Mindfulness-based Cognitive Therapy for Patients With Inflammatory Bowel Disease

NCT04646785 | Completed

• 1 other identifier: MBCT-IBD-2020-2024
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases

Keywords

randomized controlled trial; mindfulness-based cognitive therapy; effectiveness; psychological distress; sleep; fatigue

Outcome Measures

Primary Outcomes (2)

• Psychological distress

  Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, 7 related to depression and 7 related to anxiety. Scoring for each item ranges from zero to three. Three denotes highest anxiety or depression level meaning that a person can score between 0 and 21 for either anxiety or depression.

  Change between baseline and 3 months

• Psychological distress

  Measured by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, 7 related to depression and 7 related to anxiety. Scoring for each item ranges from zero to three. Three denotes highest anxiety or depression level meaning that a person can score between 0 and 21 for either anxiety or depression.

  Change between 3 and 12 months

Secondary Outcomes (26)

• Objective sleep quality

  Change between baseline and 3 months

• Objective sleep quality

  Change between 3 and 12 months

• Subjective sleep quality

  Change between baseline and 3 months

• Subjective sleep quality

  Change between 3 and 12 months

• Fatigue

  Change between baseline and 3 months

Study Arms (2)

Mindfulness-based cognitive therapy (MBCT) added to treatment as usual

EXPERIMENTAL

Patients in the MBCT arm will in addition to their treatment as usual be invited to participate in MBCT.

Behavioral: Mindfulness-based cognitive therapy + TAU

Treatment as usual (TAU)

ACTIVE COMPARATOR

Patients in this arm will receive treatment as usual.

Other: Treatment as usual (TAU)

Interventions

Mindfulness-based cognitive therapy + TAU BEHAVIORAL

The proposed intervention is mindfulness-based cognitive therapy (MBCT), based on the protocol published by Segal, Williams and Teasdale. MBCT consists of eight weekly 2.5h group sessions, a six-hour silent day and daily home practice assignments guided by audio files. The program includes both formal and informal meditation exercises. Cognitive techniques include monitoring and scheduling of activities, identification of negative automatic thoughts and devising a relapse prevention plan. Psycho-education and interactive dialogue typically focus on stress management, balancing activities, and (lifestyle) strategies to stay well in the future (relapse prevention).

Mindfulness-based cognitive therapy (MBCT) added to treatment as usual

Treatment as usual (TAU) OTHER

Treatment as usual (TAU) according Dutch and European IBD treatment guidelines. TAU focuses on pharmacological and surgical disease control, and prevention of complications.

Treatment as usual (TAU)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed IBD diagnosis of Crohn's disease (CD), Ulcerative colitis (UC) or Indeterminate colitis (IC)
• Current IBD remission (Calprotectin \< 250 mg/kg) since at least three months
• Hospital Anxiety and Depression Scale-score of \>=11, indicating at least mild levels of psychological distress (Vodermaier 2011).
• Age of 16 or older
• Taking no IBD medication or on a stable dose of 5-ASA products, immunosuppressive medication, or biologics for at least three months prior to enrollment.

You may not qualify if:

• Severe psychiatric disorders (e.g. acute suicidality, psychosis)
• Current alcohol or drug dependency
• Untreated anemia
• Prior participation in an 8-week MBSR or MBCT-programme

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Jeroen Bosch Ziekenhuis: collaborator
• Rijnstate Hospital: collaborator
• Canisius-Wilhelmina Hospital: collaborator
• Donders Centre for Cognitive Neuroimaging: collaborator

Study Sites (4)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6525 GC, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Related Publications (18)

• Ewais T, Begun J, Kenny M, Rickett K, Hay K, Ajilchi B, Kisely S. A systematic review and meta-analysis of mindfulness based interventions and yoga in inflammatory bowel disease. J Psychosom Res. 2019 Jan;116:44-53. doi: 10.1016/j.jpsychores.2018.11.010. Epub 2018 Nov 14.

  PMID: 30654993 BACKGROUND

• Neuendorf R, Harding A, Stello N, Hanes D, Wahbeh H. Depression and anxiety in patients with Inflammatory Bowel Disease: A systematic review. J Psychosom Res. 2016 Aug;87:70-80. doi: 10.1016/j.jpsychores.2016.06.001. Epub 2016 Jun 6.

  PMID: 27411754 BACKGROUND

• Knowles SR, Graff LA, Wilding H, Hewitt C, Keefer L, Mikocka-Walus A. Quality of Life in Inflammatory Bowel Disease: A Systematic Review and Meta-analyses-Part I. Inflamm Bowel Dis. 2018 Mar 19;24(4):742-751. doi: 10.1093/ibd/izx100.

  PMID: 29562277 BACKGROUND

• IsHak WW, Pan D, Steiner AJ, Feldman E, Mann A, Mirocha J, Danovitch I, Melmed GY. Patient-Reported Outcomes of Quality of Life, Functioning, and GI/Psychiatric Symptom Severity in Patients with Inflammatory Bowel Disease (IBD). Inflamm Bowel Dis. 2017 May;23(5):798-803. doi: 10.1097/MIB.0000000000001060.

  PMID: 28301432 BACKGROUND

• Chavarria C, Casanova MJ, Chaparro M, Barreiro-de Acosta M, Ezquiaga E, Bujanda L, Rivero M, Arguelles-Arias F, Martin-Arranz MD, Martinez-Montiel MP, Valls M, Ferreiro-Iglesias R, Llao J, Moraleja-Yudego I, Casellas F, Antolin-Melero B, Cortes X, Plaza R, Pineda JR, Navarro-Llavat M, Garcia-Lopez S, Robledo-Andres P, Marin-Jimenez I, Garcia-Sanchez V, Merino O, Algaba A, Arribas-Lopez MR, Banales JM, Castro B, Castro-Laria L, Honrubia R, Almela P, Gisbert JP. Prevalence and Factors Associated With Fatigue in Patients With Inflammatory Bowel Disease: A Multicentre Study. J Crohns Colitis. 2019 Aug 14;13(8):996-1002. doi: 10.1093/ecco-jcc/jjz024.

