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NOT YET RECRUITING
NCT06860009
NA

Psychological Intervention for Fatigue in Inflammatory Bowel Diseases

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

The investigators would like to evaluate the effect of a multicomponent psychological treatment on fatigue as a symptom of patients with inflammatory bowel diseases (IBD). The intervention will be a combined program consisting of a psychological intervention (Acceptance and Commitment Therapy) and a behavioral intervention (implementation of frequent short naps and graded increase of physical activity). Next to the hypothesized effect on fatigue, the investigators will also measure the effect on fatigability, IBD related disability, anxiety, depression, stress, disease acceptance and perceived control as well as (biomarkers of) disease activity.

Official title: Psychological Intervention for Fatigue in Inflammatory Bowel Diseases: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

155

Start Date

2025-09-01

Completion Date

2027-10-30

Last Updated

2025-03-10

Healthy Volunteers

No

Interventions

BEHAVIORAL

Multicomponent psychological intervention

The multicomponent intervention starts with 8 sessions of ACT (Acceptance and commitment therapy) once a week. After four weeks, patients start with graded activity and frequent napping. After eight weeks in the intervention period, patients will have consults with an IBD psychologist every two weeks. The intervention period is 14 weeks in total.

BEHAVIORAL

Early start

Patients in the early group immediately start with the multicomponent psychological intervention

BEHAVIORAL

Late start (after 28 weeks)

Patients in the late intervention group will wait 28 weeks before starting the intervention