Inflammatory bowel disease Digestive System Inflammatory bowel disease
Conditions
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 gener
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported IBD-fatigue is measured using the Inflammatory Bowel Disease –Fatigue Scale (IBD-F) at baseline, 3, 6 and 12-months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed