Journal of Psychosomatic Research 68 (2010) 385 388
Predictors of treatment outcome after cognitive behavior therapy and
antispasmodic treatment for patients with irritable bowel syndrome
in primary care
Silje Endresen Reme, Tom Kennedy, Roger Jones, Simon Darnley, Trudie Chalder
Department of Psychological Medicine, King's College London, UK
Received 12 October 2009; received in revised form 17 December 2009; accepted 5 January 2010
Abstract
Objective: To examine predictors of treatment outcome in IBS-
patients who participated in a randomized controlled trial in
primary care, where 149 irritable bowel syndrome (IBS) patients
were randomized to mebeverine hydrochloride (n=77) or mebe-
verine+cognitive behavior therapy (CBT) (n=72). CBT offered
additional benefit over mebeverine alone. Methods: Regression
analyses were used to identify predictors of work and social
adjustment 12 months after treatment ended. The intervention
groups were analyzed separately in order to look at the separate
effects in each group. Results: Lower levels of psychological
distress (anxiety and depression) at baseline predicted a good
Keywords: Cognitive behavior therapy; Irritable bowel syndrome; Primary care; Predictors of treatment outcome; Clinical implications
Introduction
Few studies have looked specifically at predictors of
treatment outcome after cognitive-behavioral treatments
(CBT) for irritable bowel syndrome (IBS). Those who
have find psychological disturbance to be an important
predictor of a poor outcome. Less baseline anxiety predicted
a better outcome in one study [1], whereas others have found
a lower likelihood of success with the presence of one or
more psychiatric disorders [2,3] and baseline depression [4].
Although psychological distress overall seems to predict a
poor outcome in CBT treatments, studies from other
Corresponding author. Research Centre for Health Promotion, Faculty
of Psychology, University of Bergen, Christies gt 13, 5015 Bergen, Norway.
Tel.: +47 55583991; fax: +47 55 58 98 78.
E-mail address: silje.reme@uib.no (S.E. Reme).
0022-3999/10/$ see front matter 2010 Elsevier Inc. All rights reserved.
doi:10.1016/j.jpsychores.2010.01.003
outcome in the mebeverine group [=0.388 (95% CI: 0.065
0.936), P=.025] but not in the mebeverine+CBT group. In the
adjusted model for the mebeverine+CBT group less adaptive IBS
related behavioral coping predicted a good outcome [=0.285
(95% CI: 0.0020.210), P=.045]. Conclusion: Different factors
are associated with outcome depending on the treatment
received. At assessment clinicians should assess patients coping
styles and may want to consider recommending CBT to those
patients with IBS in primary care who are engaging in unhelpful
coping behavior.
2010 Elsevier Inc. All rights reserved.
psychological treatments reveal results that point in the
opposite direction [5,6].
Symptom characteristics also show some inconsistencies
in the literature, in that severity of gastrointestinal symptoms
predicted a poor outcome in one study [1] and a good
outcome in another [7]. Conflicting results may reflect the
different measures of outcome or criterion used, the
intervention received, or lack of statistical power due to
few participants in the studies.
In a recent randomized controlled trial (RCT) from
primary care where CBT was added to antispasmodic
treatment (mebeverine), we found that CBT offered addi-
tional effects over mebeverine alone [8]. CBT might therefore
be useful to certain IBS patients in primary care. In order to
find out who may benefit from which treatment, predictors of
treatment outcome need to be identified. This article reports
on predictors of treatment outcome through a secondary
analysis of the aforementioned RCT in primary care. We
386 S.E. Reme et al. / Journal of Psychosomatic Research 68 (2010) 385388
chose predictors which represented the multidimensional
nature of the disorder and included measures of distress,
unhelpful perceptions/cognitions, and behavioral coping.
Based on previous findings, we hypothesized that psycho-
logical distress (anxiety and depression) would predict a poor
treatment outcome at 12 months of follow-up for both groups.
Method
Patients diagnosed with IBS aged 1650 years were
recruited from 10 general practices in London. Three hundred
thirty-four patients were referred to the study; 235 consented
to participate, and those still symptomatic (moderate to severe
IBS symptoms) after 2 weeks of general practitioner care and
4 weeks of mebeverine hydrochloride (275 mg 3 times a day)
were included in the trial (n=149). Of those consenting to
participate, 52 were no longer symptomatic at the time of
inclusion, while 34 dropped out [8]. Participants were
randomized to receive six sessions of CBT in addition to
mebeverine (72 patients) or continue with mebeverine alone
(77 patients). Four general practice nurses delivered the CBT.
