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).

Autor: Ter Avest MM; Department of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Postbus 9101, Nijmegen, 6500 HB, the Netherlands. milou.teravest@radboudumc.nl.; Donders Centre for Medical Neuroscience, Donders institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, Nijmegen, the Netherlands. milou.teravest@radboudumc.nl.; Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands. milou.teravest@radboudumc.nl., van Velthoven ASM; Department of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Postbus 9101, Nijmegen, 6500 HB, the Netherlands.; Donders Centre for Medical Neuroscience, Donders institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, Nijmegen, the Netherlands., Speckens AEM; Department of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Postbus 9101, Nijmegen, 6500 HB, the Netherlands.; Donders Centre for Medical Neuroscience, Donders institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, Nijmegen, the Netherlands., Dijkstra G; Department of Gastroenterology and Hepatology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands., Dresler M; Donders Centre for Medical Neuroscience, Donders institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, Nijmegen, the Netherlands., Horjus CS; Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, the Netherlands., Römkens TEH; Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands., Witteman EM; Department of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands., van Dop WA; Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, the Netherlands., Bredero QM; Department of Health Psychology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands., Nissen LHC; Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands., Huijbers MJ; Department of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Postbus 9101, Nijmegen, 6500 HB, the Netherlands.; Donders Centre for Medical Neuroscience, Donders institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, Nijmegen, the Netherlands.
Jazyk: angličtina
Zdroj: BMC psychology [BMC Psychol] 2023 Jun 19; Vol. 11 (1), pp. 183. Date of Electronic Publication: 2023 Jun 19.
DOI: 10.1186/s40359-023-01127-0
Abstrakt: Background: 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.
Methods: 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.
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 Registration: ClinicalTrials.gov: NCT04646785, registered on 30/11/2020.
(© 2023. The Author(s).)
Databáze: MEDLINE
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