TY - JOUR
T1 - Effectiveness of Mindfulness-Based Cognitive Therapy in reducing psychological distress and improving sleep in patients with Inflammatory Bowel Disease
T2 - study protocol for a multicentre randomised controlled trial (MindIBD).
AU - ter Avest, Milou M.
AU - van Velthoven, Annelieke S.M.
AU - Speckens, Anne E.M.
AU - Dijkstra, Gerard
AU - Dresler, Martin
AU - Horjus, Carmen S.
AU - Römkens, Tessa E.H.
AU - Witteman, Ellen M.
AU - van Dop, Willemijn A.
AU - Bredero, Quirine M.
AU - Nissen, Loes H.C.
AU - Huijbers, Marloes J.
N1 - Funding Information:
This study is externally funded by a grant from ZonMw, the Netherlands Organization for Health Research and Development (Grant Number: 555003201) awarded to prof. dr. A.E.M. Speckens, dr. M.J. Huijbers and dr. L.H.C. Nissen. The funding agency will have no role in data design, collection, analysis, interpretation of data or writing the manuscript.
Funding Information:
We would like to thank Margot van ‘t Hof, Menne Scherpenzeel and Daniëlle van der Horst of Crohn & Colitis NL (Dutch IBD patient association), who were involved in the study design and in particular in the wording of the patient information.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - (Cost-)effectiveness
KW - Crohn’s disease
KW - Inflammatory Bowel Disease
KW - Mindfulness
KW - Mindfulness-Based Cognitive Therapy
KW - Psychological distress
KW - Randomised controlled trial
KW - Sleep quality
KW - Study protocol
KW - Ulcerative colitis
U2 - 10.1186/s40359-023-01127-0
DO - 10.1186/s40359-023-01127-0
M3 - Article
C2 - 37337261
AN - SCOPUS:85162259701
SN - 2050-7283
VL - 11
JO - BMC Psychology
JF - BMC Psychology
M1 - 183
ER -