Abstract
While a large body of controlled empirical research has demonstrated the treatment efficacy of MBIs, whether these treatment effects are effective is less well-established. A significant hindrance lies within deviations from the original study protocol, as protocol deviation challenges the validity of an intervention. The present study explored methodological trends in how protocol deviation is dealt with in the mindfulness literature. Studies published between 2011 and 2016 were selected for the review based on the following inclusion criteria: (a) mindfulness is the main component of an intervention, (b) randomized and controlled intervention, (c) clinical sample, and (d) report of per-protocol and intention-to-treat statistical analysis. Review results indicate that mindfulness RCT studies suffer from relatively high rates of participant dropout and that statistical methods used to address protocol deviation may not be enough to control for the likelihood of bias. Furthermore, information regarding participants’ decision to discontinue study participation is not properly collected and assessed in many studies. This lack of attention to protocol deviation may prevent translating treatment efficacy of MBIs into treatment effectiveness.
Similar content being viewed by others
References
Armijo-Olivo, S., Warren, S., & Magee, D. (2009). Intention to treat analysis, compliance, drop-outs and how to deal with missing data in clinical research: a review. Physical Therapy Reviews, 14(1), 36–49.
Baker, J., Costa, D., Guarino, J. M., & Nygaard, I. (2014). 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 Medicine and Reconstructive Surgery, 20(3), 141–146.
Carlson, L. E., Doll, R., Stephen, J., Faris, P., Tamagawa, R., Drysdale, E., et al. (2013). Randomized controlled trial of mindfulness-based cancer recovery versus supportive expressive group therapy for distressed survivors of breast cancer (MINDSET). Journal of Clinical Oncology, 31(25), 3676–3687.
Collip, D., Geschwind, N., Peeters, F., Myin-Germeys, I., van Os, J., & Wichers, M. (2013). Putting a hold on the downward spiral of paranoia in the social world: a randomized controlled trial of mindfulness-based cognitive therapy in individuals with a history of depression. PloS One, 8(6), e66747.
Corsica, J., Hood, M. M., Katterman, S., Kleinman, B., & Ivan, I. (2014). Development of a novel mindfulness and cognitive behavioral intervention for stress-eating: a comparative pilot study. Eating Behaviors, 15(4), 694–699.
Crane, C., & Williams, J. M. G. (2010). Factors associated with attrition from mindfulness-based cognitive therapy in patients with a history of suicidal depression. Mindfulness, 1(1), 10–20.
Day, M. A., Thorn, B. E., Ward, L. C., Rubin, N., Hickman, S. D., Scogin, F., et al. (2014). Mindfulness-based cognitive therapy for the treatment of headache pain a pilot study. Clinical Journal of Pain, 30(2), 152–161.
Flay, B. R. (1986). Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. Preventative Medicine, 15(5), 451–474.
Flay, B. R., Biglan, A., Boruch, R. F., Castro, F. G., Gottfredson, D., Kellam, S., et al. (2005). Standards of evidence: criteria for efficacy, effectiveness and dissemination. Prevention Science, 6(3), 151–175.
Garland, E. L., Manusov, E. G., Froeliger, B., Kelly, A., Williams, J. M., & Howard, M. O. (2014b). Mindfulness-oriented recovery enhancement for chronic pain and prescription opioid misuse: results from an early-stage randomized controlled trial. Journal of Consulting and Clinical Psychology, 82(3), 448–459.
Garland, S. N., Carlson, L. E., Stephens, A. J., Antle, M. C., Samuels, C., & Campbell, T. S. (2014a). Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: a randomized, partially blinded, noninferiority trial. Journal of Clinical Oncology, 32(5), 449–457.
Glasgow, R. E., Lichtenstein, E., & Marcus, A. C. (2003). Why don't we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition. American Journal of Public Health, 93(8), 1261–1267.
Grossman, P., Niemann, L., Schmidt, S., & Walach, H. (2004). Mindfulness-based stress reduction and health benefits. A meta-analysis. Journal of Psychosomatic Research, 57(1), 35–43.
Gupta, S. K. (2011). Intention-to-treat concept: a review. Perspectives in Clinical Research, 2(3), 109–112.
Harris, P. M. (1998). Attrition revisited. American Journal of Evaluation, 19(3), 293–305.
Hartmann, M., Kopf, S., Kircher, C., Faude-Lang, V., Djuric, Z., Augstein, F., et al. (2012). Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients design and first results of a randomized controlled trial (the Heidelberger diabetes and stress-study). Diabetes Care, 35(5), 945–947.
Hofmann, S. G., Sawyer, A. T., Witt, A. A., & Oh, D. (2010). The effect of mindfulness-based therapy on anxiety and depression: a meta-analytic review. Journal of Consulting and Clinical Psychology, 78(2), 169–183.
Hughes, J. W., Fresco, D. M., Myerscough, R., van Dulmen, M. H. M., Carlson, L. E., & Josephson, R. (2013). Randomized controlled trial of mindfulness-based stress reduction for prehypertension. Psychosomatic Medicine, 75(8), 721–728.
Huijbers, M. J., Spinhoven, P., Spijker, J., Ruhe, H. G., van Schaik, D. J. F., van Oppen, P., et al. (2015). Adding mindfulness-based cognitive therapy to maintenance antidepressant medication for prevention of relapse/recurrence in major depressive disorder: randomised controlled trial. Journal of Affective Disorders, 187, 54–61.
Jazaieri, H., Goldin, P. R., Werner, K., Ziv, M., & Gross, J. J. (2012). A randomized trial of MBSR versus aerobic exercise for social anxiety disorder. Journal of Clinical Psychology, 68(7), 715–731.
Kabat-Zinn, J. (1982). An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. General Hospital Psychiatry, 4(1), 33–47.
