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

INTERVENTION: 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’s and Colitis UK “Fatigue in IBD” Information Sheet to use without therapist help. CC UK is the UK’s 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 include both genders, a range of ages, both IBD diagnoses and those successful and not successful in showing an initial improvement in IBD‐fatigue, to better understand patient perspectives on the intervention. Participants will be asked about the process of recruitment and randomisation, their experience of t CONDITION: Inflammatory bowel disease ; Digestive System ; Inflammatory bowel disease PRIMARY OUTCOME: Self‐reported IBD‐fatigue is measured using the Inflammatory Bowel Disease –Fatigue Scale (IBD‐F) at baseline, 3, 6 and 12‐months post‐randomisation. 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) SECONDARY OUTCOME: Pilot randomised controlled trial:; Self‐reported IBD‐quality of life is measured using the United Kingdom Inflammatory Bowel Disease Questionnaire (UK IBDQ) at baseline, 3, 6 and 12‐months post‐randomisation. ; ; Explanatory variables:; 1. Disease activity is measured using Disease activity indexes, Harvey Bradshaw Index (HBI) and the Simple Clinical Colitis Activity Index (SCCAI) at baseline, 3, 6 and 12‐months post‐randomisation; 2. Illness perceptions are measured using the Brief Illness Perceptions Questionnaire (BIPQ) at baseline and 3‐months post‐randomisation; 3. Daytime sleepiness is measured using the Epworth Sleepiness Scales (ESS) at baseline and 3‐months post‐randomisation; 4. Anxiety is measured using the 7‐item Generalized Anxiety Disorder Scale (GAD7) at baseline and 3‐months post‐randomisation; 5. Depression is measured using the 9‐item Patient Health Questionnaire (PHQ9) at baseline and 3‐months post‐randomisation; ; Nested qualitative study:; Experience and acceptability of the intervention will be evaluated by conducting post‐intervention interviews with a subset of 7 participants from the intervention group.