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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- outcome in the mebeverine group [=0.388 (95% CI: 0.065
patients who participated in a randomized controlled trial in 0.936), P=.025] but not in the mebeverine+CBT group. In the
primary care, where 149 irritable bowel syndrome (IBS) patients adjusted model for the mebeverine+CBT group less adaptive IBS
were randomized to mebeverine hydrochloride (n=77) or mebe- related behavioral coping predicted a good outcome [=0.285
verine+cognitive behavior therapy (CBT) (n=72). CBT offered (95% CI: 0.0020.210), P=.045]. Conclusion: Different factors
additional benefit over mebeverine alone. Methods: Regression are associated with outcome depending on the treatment
analyses were used to identify predictors of work and social received. At assessment clinicians should assess patients coping
adjustment 12 months after treatment ended. The intervention styles and may want to consider recommending CBT to those
groups were analyzed separately in order to look at the separate patients with IBS in primary care who are engaging in unhelpful
effects in each group. Results: Lower levels of psychological coping behavior.
distress (anxiety and depression) at baseline predicted a good 2010 Elsevier Inc. All rights reserved.
Keywords: Cognitive behavior therapy; Irritable bowel syndrome; Primary care; Predictors of treatment outcome; Clinical implications

Introduction psychological treatments reveal results that point in the


opposite direction [5,6].
Few studies have looked specifically at predictors of Symptom characteristics also show some inconsistencies
treatment outcome after cognitive-behavioral treatments in the literature, in that severity of gastrointestinal symptoms
(CBT) for irritable bowel syndrome (IBS). Those who predicted a poor outcome in one study [1] and a good
have find psychological disturbance to be an important outcome in another [7]. Conflicting results may reflect the
predictor of a poor outcome. Less baseline anxiety predicted different measures of outcome or criterion used, the
a better outcome in one study [1], whereas others have found intervention received, or lack of statistical power due to
a lower likelihood of success with the presence of one or few participants in the studies.
more psychiatric disorders [2,3] and baseline depression [4]. In a recent randomized controlled trial (RCT) from
Although psychological distress overall seems to predict a primary care where CBT was added to antispasmodic
poor outcome in CBT treatments, studies from other 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
Corresponding author. Research Centre for Health Promotion, Faculty
find out who may benefit from which treatment, predictors of
of Psychology, University of Bergen, Christies gt 13, 5015 Bergen, Norway.
treatment outcome need to be identified. This article reports
Tel.: +47 55583991; fax: +47 55 58 98 78. on predictors of treatment outcome through a secondary
E-mail address: silje.reme@uib.no (S.E. Reme). analysis of the aforementioned RCT in primary care. We

0022-3999/10/$ see front matter 2010 Elsevier Inc. All rights reserved.
doi:10.1016/j.jpsychores.2010.01.003
386 S.E. Reme et al. / Journal of Psychosomatic Research 68 (2010) 385388

chose predictors which represented the multidimensional after treatment ended. IBS tends to be a chronic condition
nature of the disorder and included measures of distress, and the 12-month follow-up was therefore chosen as the
unhelpful perceptions/cognitions, and behavioral coping. outcome in this study. WASA was a secondary outcome in
Based on previous findings, we hypothesized that psycho- the trial but was chosen as the main outcome of this study
logical distress (anxiety and depression) would predict a poor since health status and functionality can be argued to be
treatment outcome at 12 months of follow-up for both groups. 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
Method
variables were continuous, and the association between
them was assumed to be linear. Multiple linear regression
Patients diagnosed with IBS aged 1650 years were
analyses were therefore chosen. Unadjusted and adjusted
recruited from 10 general practices in London. Three hundred
analyses were used to assess the strength of relationships
thirty-four patients were referred to the study; 235 consented
between hypothesized predictors and outcome. All models
to participate, and those still symptomatic (moderate to severe
were stratified by intervention group and examined
IBS symptoms) after 2 weeks of general practitioner care and
separately in order to assess determinants of outcome for
4 weeks of mebeverine hydrochloride (275 mg 3 times a day)
each treatment. Statistically significant predictors (Pb.01)
were included in the trial (n=149). Of those consenting to
from the unadjusted analyses were included in an adjusted
participate, 52 were no longer symptomatic at the time of
regression model.
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 Results
(77 patients). Four general practice nurses delivered the CBT.
All participants were asked to complete a series of In the previous study, the addition of CBT to mebeverine
questionnaires. Of these, the following were hypothesized to produced a significant benefit compared with the
predict treatment outcome: psychological distress (anxiety mebeverine-only group on symptom severity and WASA.
and depression combined score) [9,10], illness perceptions The difference on the WASA scale represented therapeutic
(IPQs) [11], IBS symptoms [12], cognitions about IBS [13], gains of approximately 20% and 40%, respectively. The
and IBS-related coping behavior. The latter is a new improvements began to wane over time, and by 12 months
questionnaire designed and validated by the researchers. It of follow-up, significant therapeutic benefit of the addition
allows assessment of changes in specific coping behaviors of CBT could only be detected on the WASA scale. Full
used by patients with IBS and includes items related to details of main findings and response rates are reported
avoidance behavior and toileting behavior. It was found to be elsewhere [8]. Most patients were women (85%), mean age
both valid and reliable (Cronbach's =.89) [14]. The primary was 33.8 years (S.D. 9.1), and the majority were Caucasian
outcome for the prediction analyses was the work and social British (69%); 50% had experienced IBS for more than
adjustment (WASA) scale at 12 months of follow-up which 5 years, and 52% reported psychological problems during
measures ability to work, manage the home, and participate the last 5 years.
in social and private leisure activities and relationships. The Follow-up data on the WASA scale at 12 months were
scale ranges from 0 to 40, with higher scores indicating more available from 73% of the participants, 71% in the
disability [15]. mebeverine+CBT group (n=51) and 75% in the mebeverine
Ethical approval was received from St. Thomas' Hospital group (n=58).
Research Ethics Committee; Guy's Hospital Research Ethics The results from the unadjusted analyses showed that
Committee; and Barnet, Enfield, and Haringey LREC. baseline WASA scores, psychological distress (anxiety and
depression), IBS-coping behavior, and a belief that the IBS
Statistical analyses would have serious consequences for the patient's life, health
and well-being (IPQ consequences), all predicted degree of
All analyses were performed using SPSS version 15. The disability (WASA) at 12 months for both intervention groups
participants filled out questionnaires 3, 6, 9, and 12 months (Table 1). In the fully adjusted model, a lower level of

