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.
BACKGROUND
Studies 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.


METHODS
A 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.


RESULTS
Participants 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).


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


BACKGROUND
The protocol was registered on 21/10/2009 with the Australian New Zealand Clinical Trials Registry (ID: ACTRN12609000913279).
School of Nursing and Midwifery and Sansom Institute for Health Research, University of South Australia, Adelaide, Australia. antonina.mikocka-walus@york.ac.uk.|Department of Health Sciences, University of York, Area 4, ARRC Building, Heslington, YO10 5DD, UK. antonina.mikocka-walus@york.ac.uk.|School of Psychology, University of Adelaide, Adelaide, Australia. antonina.mikocka-walus@york.ac.uk.
Antonina
A
Mikocka-Walus
School of Medicine, Flinders University, Adelaide, Australia. peter.bampton@flinders.edu.au.|Department of Gastroenterology and Hepatology, Flinders Medical Centre, Bedford Park, Australia. peter.bampton@flinders.edu.au.
Peter
P
Bampton
Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia. djhetzel@ozemail.com.au.
David
D
Hetzel
Nerve-Gut Research Laboratory, Discipline of Medicine, University of Adelaide, Adelaide, Australia. patrick.hughes@adelaide.edu.au.
Patrick
P
Hughes
School of Nursing and Midwifery and Sansom Institute for Health Research, University of South Australia, Adelaide, Australia. adrian.esterman@unisa.edu.au.
Adrian
A
Esterman
School of Medicine, Flinders University, Adelaide, Australia. jane.andrews@health.sa.gov.au.|Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia. jane.andrews@health.sa.gov.au.|School of Medicine, University of Adelaide, Adelaide, Australia. jane.andrews@health.sa.gov.au.
Jane M
JM
Andrews
D000328:Adult; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D005260:Female; D006304:Health Status; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000523:psychology / Q000628:therapy*; D016014:Linear Models; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life / Q000523:psychology*; D012074:Remission Induction; D016896:Treatment Outcome