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NCT04646785
Mindfulness-based Cognitive Therapy for Patients With Inflammatory Bowel Disease
NA trial testing Mindfulness-based cognitive therapy + TAU in Inflammatory Bowel Diseases in 142 participants. Completed in 3 October 2023.
3 October 2023
Quick facts
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 142 |
| Start date | 1 August 2021 |
| Primary completion | 3 October 2023 |
| Estimated completion | 3 October 2023 |
| Sites | 4 locations across Netherlands |
Drugs / interventions tested
- Mindfulness-based cognitive therapy + TAU
- Treatment as usual (TAU) — full drug profile →
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
Sponsor
Radboud University Medical Center
Who can join
16 and older, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Considering the limited availability of psychosocial interventions for IBD, this study aims to investigate MBCT as an adjunctive treatment to treatment as usual to reduce psychological stress and improve sleep quality/regularity in patients with IBD who report elevated stress levels. The study will have a follow-up duration of 12 months from baseline.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Interventions for the management of abdominal pain in ulcerative colitis.
Sinopoulou V, Gordon M, Dovey TM, Akobeng AK. · · 2021 · cited 23× · PMID 34291816 · DOI 10.1002/14651858.cd013589.pub2 -
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).
Ter Avest MM, van Velthoven ASM, Speckens AEM, Dijkstra G, et al · · 2023 · cited 6× · PMID 37337261 · DOI 10.1186/s40359-023-01127-0 -
Psychological interventions for treatment of inflammatory bowel disease.
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, et al · · 2025 · cited 5× · PMID 40243391 · DOI 10.1002/14651858.cd006913.pub3 -
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).
Ter Avest MM, Huijbers MJ, Horjus CS, Römkens TEH, et al · · 2025 · cited 3× · PMID 40658641 · DOI 10.1093/ibd/izaf116 -
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)
Avest MMt, Velthoven ASMv, Speckens AEM, Dijkstra G, et al · · 2023 · DOI 10.21203/rs.3.rs-2572155/v1
Verify or expand the search:
- PubMed search for NCT04646785
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Radboud University Medical Center trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04646785 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
- Last refreshed: 24 January 2024
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