Trial Details

Not Recruiting
Basic Information
Clinical ID c2911
Identifier ISRCTN17917944
Trial Title Management of inflammatory bowel disease-fatigue: a pilot cognitive-behavioural therapy interventional study
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Inflammatory bowel disease Digestive System Inflammatory bowel disease
Interventions Pilot randomised controlled trial: Consenting participants will be randomised to CBT manual plus therapist support or Fatigue Information Sheet only using an online random number generator with a 1:1 ratio. All baseline information will be collected prior to randomisation. Participants will be randomised at the individual level. Owning to the nature of the study the participants, the researchers and the therapist will not be blinded to treatment allocation after randomisation. Arm 1: Participants will receive a CBT manual for the management of fatigue and have one 60-minute session and seven 30-minute telephone/Skype sessions with a therapist over an eight week period. All sessions will be over the telephone or Skype according to patient preference. During the intervention participants will have access to all usual care, including the nurse-led helpline. Arm 2: Participants will receive the Crohn and Colitis UK fatigue in IBD Information Sheet to use without therapist help. CC UK is the UK leading charity for patients with CD and UC. CC UK provides patients with free online information sheet and guides to help those affected by IBD. All participants will complete outcome measures at 3, 6 and 12-months follow-up. At 12 months, participants in Group 2 (Fatigue Information Sheet) will be provided with the CBT manual received by Group 1 if they wish. They will not receive any therapist support with the manual. Nested qualitative study: A subset of participants from the RCT will be invited for qualitative interviews (n = 7), after they have completed the 3-month post-randomisation outcome measures. This interview sub-sample will be purposely sampled to
Participant Information
Sponsor King's College London
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2018-08-08