1. To investigate the efficacy of MBCT on reducing fatigue 2. To investigate the efficacy of MBCT on reducing fatigue interference and anxiety and depression and improving IBD-specific quality of life, sleep quality, and labor participation, and to…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is fatigue as assessed by the Checklist Individual
Strength.
Secondary outcome
Secondary outcomes are: fatigue interference, anxiety, severity of depressive
symptoms, IBD-specific quality of life, sleep quality, labor participation,
satisfaction,
Additional several mediators, predictors to assess the effectivness of the
interventions, demographic & clinical characteristics, treatment adherence by
therapist and patients and non-study interventions will be assessed.
Background summary
Fatigue is highly prevalent among patients with IBD. MBCT is an evidence-based
psychological treatment for reducing fatigue in patients with other chronic
illnesses, but its effectiveness for patients with IBD needs more evidence.
This longitudinal study aims to investigate the effectiveness of MBCT in
reducing fatigue in IBD patients who are fatigued. Potential moderators and
mediators of interventions will be examined.
Study objective
1. To investigate the efficacy of MBCT on reducing fatigue
2. To investigate the efficacy of MBCT on reducing fatigue interference and
anxiety and depression and improving IBD-specific quality of life, sleep
quality, and labor participation, and to evaluate the benefits of the
interventions from a patient perspective.
3. To investigate whether an increase in mindfulness and self-compassion, and a
reduction in rumination, is associated with a reduction in fatigue
4. To investigate which IBD patients are more likely to respond positively to
MBCT
Study design
The study is a multicenter two-arm RCT, with patients randomly assigned to MBCT
or a waiting list control condition. As all patients in the current study are
screened and have elevated levels of fatigue, all patients will be offered
psychological treatment, either directly or three months after inclusion.
Intervention
A manualized intervention protocol including a detailed description of the
content and homework assignments of each session has been developed (see
Appendix I). MBCT is a highly structured intervention, that is internationally
offered using a fixed program and week-to-week agenda, and is delivered in
group form. The intervention consists of eight weekly sessions of 150 minutes
led by experienced mindfulness trainers (licensed) who will be trained and
supervised by dr. M. Schroevers. The first sessions focus on enhancing
present-moment awareness of physical sensations, thoughts, emotions, and
behavioral impulses and awareness of pleasant and unpleasant events. In the
latter sessions, there is a greater focus on using mindfulness in dealing
differently with distressing thoughts and emotions. For the proposed study, the
protocol will have some adjustments to make them fatigue and IBD-specific, i.e.
by adding IBD-specific and fatigue psycho-education. Patients receive a
workbook with homework assignments and are expected to spend 30 minutes per day
on these assignments. Patients will also receive audio CDs with mindfulness
exercises.
Study burden and risks
The burden for patients consists of completing a questionnaire at four (MBCT
group) or five (control group) points in time (time costs, 30 minutes each
time). Patients receive treatment that has proven to be effective in the
treatment of fatigue. Time costs: 8 weekly sessions of 150 minutes each and
about 30 minutes of daily homework. We know of no negative effects of this
treatment. Therefore, we consider the risks of this study to be low.
A. Deusinglaan 1
Groningen 9713 AV
NL
A. Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
-Diagnosed with either Crohn*s disease or Ulcerative Colitis by a gastroenterologist
-Currently in remission, as defined by a score of < 4.99 on the mHealth Index Colitis Ulcerosa or a score of < 6.38 on the mHealth Index Crohn
-No expectation of a surgery in the upcoming three months
-Score on subjective fatigue subscale CIS (8 items) * 27
-Age * 18 and * 75 years at the time of study entrance
-Being able to attend eight weekly group sessions of 2,5 hours in the hospital
-Being able to read, write, and speak Dutch
-Written informed consent.
Exclusion criteria
- Severe cognitive, neurological or psychiatric co-morbidity that could interfere with patients* participation and/or warrant other treatment, including acute suicidal ideations or behavior, diagnosis of schizophrenia or history of psychotic complaints, bipolar disorder, severe personality disorder, or history of clinically significant drug abuse or substance dependence
- Pregnancy
- Anemia
- Change in IBD medication (including use of steroids) within 1 month before study entry.
- Currently receiving psychological treatment for fatigue or for psychological/psychiatric problems
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58092.042.16 |