Psychological Intervention for Fatigue in Inflammatory Bowel Diseases

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT06860009
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Crohn's Diseases
  • IBD
  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Multicomponent psychological intervention — BEHAVIORAL
    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.
  • Early start — BEHAVIORAL
    Patients in the early group immediately start with the multicomponent psychological intervention
  • Late start (after 28 weeks) — BEHAVIORAL
    Patients in the late intervention group will wait 28 weeks before starting the intervention

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Mar 2025
Primary completion
Sep 2, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
155 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: Early intervention group
    Group starts immediately with the 14-week intervention
  • Other: Late intervention group
    Group starts with 14-week intervention after 28 weeks

Primary Outcome Measure

FACIT fatigue scale [ Time Frame: 14 weeks ]

Related Studies