Evidence map›Paper›PMID 25934170›Full record

Trial reportBMC gastroenterology2015

Cognitive-behavioural therapy has no effect on disease activity but improves quality of life in subgroups of patients with inflammatory bowel disease: a pilot randomised controlled trial.

Antonina Mikocka-Walus, Peter Bampton, David Hetzel, Patrick Hughes, Adrian Esterman, Jane M Andrews

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04861597 (Digital Behavioral Interventions in Inflammatory Bowel Disease), which is not on this map. Cited by 31 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 7 pooled it
6.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04861597 nacompletednot on this mapstarted 2021, after this paper: background citation

Digital Behavioral Interventions in Inflammatory Bowel Disease

TypeinterventionalSponsorMontefiore Medical CenterRan2021 to 2023Enrolled30ConditionsCrohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases, Stress, PsychologicalArmsInternet based cognitive behavioral therapy, Digital mood tracking
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 7 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Psychological interventions for treatment of inflammatory bowel disease.The Cochrane database of systematic reviews · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 2 countries.

Antonina Mikocka-WalusSchool of Nursing and Midwifery and Sansom Institute for Health Research, University of South Australia, Adelaide, Australia. antonina.mikocka-walus@york.ac.uk.
Peter BamptonSchool of Medicine, Flinders University, Adelaide, Australia. peter.bampton@flinders.edu.au.
David HetzelDepartment of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia. djhetzel@ozemail.com.au.
Patrick HughesNerve-Gut Research Laboratory, Discipline of Medicine, University of Adelaide, Adelaide, Australia. patrick.hughes@adelaide.edu.au.
Adrian EstermanSchool of Nursing and Midwifery and Sansom Institute for Health Research, University of South Australia, Adelaide, Australia. adrian.esterman@unisa.edu.au.
Jane M AndrewsSchool of Medicine, Flinders University, Adelaide, Australia. jane.andrews@health.sa.gov.au.
Royal Adelaide Hospital · AUFlinders University · AUUniversity of Adelaide · AUUniversity of South Australia · AUUniversity of York · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStudies have demonstrated usefulness of cognitive-behavioural therapy (CBT) in managing distress in inflammatory bowel disease (IBD); however, few have focused on IBD course. The present trial aimed to investigate whether adding CBT to standard treatment prolongs remission in IBD in comparison to standard therapy alone.

methodsA 2-arm parallel pragmatic randomised controlled trial (+CBT - standard care plus either face-to-face (F2F) or online CBT over 10 weeks versus standard care alone (SC)) was conducted with adult patients in remission. IBD remission at 12 months since baseline was the primary outcome measure while the secondary outcome measures were mental health status and quality of life (QoL). Linear mixed-effect models were used to compare groups on outcome variables while controlling for baseline.

resultsParticipants were 174 patients with IBD (90 +CBT, 84 SC). There was no difference in remission rates between groups, with similar numbers flaring at 12 months. Groups did not differ in anxiety, depression or coping at 6 or 12 months (p >0.05). When only participants classified as 'in need' (young, high baseline IBD activity, recently diagnosed; poor mental health) were examined in the post-hoc analysis (n = 74, 34 CBT and 40 controls), CBT significantly improved mental QoL (p = .034, d = .56) at 6 months. Online CBT group had a higher score on Precontemplation than the F2F group, which is consistent with less developed coping with IBD in the cCBT group (p = .045).

conclusionsFuture studies should direct psychological interventions to patients 'in need' and attempt to recruit larger samples to compensate for significant attrition when using online CBT.

trial registrationThe protocol was registered on 21/10/2009 with the Australian New Zealand Clinical Trials Registry (ID: ACTRN12609000913279).

Indexed as

Cognitive Behavioral TherapyHealth StatusMental HealthAdultCombined Modality TherapyFemaleHumansInflammatory Bowel DiseasesLinear ModelsMaleMiddle AgedPilot ProjectsQuality of LifeRemission InductionTreatment Outcome

Identifiers

PMID25934170
PMCPMC4427935
OpenAlexW2000130446

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.