Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Mindfulness-based exposure and response prevention for obsessive compulsive disorder: study protocol for a pilot randomised controlled trial

Authors: Clara Strauss, Claire Rosten, Mark Hayward, Laura Lea, Elizabeth Forrester, Anna-Marie Jones

Published in: Trials | Issue 1/2015

Login to get access

Abstract

Background

Obsessive Compulsive Disorder (OCD) is a distressing and debilitating condition affecting 1-2% of the population. Exposure and response prevention (ERP) is a behaviour therapy for OCD with the strongest evidence for effectiveness of any psychological therapy for the condition. Even so, only about half of people offered ERP show recovery after the therapy. An important reason for ERP failure is that about 25% of people drop out early, and even for those who continue with the therapy, many do not regularly engage in ERP tasks, an essential element of ERP. A mindfulness-based approach has the potential to reduce drop-out from ERP and to improve ERP task engagement with an emphasis on accepting difficult thoughts, feelings and bodily sessions and on becoming more aware of urges, rather than automatically acting on them.

Methods/Design

This is a pilot randomised controlled trial of mindfulness-based ERP (MB-ERP) with the aim of establishing parameters for a definitive trial. Forty participants diagnosed with OCD will be allocated at random to a 10-session ERP group or to a 10-session MB-ERP group. Primary outcomes are OCD symptom severity and therapy engagement. Secondary outcomes are depressive symptom severity, wellbeing and obsessive-compulsive beliefs. A semi-structured interview with participants will guide understanding of change processes.

Discussion

Findings from this pilot study will inform future research in this area, and if effect sizes on primary outcomes are in favour of MB-ERP in comparison to ERP, funding for a definitive trial will be sought.

