MODIFY Fatigue: a cognitive-behavioral therapy intervention study to improve fatigue in inflammatory bowel disease patients

Not Applicable

Completed

• Conditions: Inflammatory bowel disease; Digestive System

• Registration Number: ISRCTN17917944
• Lead Sponsor: King's College London

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31890258 (added 02/01/2020) 2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28490349

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-06
• Study Completion: 2018-08-08
• Last Update Posted: 21 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1. Patients who are currently experiencing fatigue
2. Proof of diagnosis of IBD (record of diagnostic endoscopy in patient clinical notes); patients without this test will not be included
3. Aged 18 year old and over
4. No current flare-ups of disease (experiencing usual bowel symptoms when disease not in active flare)

Exclusion Criteria

1. Current flare-up of disease (experiencing bowel symptoms usually associated with active flare)
2. Course of CBT for any reason in the last year
3. Currently enrolled in another trial involving a novel pharmacological intervention
4. Current or planned pregnancy
5. Inability to give informed consent (for example, due to reduced mental capacity)
6. Insufficient command of written and spoken English to understand study documents or procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported IBD-fatigue is measured using the Inflammatory Bowel Disease –Fatigue Scale (IBD-F) at baseline, 3, 6 and 12-months post-randomisation.