Skip to main content
. 2021 Nov 29;2021(11):CD013531. doi: 10.1002/14651858.CD013531.pub2

Berrill 2014.

Study characteristics
Methods RCT
Setting: multicentre, hospitals in the UK
Study period: February 2011 to May 2012
The study presents results for the IBD cohort as a whole, does not separate between CD and UC. Where separate data do exist they are presented below.
Participants Inclusion criteria: age 18 to 65 years, diagnosis of UC or CD that was in remission based on a clinical index score and a C‐reactive protein level < 10 mg/L, and the presence of IBS‐type symptoms or a high perceived stress level
Exclusion criteria: pregnancy, the presence of ileostomy or colostomy, previous colectomy, change in IBD medication (including use of steroids) within 3 months of study entry, change in psychotropic medication within 3 months of study entry, diagnosis of cognitive impairment, and previous psychological therapy
Age (mean ± SD): IG: 44.4 +/‐ 11.7; CG: 45.4 +/‐ 10.6
Sex (M/F): IG: 8/25; CG: 7/26
Site of disease:
CD:
  • IG: ileal 2; ileo‐colonic 3; colonic 4

  • CG: ileal 4; ileo‐colonic 4; colonic 4


UC:
  • IG: proctitis 6; left‐sided 14; pan‐colitis 4

  • CG: proctitis 5; left‐sided 14; pan‐colitis 2


Use of concurrent medication:
IG: 5‐ASA 23; immunosuppressants 8; biologics 3
CG: 5‐ASA 22; immunosuppressants 13; biologics 0
Disease duration: NS
Disease activity: remission. Clinical remission was assessed using SCCAI for UC and HBI for CD. Biochemical remission was assessed based on faecal calprotectin levels.
Number randomised:
IG: 33; CG: 33 (UC = 45, CD = 21)
Number reaching end of study:
IG: 16; CG: 28
Number analysed:
ITT IG: 23; ITT CG: 28
PP IG: 16; PP CG: 30
Postrandomisation exclusion:
IG: 14; CG: 1
Interventions IG: multi‐convergent therapy combining mindfulness with cognitive behavioural therapy. The multi‐convergent therapy course consisted of 6 face‐to‐face sessions, each lasting 40 min, taking place over a 16‐week period.
CG: no treatment
Both groups received standard medical treatment throughout.
Outcomes Length of intervention: 12 months
Primary outcomes:
Pain frequency and intensity: Improvement on the IBS‐SSS, which includes frequency and severity of abdominal discomfort, severity of abdominal bloating, satisfaction with bowel habit, and impact of symptoms on life in general. Each domain is scored 0 to 100, with an overall score of 0 to 500 obtained. A higher score is indicative of more severe symptoms.
Withdrawal due to adverse events
Secondary outcomes:
Anxiety/depression: measured on the HADS
 
Notes Funding source: National Institute for Social Care and Health Research (NISCHR)
Conflict of interest: Authors declare there are no conflicts of interest.
Author contact details: jamesberrill1@doctors.org.uk
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A blocked randomisation process using random permuted blocks of sizes 4 and 6 (selected at random) was generated by the South East Wales Trials Unit.
Allocation concealment (selection bias) Low risk The sequences were put into sequentially numbered, sealed, opaque envelopes for use in the clinic.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No mention of who performed the assessments or if they were blinded. We contacted the author for this information but received no response.
Incomplete outcome data (attrition bias)
All outcomes High risk High number of participants in the IG discontinued the study.
Selective reporting (reporting bias) Unclear risk Primary outcome is reported on, but most outcomes outlined in the methods were not presented in the results. We contacted the authors but received no response.
Other bias Low risk No conflicts of interest and well‐balanced baseline characteristics, despite age differences