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).
Study Goal
The researchers aimed to determine whether Mindfulness-Based Cognitive Therapy (MBCT) could reduce psychological distress, improve sleep quality, fatigue, and quality of life in patients with Inflammatory Bowel Diseases (IBD).
Results Summary
The study is ongoing, but it hypothesizes that MBCT will effectively reduce psychological distress and improve sleep, fatigue, and quality of life in IBD patients, with potential broader applicability to other chronic conditions.
Population
IBD patients in remission, aged 16+, with at least mild psychological distress (HADS total score ≥ 11).
Effective Dosage
Not specified
Duration
Assessments at baseline, 3, 6, 9, and 12 months follow-up (intervention duration not explicitly stated).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | decrease | psychological distress, QoL and sleep | patients with IBD | - | might also be effective | #1 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | decrease | psychological distress | IBD patients in remission, aged 16 years and older with at least mild psychological distress | - | primary outcome is reduction | #2 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | increase | sleep quality (including actigraphy and electroencephalography recordings) | IBD patients in remission, aged 16 years and older with at least mild psychological distress | - | effect will be examined | #3 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | decrease | fatigue | IBD patients in remission, aged 16 years and older with at least mild psychological distress | - | effect will be examined | #4 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | decrease | disease activity | IBD patients in remission, aged 16 years and older with at least mild psychological distress | - | effect will be examined | #5 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | increase | perceived disease control | IBD patients in remission, aged 16 years and older with at least mild psychological distress | - | effect will be examined | #6 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | increase | QoL | IBD patients in remission, aged 16 years and older with at least mild psychological distress | - | effect will be examined | #7 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | increase | positive mental health | IBD patients in remission, aged 16 years and older with at least mild psychological distress | - | effect will be examined | #8 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | neutral | psychological distress, sleep quality, fatigue and QoL | IBD patients | - | will provide valuable insight into the clinical effect | #9 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | neutral | cost-effectiveness | IBD patients | - | will provide valuable insight into | #10 |
Mindfulness-Based Cognitive Therapy (MBCT) plus Treatment As Usual (TAU) | neutral | available psychosocial interventions | patients with IBD | - | can be a valuable addition | #11 |
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.