Kearney, D. J., McDermott, K., Malte, C., Martinez, M., & Simpson, T. L. (2013). Effects of participation in a mindfulness program for veterans with posttraumatic stress disorder: a randomized controlled pilot study. Journal of Clinical Psychology, 69(1), 14–27.
Khoury, B., Lecomte, T., Fortin, G., Masse, M., Therien, P., Bouchard, V., et al. (2013). Mindfulness-based therapy: a comprehensive meta-analysis. Clinical Psychology Review, 33(6), 763–771.
King, A. P., Erickson, T. M., Giardino, N. D., Favorite, T., Rauch, S. A. M., Robinson, E., et al. (2013). A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). Depression and Anxiety, 30(7), 638–645.
Kocovski, N. L., Fleming, J. E., Hawley, L. L., Huta, V., & Antony, M. M. (2013). Mindfulness and acceptance-based group therapy versus traditional cognitive behavioral group therapy for social anxiety disorder: a randomized controlled trial. Behaviour Research and Therapy, 51(12), 889–898.
Marcellus, L. (2004). Are we missing anything? Pursuing research on attrition. Canadian Journal of Nursing Research, 36(3), 82–98.
McManus, F., Surawy, C., Muse, K., Vazquez-Montes, M., & Mark Williams, J. G. (2012). A randomized clinical trial of mindfulness-based cognitive therapy versus unrestricted services for health anxiety (hypochondriasis). Journal of Consulting and Clinical Psychology, 80(5), 817–828.
Meadows, G. N., Shawyer, F., Enticott, J. C., Graham, A. L., Judd, F., Martin, P. R., et al. (2014). Mindfulness-based cognitive therapy for recurrent depression: a translational research study with 2-year follow-up. Australian and New Zealand Journal of Psychiatry, 48(8), 743–755.
Monti, D. A., Kash, K. M., Kunkel, E. J., Moss, A., Mathews, M., Brainard, G., et al. (2013). Psychosocial benefits of a novel mindfulness intervention versus standard support in distressed women with breast cancer. Psycho-Oncology, 22(11), 2565–2575.
Montori, V. M., & Guyatt, G. H. (2001). Intention-to-treat principle. Canadian Medical Association Journal, 165(10), 1339–1341.
Nathan, P. E., Stuart, S. P., & Dolan, S. L. (2000). Research on psychotherapy efficacy and effectiveness: between scylla and charybdis? Psychological Bulletin, 126(6), 964–981.
Nich, C., & Carroll, K. M. (2002). Intention-to-treat meets missing data: implications of alternate strategies for analyzing clinical trials data. Drug and Alcohol Dependence, 68(2), 121–130.
Porta, N., Bonet, C., & Cobo, E. (2007). Discordance between reported intention-to-treat and per protocol analysis. Journal of Clinical Epidemiology, 60(7), 663–669.
Rohde, P., Clarke, G. N., Mace, D. E., Jorgensen, J. S., & Seeley, J. R. (2004). An efficacy/effectiveness study of cognitive-behavioral treatment for adolescents with comorbid major depression and conduct disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 43(6), 660–668.
Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2002). Mindfulness-based cognitive therapy for depression: A new approach to preventing relapse: Guilford press. New York: NY.
Shallcross, A. J., Gross, J. J., Visvanathan, P. D., Kumar, N., Palfrey, A., Ford, B. Q.,.. . Mauss, I. B. (2015). Relapse prevention in major depressive disorder: mindfulness-based cognitive therapy versus an active control condition. Journal of Consulting and Clinical Psychology, 83(5), 964–975.
Shapiro, D. H. (1992). Adverse effects of meditation: a preliminary investigation of long-term meditators. International Journal of Psychosomatics, 39(1–4), 62–67.
Singal, A. G., Higgins, P. D., & Waljee, A. K. (2014). A primer on effectiveness and efficacy trials. Clinical and Translational Gastroenterology, 5, e45.
van Ravesteijn, H., Lucassen, P., Bor, H., van Weel, C., & Speckens, A. (2013). Mindfulness-based cognitive therapy for patients with medically unexplained symptoms: a randomized controlled trial. Psychotherapy and Psychosomatics, 82(5), 299–310.
Vøllestad, J., Sivertsen, B., & Nielsen, G. H. (2011). Mindfulness-based stress reduction for patients with anxiety disorders: evaluation in a randomized controlled trial. Behaviour Research and Therapy, 49(4), 281–288.
Wells, K. B. (1999). Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research. The American Journal of Psychiatry, 156(1), 5–10.
Westbrook, D., & Kirk, J. (2005). The clinical effectiveness of cognitive behaviour therapy: outcome for a large sample of adults treated in routine practice. Behaviour Research and Therapy, 43(10), 1243–1261.
Wong, S. Y.-S., Chan, F. W.-K., Wong, R. L.-P., Chu, M.-C., Lam, Y.-Y. K., Mercer, S. W., et al. (2011). Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial. The Clinical Journal of Pain, 27(8), 724–734.
Zernicke, K. A., Campbell, T. S., Blustein, P. K., Fung, T. S., Johnson, J. A., Bacon, S. L., et al. (2013). Mindfulness-based stress reduction for the treatment of irritable bowel syndrome symptoms: a randomized wait-list controlled trial. International Journal of Behavioral Medicine, 20(3), 385–396.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of Interest
Seungwon Nam and Tony Toneatto have no conflict of interest.
Rights and permissions
About this article
Cite this article
Nam, S., Toneatto, T. The Influence of Attrition in Evaluating the Efficacy and Effectiveness of Mindfulness-Based Interventions. Int J Ment Health Addiction 14, 969–981 (2016). https://doi.org/10.1007/s11469-016-9667-1
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11469-016-9667-1