  PMID: 30721954 BACKGROUND

• van der Valk ME, Mangen MJ, Leenders M, Dijkstra G, van Bodegraven AA, Fidder HH, de Jong DJ, Pierik M, van der Woude CJ, Romberg-Camps MJ, Clemens CH, Jansen JM, Mahmmod N, van de Meeberg PC, van der Meulen-de Jong AE, Ponsioen CY, Bolwerk CJ, Vermeijden JR, Siersema PD, van Oijen MG, Oldenburg B; COIN study group and the Dutch Initiative on Crohn and Colitis. Healthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNFalpha therapy: results from the COIN study. Gut. 2014 Jan;63(1):72-9. doi: 10.1136/gutjnl-2012-303376. Epub 2012 Nov 7.

  PMID: 23135759 BACKGROUND

• Burisch J, Jess T, Martinato M, Lakatos PL; ECCO -EpiCom. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013 May;7(4):322-37. doi: 10.1016/j.crohns.2013.01.010. Epub 2013 Feb 8.

  PMID: 23395397 BACKGROUND

• Qazi T, Farraye FA. Sleep and Inflammatory Bowel Disease: An Important Bi-Directional Relationship. Inflamm Bowel Dis. 2019 Apr 11;25(5):843-852. doi: 10.1093/ibd/izy334.

  PMID: 30388243 BACKGROUND

• Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2013). Mindfulness-based cognitive therapy for depression (second).

  BACKGROUND

• Guo J, Wang H, Luo J, Guo Y, Xie Y, Lei B, Wiley J, Whittemore R. Factors influencing the effect of mindfulness-based interventions on diabetes distress: a meta-analysis. BMJ Open Diabetes Res Care. 2019 Dec 11;7(1):e000757. doi: 10.1136/bmjdrc-2019-000757. eCollection 2019.

  PMID: 31908794 BACKGROUND

• Cillessen L, Johannsen M, Speckens AEM, Zachariae R. Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized controlled trials. Psychooncology. 2019 Dec;28(12):2257-2269. doi: 10.1002/pon.5214. Epub 2019 Sep 11.

  PMID: 31464026 BACKGROUND

• Scott-Sheldon LAJ, Gathright EC, Donahue ML, Balletto B, Feulner MM, DeCosta J, Cruess DG, Wing RR, Carey MP, Salmoirago-Blotcher E. Mindfulness-Based Interventions for Adults with Cardiovascular Disease: A Systematic Review and Meta-Analysis. Ann Behav Med. 2020 Jan 1;54(1):67-73. doi: 10.1093/abm/kaz020.

  PMID: 31167026 BACKGROUND

• Zhou B, Wang G, Hong Y, Xu S, Wang J, Yu H, Liu Y, Yu L. Mindfulness interventions for rheumatoid arthritis: A systematic review and meta-analysis. Complement Ther Clin Pract. 2020 May;39:101088. doi: 10.1016/j.ctcp.2020.101088. Epub 2020 Jan 11.

  PMID: 31957665 BACKGROUND

• Haugmark T, Hagen KB, Smedslund G, Zangi HA. Mindfulness- and acceptance-based interventions for patients with fibromyalgia - A systematic review and meta-analyses. PLoS One. 2019 Sep 3;14(9):e0221897. doi: 10.1371/journal.pone.0221897. eCollection 2019.

  PMID: 31479478 BACKGROUND

• Crane RS, Eames C, Kuyken W, Hastings RP, Williams JM, Bartley T, Evans A, Silverton S, Soulsby JG, Surawy C. Development and validation of the mindfulness-based interventions - teaching assessment criteria (MBI:TAC). Assessment. 2013 Dec;20(6):681-8. doi: 10.1177/1073191113490790. Epub 2013 Jun 21.

  PMID: 23794181 BACKGROUND

• Ter Avest MM, Huijbers MJ, Horjus CS, Romkens TEH, Witteman EM, van Dop WA, Dresler M, Donders ART, Dijkstra G, Nissen LHC, Speckens AEM. 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). Inflamm Bowel Dis. 2025 Nov 1;31(11):3021-3032. doi: 10.1093/ibd/izaf116.

  PMID: 40658641 DERIVED

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

• Ter Avest MM, van Velthoven ASM, Speckens AEM, Dijkstra G, Dresler M, Horjus CS, Romkens TEH, Witteman EM, van Dop WA, Bredero QM, Nissen LHC, Huijbers MJ. 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). BMC Psychol. 2023 Jun 19;11(1):183. doi: 10.1186/s40359-023-01127-0.

  PMID: 37337261 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Fatigue

Interventions

Mindfulness-Based Cognitive Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anne Speckens, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Loes Nissen, Dr.

  Jeroen Bosch Ziekenhuis

  STUDY CHAIR

• Marloes Huijbers, Dr.

  Radboud University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Director of Radboudumc Centre for Mindfulness

Model Details: A randomized, multicenter, clinical trial with assessments at baseline, post treatment (3 months later) and follow-ups at 6, 9 and 12 months after baseline.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 30, 2020
• Study Start: August 1, 2021
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: we expect the final report of the primary endpoint of the study December 2024, and we will have an embargo period of 6 months after publication.
• Access Criteria: We will use restricted access, such that interested researchers are welcome to contact us with requests for data. The project team will review the quality of the request and grant permission if the request is in accordance with the terms of use drafted by the Radboudumc.

Locations

NL (4)