Psychological Intervention for Fatigue in Inflammatory Bowel Diseases

NCT06860009 | Not Yet Recruiting

• 1 other identifier: PEARL
• Study Type: interventional
• Target: 155
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

fatigue; IBD

Outcome Measures

Primary Outcomes (1)

• FACIT fatigue scale

  The percentage of participants achieving a ≥20% improvement on the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (indicating reduced fatigue) between baseline and week 14.

  14 weeks

Study Arms (2)

Early intervention group

OTHER

Group starts immediately with the 14-week intervention

Behavioral: Multicomponent psychological intervention; Behavioral: Early start

Late intervention group

OTHER

Group starts with 14-week intervention after 28 weeks

Behavioral: Multicomponent psychological intervention; Behavioral: Late start (after 28 weeks)

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 intervention group; Late intervention group

Early start BEHAVIORAL

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

Early intervention group

Late start (after 28 weeks) BEHAVIORAL

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

Late intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Males and females 18-70 years old.
• Patients with a diagnosis of ulcerative colitis (UC), Crohn's disease (CD), inflammatory bowel disease type unclassified (IBDU) based on radiology, endoscopy and/or histology
• Patients with a disease duration of more than one year
• Patients with a score of \<30 on the FACIT Fatigue scale
• Patients possessing a smartphone
• Patients with an availability to commit to daily behavioural changes
• Patients being fluent in Dutch.

You may not qualify if:

• Patients that initiated new IBD medication (steroids, mesalamine, thiopurines, methotrexate, biologicals or small molecules) in the past three months prior to screening
• Patients with objective signs of active disease (CRP\<10mg/L or faecal calprotectin \<250µg/g) at screening
• Participation in an interventional Study with an investigational medicinal product (IMP) or device at screening
• Patients with planned surgery at screening
• Patients with an iron (\<65 µg/dL), vitamin D (\<11 µg/L), vitamin B12 (\<197 ng/L) or folic acid (\<3.9 µg/L) deficiency or malnutrition (weight loss \>10-15% within six months, BMI \<18.5 kg/m², NRS \>5 or serum albumin \<30 g/L) at screening
• Patients with thyroid dysfunction or hypophosphatemia at screening
• Patients with physical injury (according to researcher's interpretation) at screening
• Patients with self-reported sleep disturbance or periods of apnoea at screening
• Patients with BMI \>30 kg/m² at screening
• Patients with present or past diagnosis of severe psychiatric disease diagnosis (ongoing major depression, schizophrenia, bipolar disease, ongoing substance abuse) at screening
• Patients that initiated new psychotropic medication or had a changed dosage of psychotropic medication in the past three months prior to screening

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Colitis, Ulcerative; Fatigue

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in early or late intervention group. The early intervention group immediately start with the intervention, while the late intervention group will wait until week 28 to start with the 14 week intervention.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 2, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: March 10, 2025

Record last verified: 2025-03