All participants were asked to complete a series of
questionnaires. Of these, the following were hypothesized to
predict treatment outcome: psychological distress (anxiety
and depression combined score) [9,10], illness perceptions
(IPQs) [11], IBS symptoms [12], cognitions about IBS [13],
and IBS-related coping behavior. The latter is a new
questionnaire designed and validated by the researchers. It
allows assessment of changes in specific coping behaviors
used by patients with IBS and includes items related to
avoidance behavior and toileting behavior. It was found to be
both valid and reliable (Cronbach's =.89) [14]. The primary
outcome for the prediction analyses was the work and social
adjustment (WASA) scale at 12 months of follow-up which
measures ability to work, manage the home, and participate
in social and private leisure activities and relationships. The
scale ranges from 0 to 40, with higher scores indicating more
disability [15].
Ethical approval was received from St. Thomas' Hospital
Research Ethics Committee; Guy's Hospital Research Ethics
Committee; and Barnet, Enfield, and Haringey LREC.
Statistical analyses
All analyses were performed using SPSS version 15. The
participants filled out questionnaires 3, 6, 9, and 12 months
Table 1
Unadjusted models for each treatment group separately; only significant (Pb.01) predictors included
Outcome: work and social adjustment 12 months
Predictor variables
Work and social adjustment (higher score=more disability)
Psychological distress (anxiety and depression) (higher score=more distress)
Behavioral Scale (higher score=more adaptive behavior)
IPQ consequences (higher score=worse consequences)
after treatment ended. IBS tends to be a chronic condition
and the 12-month follow-up was therefore chosen as the
outcome in this study. WASA was a secondary outcome in
the trial but was chosen as the main outcome of this study
since health status and functionality can be argued to be
more important than symptom severity and because the
difference between the treatment groups were still detect-
able on WASA at 12 months. Both outcome and predictor
variables were continuous, and the association between
them was assumed to be linear. Multiple linear regression
analyses were therefore chosen. Unadjusted and adjusted
analyses were used to assess the strength of relationships
between hypothesized predictors and outcome. All models
were stratified by intervention group and examined
separately in order to assess determinants of outcome for
each treatment. Statistically significant predictors (Pb.01)
from the unadjusted analyses were included in an adjusted
regression model.
Results
In the previous study, the addition of CBT to mebeverine
produced a significant benefit compared with the
mebeverine-only group on symptom severity and WASA.
The difference on the WASA scale represented therapeutic
gains of approximately 20% and 40%, respectively. The
improvements began to wane over time, and by 12 months
of follow-up, significant therapeutic benefit of the addition
of CBT could only be detected on the WASA scale. Full
details of main findings and response rates are reported
elsewhere [8]. Most patients were women (85%), mean age
was 33.8 years (S.D. 9.1), and the majority were Caucasian
British (69%); 50% had experienced IBS for more than
5 years, and 52% reported psychological problems during
the last 5 years.
Follow-up data on the WASA scale at 12 months were
available from 73% of the participants, 71% in the
mebeverine+CBT group (n=51) and 75% in the mebeverine
group (n=58).
The results from the unadjusted analyses showed that
baseline WASA scores, psychological distress (anxiety and
depression), IBS-coping behavior, and a belief that the IBS
would have serious consequences for the patient's life, health
and well-being (IPQ consequences), all predicted degree of
disability (WASA) at 12 months for both intervention groups
(Table 1). In the fully adjusted model, a lower level of
Mebeverine Mebeverine+CBT
B (95% CI) P B (95% CI) P
0.598 (0.414-0.782) b.001 0.443 (0.248-0.638) b.001
0.658 (0.445-0.870) b.001 0.482 (0.237-0.727) b.001
0.202 (0.135-0.270) b.001 0.160 (0.093-0.227) b.001
6.354 (4.253-8.456) b.001 5.492 (3.226-7.757) b.001
 S.E. Reme et al. / Journal of Psychosomatic Research 68 (2010) 385388
Table 2
Adjusted models for each treatment group separately
Outcome: work and social adjustment 12 months
Predictor variables
Work and social adjustment (higher score=more disability)
Psychological distress (anxiety and depression) (higher score=more distress)
Behavioral scale (higher score=more adaptive behavior)
IPQ consequences (higher score=worse consequences)
psychological distress (anxiety and depression combined)
was the only significant predictor in the mebeverine group
(Table 2). In the fully adjusted model for the mebeverine
+CBT group less adaptive IBS-behavior at baseline
predicted better WASA outcome at 12 months. The fully
adjusted model explained a total variance of 40% for the
mebeverine group and 38% for the mebeverine+CBT group.
