Evidence map›Paper›PMID 37337261›Full record

ArticleBMC psychology2023

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 and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC psychology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04646785 (Mindfulness-based Cognitive Therapy to Improve Stress and Sleep in Patients With Inflammatory Bowel Disease), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04646785 nacompletednot on this map

Mindfulness-based Cognitive Therapy to Improve Stress and Sleep in Patients With Inflammatory Bowel Disease

TypeinterventionalSponsorRadboud University Medical CenterRan2021 to 2023Enrolled142ConditionsInflammatory Bowel DiseasesArmsMindfulness-based cognitive therapy + TAU, Treatment as usual (TAU)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Milou M Ter Avest *Department of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Postbus 9101, Nijmegen, 6500 HB, the Netherlands. milou.teravest@radboudumc.nl.
Annelieke S M van Velthoven *Department of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Postbus 9101, Nijmegen, 6500 HB, the Netherlands.
Anne E M SpeckensDepartment of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Postbus 9101, Nijmegen, 6500 HB, the Netherlands.
Gerard DijkstraDepartment of Gastroenterology and Hepatology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.
Martin DreslerDonders Centre for Medical Neuroscience, Donders institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, Nijmegen, the Netherlands.
Carmen S HorjusDepartment of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, the Netherlands.
Tessa E H RömkensDepartment of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.
Ellen M WittemanDepartment of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.
Willemijn A van DopDepartment of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, the Netherlands.
Quirine M BrederoDepartment of Health Psychology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.
Loes H C NissenDepartment of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.
Marloes J HuijbersDepartment of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Postbus 9101, Nijmegen, 6500 HB, the Netherlands.

Funding

ZonMw 555003201
6 · The paper itself

Abstract

backgroundMany 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.

methodsThe 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. DISCUSSION: 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.

trial registrationClinicalTrials.gov: NCT04646785, registered on 30/11/2020.

Indexed as

Cognitive Behavioral TherapyInflammatory Bowel DiseasesMindfulnessPsychological DistressHumansMulticenter Studies as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicSleepTreatment Outcome(Cost-)effectivenessCrohn’s diseaseInflammatory Bowel DiseaseMindfulnessMindfulness-Based Cognitive TherapyPsychological distressRandomised controlled trialSleep qualityStudy protocolUlcerative colitis

Identifiers

PMID37337261
PMCPMC10278305

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.