hour pad-weighing tests. Neurourol Urodyn. 2000;19(2):137-145.
Coyne KS, Thompson CL, Lai JS, Sexton CC. An overactive bladder symptom and health-related quality of life shortform: Validation of the OAB-q SF. Neurourol Urodyn. 2015;34(3):255-263.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav.1983;24(4):385-396.
Cohen S, Kessler, R.C., Underwood Gordon, L. Measuring Stress: A Guide for Health and Social Scientists. New York: Oxford University Press; 1995.
Cohen S, Williamson, G. Perceived stress in a probability sample of the United States. In Spacapan S, Oskamp, S. eds. The Social Psychology of Health. Newbury Park, CA: Sage Publishers; 1988.
Tannenbaum C, Brouillette J, Michaud J, et al. Responsiveness and clinical utility of the geriatric self-efficacy index for urinary incontinence. J Am Geriatr Soc. 2009;57(3):470-475.
Tannenbaum C, Brouillette J, Korner-Bitensky N, et al. Creation and testing of the Geriatric Self- Efficacy Index for Urinary Incontinence. J Am Geriatr Soc. 2008;56(3):542-547.
Yalcin IB, R. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003;189:98-101.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 1996; World Health Organization, 2005
Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation. Geneva, Switzerland: World Health Organization; 2005.
Harris, PA, Taylor, R, Thielke, R, Payne, J, Gonzalez, N, Conde, JG. Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform, 2009 Apr; 42(2): 377-81.
Harris, PA, Taylor, R, Minor, BL, Elliott, V, Fernandez, M, O’Neal, L, McLeod, L, Delacqua, G, Delacqua, F, Kirby, J, Duda, SN. REDCap Consortium, The REDCap consortium: Building an international community of software partners, J Biomed Inform, 2019 May 9 doi: 10.1016/j.jbi.2019.103208
IBM Corp. (2013). IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp.
StataCorp. (2017). Stata Statistical Software: Release 15. College Station, TX: StataCorp LLC.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2022 Katarina Friberg Felsted
This work is licensed under a Creative Commons Attribution 4.0 International License.