Discussion
This is the first study to examine predictors of treatment
outcome in IBS patients receiving CBT and mebeverine in
the context of a RCT in primary care. The results showed
that more psychological distress (anxiety and depression) at
baseline predicted more disability (WASA) at 1-year
follow up in the mebeverine group, while less adaptive
IBS behavior at baseline predicted less disability (WASA)
at 1-year follow up in the mebeverine+CBT group.
The results partly confirmed our hypothesis that psycho-
logical distress would predict a poor outcome. However, we
only found this for the mebeverine only group, not for the
mebeverine+CBT group. This result therefore deviates from
previous findings [14] indicating that psychological
distress does not interfere with a successful treatment course
of CBT and, therefore, could be recommended to IBS
patients with comorbid psychological symptoms.
The results also showed that those IBS patients who
presented more maladaptive behavior (e.g., avoidance
behavior) and received mebeverine+CBT treatment, experi-
enced less disability after 12 months. This could imply that
the CBT treatment was especially effective in changing
maladaptive IBS-coping behavior (e.g., avoidance behavior),
leading to less disability in terms of better work and social
adjustment. The clinical implications of this finding could be
to recommend CBT treatment to IBS patients presenting in
primary care with maladaptive IBS-coping behavior. The
IBS-coping behavior was investigated through a new
questionnaire designed for measuring coping behaviors in
IBS and has therefore never been reported before as far as we
know. Since IBS-coping behavior was found to predict
treatment outcome, future studies should consider including
this questionnaire for research as well as clinical purposes.
The results strengthen the validity of the CBT model for
IBS patients [16] in that both emotional (anxiety and
depression), cognitive (IPQs), and behavioral (IBS behavior)
387
Mebeverine Mebeverine+CBT
B (95% CI) P B (95% CI) P
0.071 (0.306 to 0.468) .68 0.274 (0.021 to 0.520) .07
0.388 (0.065 to 0.936) .025 0.001 (0.338 to 0.335) .99
0.051 (0.20 to 0.187) .11 0.285 (0.002 to 0.210) .045
1.984 (2.938 to 5.023) .60 0.199 (1.201 to 6.208) .18
factors were significant predictors of treatment outcome in
the adjusted and/or unadjusted analyses, indicating that all
these factors are important in the treatment of IBS patients.
The relatively small sample size is a limitation in the
current study. However, compared to most comparative
studies (e.g., Refs. [13]), our study has a reasonably high
number of patients included in the analyses and, therefore,
does not violate the recommendations for sample size in
linear regression [17]. However, similar studies should be
conducted in order to replicate these findings, particularly in
the primary care setting.
In conclusion, the results showed that lower levels of
psychological distress (anxiety and depression) predicted
less disability at 12 months for the mebeverine group but not
for the mebeverine+CBT group. The results further showed
that maladaptive IBS behavior predicted less disability at
12 months for the mebeverine+CBT group. Clinical
implications could involve recommending CBT to those
patients with IBS in primary care who are engaging in
unhelpful coping behavior.
Acknowledgments
We would like to thank the Health Technology
Assessment program for funding this study. We would
also like to thank the study nursesRebecca Holt, Tricia
Lewis, Sheila Morton, and Lindsey Shephardfor their
contribution, as well as the patients, doctors, and staff at the
participating general practices. Trudie Chalder acknowl-
edges financial support from the Department of Health via
the National Institute for Health Research Specialist
Biomedical Research Centre for Mental Health award to
South London and Maudsley NHS Foundation Trust and the
Institute of Psychiatry at King's College London. Finally, we
would like to thank Stein Atle Lie who provided valuable
statistical advice in the revision process of the article.
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