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Protocol for a pilot randomised controlled trial of mindfulness-based cognitive therapy in youth with inflammatory bowel disease and depression
  1. Tatjana Ewais1,2,
  2. Jake Begun1,3,
  3. Maura Kenny4,5,
  4. Kai-Hsiang Chuang6,
  5. Johanna Barclay3,
  6. Karen Hay7,
  7. Steve Kisely2,8
  1. 1Mater Young Adult Health Centre, Mater Misericordiae Brisbane Ltd, South Brisbane, Queensland, Australia
  2. 2Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia
  3. 3Mater Research Institute-UQ, University of Queensland, Brisbane, Queensland, Australia
  4. 4Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia
  5. 5Teaching Faculty, Mindfulness Training Institute, Sydney, New South Wales, Australia
  6. 6Queensland Brain Institute, University of Queensland, Brisbane, Queensland, Australia
  7. 7Statistics Unit, QIMR Berghofer Medical Research Institute, Herston, Queensland, Australia
  8. 8Princess Alexandra Hospital, Metro South Hospital and Health Service, Woolloongabba, Queensland, Australia
  1. Correspondence to Dr Tatjana Ewais; tatjanaewais{at}gmail.com

Abstract

Introduction Inflammatory bowel disease (IBD) is a chronic autoinflammatory disease of the gastrointestinal tract with peak age of onset during adolescence and young adulthood. Adolescents and young adults (AYAs) with IBD experience higher depression rates compared with peers who are well or have other chronic conditions. Mindfulness-based interventions are of particular interest because of their potential to improve both the course of IBD and depression.

Methods and analysis This study is a parallel design, single-blind, pilot randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) in AYAs with IBD and depression. The trial aims to recruit 64 participants who will be randomly allocated to MBCT or treatment as usual. The primary outcome measure is the depression subscale score from the Depression, Anxiety and Stress Scale. Secondary outcomes include anxiety, stress, post-traumatic growth, IBD-related quality of life, illness knowledge, medication adherence, mindfulness, IBD activity, inflammatory markers, microbiome and brain neuroconnectivity changes. All outcomes other than neuroimaging will be collected at three time points: at baseline, at therapy completion and at 20 weeks. Neuroimaging will be conducted at baseline and at therapy completion. Mixed-effects linear and logistic regression modelling will be used to analyse continuous and dichotomous outcomes, respectively. Participants’ experiences will be explored through focus groups, and thematic analysis will be used to generate relevant themes.

Ethics and dissemination The protocol has been approved by the Mater Hospital Human Research Ethics Committee (HREC) and University of Queensland HREC. Trial findings will be published in peer-reviewed journals and will be presented at scientific conferences.

Trial registration number ACTRN12617000876392, U1111-1197-7370; Pre-results.

  • inflammatory bowel disease
  • mindfulness
  • young adult
  • randomised controlled trial

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors Study protocol was conceived and designed by TE and critically revised by SK, JBe, MK, KH, KC and JBa. Drafting of the paper was completed by TE. All authors edited the manuscript.

  • Funding This work was supported by a project grant from the Brain Injured Children’s Aftercare Recovery Endeavours (BICARE).

  • Competing interests None declared.

  • Ethics approval The study was approved by the ethics committees of the Mater Hospital and The University of Queensland in June 2017.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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