Trial registration

Current Controlled Trials registration number ISRCTN52684820. Registered on 30 January 2014.
Literature
1.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Washington DC: APA; 2013.
2.
National Institute of Health and Care Excellence [NICE]. Obsessive-compulsive disorder: core interventions in the treatment of obsessive-compulsive disorder and body dysmorphic disorder. London: NICE; 2005.
3.
Najmi S, Kuckertz JM, Amir N. Automatic avoidance tendencies in individuals with contamination-related obsessive-compulsive symptoms. Behav Res Ther. 2010;48:1058–62.CrossRefPubMedPubMedCentral
4.
Meyer V. Modification of expectations in cases with obsessional rituals. Behav Res Ther. 1966;4:273–80.CrossRefPubMed
5.
Jónsson H, Hougaard E. Group cognitive behavioural therapy for obsessive-compulsive disorder: a systematic review and meta-analysis. Acta Psychiatr Scand. 2009;119:98–106.CrossRefPubMed
6.
Anderson RA, Rees CS. Group versus individual cognitive-behavioural treatment for obsessive-compulsive disorder: a controlled trial. Behav Res Ther. 2007;45:123–37.CrossRefPubMed
7.
Whittal ML, Thordarson DS, McLean PD. Treatment of obsessive-compulsive disorder: cognitive behavior therapy vs. exposure and response prevention. Behav Res Ther. 2005;43:1559–76.CrossRefPubMed
8.
Aderka IM, Anholt GE, van Balkom AJLM, Smit JH, Hermesh H, Hofmann SG, et al. Differences between early and late drop-outs from treatment for obsessive-compulsive disorder. J Anxiety Disord. 2011;25:918–23.CrossRefPubMed
9.
Cougle JR, Timpano KR, Fitch KE, Hawkins KE. Distress tolerance and obsessions: an integrative analysis. Depress Anxiety. 2011;28:906–14.CrossRefPubMed
10.
Simpson HB, Maher MJ, Wang Y, Franklin M. Patient adherence predicts outcome from cognitive-behavioral therapy in obsessive-compulsive disorder. J Consult Clin Psychol. 2011;79:247–52.CrossRefPubMedPubMedCentral
11.
Kabat-Zinn J. Full catastrophe living: using the wisdom of your body and mind to face stress, pain and illness. New York: Delacorte; 1990.
12.
Segal ZV, Williams JMG, Teasdale JD. Mindfulness-based cognitive therapy for depression. New York: Guildford Press; 2002.
13.
Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003;84:822–48.CrossRefPubMed
14.
15.
Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits: a meta-analysis. J Psychosom Res. 2004;57:35–43.CrossRefPubMed
16.
Chiesa A, Serretti A. A systematic review of neurobiological and clinical features of mindfulness meditations. Psychol Med. 2010;40:1239–52.CrossRefPubMed
17.
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;78:169–83.CrossRefPubMedPubMedCentral
18.
Strauss C, Cavanagh K, Oliver A, Pettman D. Mindfulness-based interventions for people diagnosed with a current episode of an anxiety or depressive disorder: a meta-analysis of randomised controlled trials. PLoS One. 2014;9, e96110.CrossRefPubMedPubMedCentral
19.
Eberth J, Sedlmeier P. The effects of mindfulness meditation: a meta-analysis. Mindfulness (N Y). 2012;3:174–89.CrossRef
20.
Sedlmeier P, Eberth J, Schwarz M, Zimmermann D, Haarig F, Jaeger S, et al. The psychological effects of meditation: a meta-analysis. Psychol Bull. 2012;138:1139–71.CrossRefPubMed
21.
Hale L, Strauss C, Taylor BL. The effectiveness and acceptability of mindfulness-based therapy for obsessive compulsive disorder: a review of the literature. Mindfulness (N Y). 2013;4:375–82.CrossRef
22.
23.
Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;10:67.CrossRefPubMedPubMedCentral
24.
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45:626–9.CrossRefPubMed
25.
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4:287–91.CrossRef
26.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders (Fourth Edition). Washington DC: American Psychiatric Association; 1994.
27.
Sheehan D, Lecrubier Y. Mini International neuropsychiatric interview. 2010.
28.
Storch EA, Rasmussen SA, Price LH, Lawrence H, Larson MJ, Murphy TK, et al. Development and psychometric evaluation of the Yale–Brown Obsessive-Compulsive Scale-Second Edition. Psychol Assess. 2010;22:223–32.CrossRefPubMed
29.
NHS Health Scotland & University of Warwick & University of Edinburgh. Short Warwick-Edinburgh Mental Well-Being Scale. Edinburgh: NHS; 2007.
30.
Stewart-Brown SL, Platt S, Tennant A, Maheswaran H, Parkinson J, Weich S, et al. The Warwick-Edinburgh mental well-being scale: a valid and reliable tool for measuring mental well-being in diverse populations and projects. J Epidemiol Community Heal. 2011;65(Suppl2):A38–9.CrossRef
31.
Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-II. San Antonio, Texas: Psychological Corporation; 1996.
32.
Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer RA. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011;18:308–20.CrossRefPubMed
33.
Obsessive Compulsive Cognitions Working Group. Psychometric validation of the obsessive belief questionnaire and interpretation of intrusions inventory-Part 2: factor analyses and testing of a brief version. Behav Res Ther. 2005;43:1527–42.CrossRef
34.
Elliott R, Slatick E, Urman M. Qualitative change process research on psychotherapy: alternative strategies. In: Frommer J, Rennie DL, editors. Qual Psychother Res Methods Methodol. Lengerich, Germany: Pabst Science; 2001. p. 69–111.
35.
Abramowitz JS, Arch JJ. Strategies for improving long-term outcomes in cognitive behavioral therapy for obsessive-compulsive disorder: insights from learning theory. Cogn Behav Pract. 2014;21:20–31.CrossRef
36.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3:77–101.CrossRef
37.
Clark DA. Focus on “cognition” in cognitive behaviour therapy for OCD: is it really necessary? Cogn Behav Ther. 2005;34:131–9.CrossRefPubMed
Metadata
Title
Mindfulness-based exposure and response prevention for obsessive compulsive disorder: study protocol for a pilot randomised controlled trial
Authors
Clara Strauss
Claire Rosten
Mark Hayward
Laura Lea
Elizabeth Forrester
Anna-Marie Jones
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0664-7

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Research

Effects of motivational interviewing-based adherence therapy for schizophrenia spectrum disorders: a randomized controlled trial

Study protocol

Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial

Study protocol

Comparative effectiveness of electro-acupuncture plus lifestyle modification treatment for patients with simple obesity and overweight: study protocol for a randomized controlled trial

Study protocol

Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial

Research

Similarities and differences between patients included and excluded from a randomized clinical trial of vitamin d supplementation for improving glucose tolerance in prediabetes: interpreting broader applicability

Study protocol

Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis (the BiCARB trial)? Study protocol for a randomized controlled trial