O' Connor 2019.

Methods	A single‐centred randomised, placebo‐controlled, open trial
Participants	40 adults (aged 18 years and older) with IBD (20 adults with Crohn's disease and 20 adults with ulcerative colitis) in clinical and biochemical remission with no other obvious identifiable explanation for their fatigue. Remission for CD will be defined as HBI < 5 and CRP < 5. For UC, it will be defined as partial Mayo score ≤ 2 and CRP < 5. For both groups a faecal calprotectin (FC) of > 250 ug/g will be regarded as indicating active disease and will exclude participants from the study. Participants will also be excluded if they are anaemic (Hb < 14g/dL for males, 11.5g/dL for females). In the CD arm, participants will be assessed for Vitamin B12 and Vitamin D status and excluded if B12 is less than 300 pmol/L or Vitamin D less than 30 ng/mL.
Interventions	Experimental: Structured psychoeducational intervention centred around a self‐management booklet and group work (3 small group sessions over 6 months) Comparator: Standard care
Outcomes	Primary outcome: Fatigue severity and impact (CCUK fatigue score at 20 weeks) Secondary outcomes: Anxiety/depression (HADS at 20 weeks) Somatisation (PHQ15 at 20 weeks) IBS symptoms (Rome III at 20 weeks) Quality of life (SIBDQ and SF‐36 at 20 weeks) Disease activity (HBI/Mayo score; CRP and FC) Activity diaries (for four weeks) Fatigue scores and disease activity (as measured by HBI/Mayo score, CRP, FC), quality of life (as measured by SF‐36 & SIBDQ), anxiety and depression (HAD) or somatisation (PHQ15)
Notes	Estimated enrollment: 40 participants Small pilot RCT recently published