Effectiveness of Mindfulness-Based Cognitive Therapy in reducing psychological distress and improving sleep in patients with Inflammatory Bowel Disease: study protocol for a multicentre randomised controlled trial (MindIBD).
Milou M Ter Avest, Annelieke S M Van Velthoven, Anne E. M. Speckens, Gerard Dijkstra, Martin Dresler, Carmen S Horjus, Tessa E H Römkens, Ellen M Witteman, Willemijn A van Dop, Quirine M Bredero, Loes H C Nissen, Marloes J. Huijbers
BMC Psychology June 19, 2023 DOI: 10.1186/s40359-023-01127-0 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Study protocol for a prospective, multicentre, randomised controlled trial Randomized Peer reviewed |
|---|---|
| Sample size | 136 |
| Population | Patients with inflammatory bowel disease (IBD) in remission, aged 16 years and older, with at least mild psychological distress (HADS total score >= 11) |
| Interventions | Mindfulness-Based Cognitive Therapy (MBCT) Treatment As Usual (TAU) |
| Duration | Assessments at baseline and at 3, 6, 9 and 12 months follow-up |
| Measures | Hospital Anxiety and Depression Scale (HADS), actigraphy, electroencephalography recordings |
| Topics | Meditation |
| Keywords | Cost-effectiveness Crohn’s disease Inflammatory bowel disease Mindfulness-based cognitive therapy Psychological distress Randomised controlled trial Sleep quality Study protocol Ulcerative colitis |
| Registration | NCT04646785 |
| Key findings | The protocol describes a trial designed to test whether MBCT plus treatment as usual, compared with treatment as usual alone, reduces psychological distress in IBD patients, with secondary aims of assessing effects on sleep quality, fatigue, disease activity, perceived disease control, quality of life, positive mental health, and cost-effectiveness. No results are reported; the authors propose that if effective, MBCT could be a valuable addition to psychosocial care for IBD and possibly other chronic conditions. |
Abstract
Many patients with Inflammatory Bowel Diseases (IBD) suffer from psychological distress, fatigue and sleep disturbances, which are associated with reduced quality of life (QoL) and increased societal costs. Only limited psychosocial treatment options are available. As Mindfulness-Based Cognitive Therapy (MBCT) has demonstrated to improve psychological distress, QoL and sleep in other populations, MBCT might also be effective in patients with IBD. The MindIBD study is a prospective, multicentre, randomised controlled trial comparing MBCT plus Treatment As Usual (TAU) versus TAU alone in a targeted number of 136 IBD patients in remission, aged 16 years and older with at least mild psychological distress (Hospital Anxiety and Depression Scale (HADS) total score ≥ 11). Primary outcome is reduction of psychological distress post-intervention, measured by the HADS. In addition, the effect of MBCT on sleep quality (including actigraphy and electroencephalography recordings), fatigue, disease activity, perceived disease control, QoL and positive mental health will be examined. Assessments will be conducted at baseline and at 3, 6, 9 and 12 months follow-up. Cost-effectiveness will be determined and a process evaluation will be conducted. This study will provide valuable insight into the clinical effect of MBCT on psychological distress, sleep quality, fatigue and QoL in IBD patients and into the cost-effectiveness. If effective, MBCT can be a valuable addition to the available psychosocial interventions for patients with IBD. Moreover, findings from this study may also be applicable in patients with other chronic conditions. ClinicalTrials.gov: NCT04646785, registered on 30/11/2020.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 3
- Group-Delivered Mindfulness-Based Cognitive Therapy to Reduce Psychological Distress and Improve Sleep in Patients With Inflammatory Bowel Diseases: A Multicenter Randomized Controlled Trial (MindIBD). Inflammatory bowel diseases July 14, 2025
- Study protocol for the MIND-PD study: a randomized controlled trial to investigate clinical and biological effects of mindfulness-based cognitive therapy in people with Parkinson's disease. BMC Neurology June 25, 2024
- Acceptability and Feasibility of Mindfulness-Based Cognitive Therapy in Adults with Inflammatory Bowel Disease: A Mixed-Methods Study Mindfulness August 14, 2026
Cites 11
- Construct Validity of the Five Facet Mindfulness Questionnaire in Meditating and Nonmeditating Samples Assessment February 29, 2008
- The effect of mindfulness meditation on sleep quality: a systematic review and meta‐analysis of randomized controlled trials Annals of the New York Academy of Sciences December 21, 2018
- The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials Perspectives on Psychological Science February 16, 2021
- Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. PLoS One December 2, 2021
- How do mindfulness-based programmes improve anxiety, depression and psychological distress? A systematic review Current Psychology April 1, 2023
and 6 more in the library