Table 1
Unadjusted models for each treatment group separately; only significant (Pb.01) predictors included
Outcome: work and social adjustment 12 months Mebeverine Mebeverine+CBT
Predictor variables B (95% CI) P B (95% CI) P
Work and social adjustment (higher score=more disability) 0.598 (0.414-0.782) b.001 0.443 (0.248-0.638) b.001
Psychological distress (anxiety and depression) (higher score=more distress) 0.658 (0.445-0.870) b.001 0.482 (0.237-0.727) b.001
Behavioral Scale (higher score=more adaptive behavior) 0.202 (0.135-0.270) b.001 0.160 (0.093-0.227) b.001
IPQ consequences (higher score=worse consequences) 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 387

Table 2
Adjusted models for each treatment group separately
Outcome: work and social adjustment 12 months Mebeverine Mebeverine+CBT
Predictor variables B (95% CI) P B (95% CI) P
Work and social adjustment (higher score=more disability) 0.071 (0.306 to 0.468) .68 0.274 (0.021 to 0.520) .07
Psychological distress (anxiety and depression) (higher score=more distress) 0.388 (0.065 to 0.936) .025 0.001 (0.338 to 0.335) .99
Behavioral scale (higher score=more adaptive behavior) 0.051 (0.20 to 0.187) .11 0.285 (0.002 to 0.210) .045
IPQ consequences (higher score=worse consequences) 1.984 (2.938 to 5.023) .60 0.199 (1.201 to 6.208) .18

psychological distress (anxiety and depression combined) factors were significant predictors of treatment outcome in
was the only significant predictor in the mebeverine group the adjusted and/or unadjusted analyses, indicating that all
(Table 2). In the fully adjusted model for the mebeverine these factors are important in the treatment of IBS patients.
+CBT group less adaptive IBS-behavior at baseline The relatively small sample size is a limitation in the
predicted better WASA outcome at 12 months. The fully current study. However, compared to most comparative
adjusted model explained a total variance of 40% for the studies (e.g., Refs. [13]), our study has a reasonably high
mebeverine group and 38% for the mebeverine+CBT group. 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
Discussion conducted in order to replicate these findings, particularly in
the primary care setting.
This is the first study to examine predictors of treatment In conclusion, the results showed that lower levels of
outcome in IBS patients receiving CBT and mebeverine in psychological distress (anxiety and depression) predicted
the context of a RCT in primary care. The results showed less disability at 12 months for the mebeverine group but not
that more psychological distress (anxiety and depression) at for the mebeverine+CBT group. The results further showed
baseline predicted more disability (WASA) at 1-year that maladaptive IBS behavior predicted less disability at
follow up in the mebeverine group, while less adaptive 12 months for the mebeverine+CBT group. Clinical
IBS behavior at baseline predicted less disability (WASA) implications could involve recommending CBT to those
at 1-year follow up in the mebeverine+CBT group. patients with IBS in primary care who are engaging in
The results partly confirmed our hypothesis that psycho- unhelpful coping behavior.
logical distress would predict a poor outcome. However, we
only found this for the mebeverine only group, not for the Acknowledgments
mebeverine+CBT group. This result therefore deviates from
previous findings [14] indicating that psychological We would like to thank the Health Technology
distress does not interfere with a successful treatment course Assessment program for funding this study. We would
of CBT and, therefore, could be recommended to IBS also like to thank the study nursesRebecca Holt, Tricia
patients with comorbid psychological symptoms. Lewis, Sheila Morton, and Lindsey Shephardfor their
The results also showed that those IBS patients who contribution, as well as the patients, doctors, and staff at the
presented more maladaptive behavior (e.g., avoidance participating general practices. Trudie Chalder acknowl-
behavior) and received mebeverine+CBT treatment, experi- edges financial support from the Department of Health via
enced less disability after 12 months. This could imply that the National Institute for Health Research Specialist
the CBT treatment was especially effective in changing Biomedical Research Centre for Mental Health award to
maladaptive IBS-coping behavior (e.g., avoidance behavior), South London and Maudsley NHS Foundation Trust and the
leading to less disability in terms of better work and social Institute of Psychiatry at King's College London. Finally, we
adjustment. The clinical implications of this finding could be would like to thank Stein Atle Lie who provided valuable
to recommend CBT treatment to IBS patients presenting in statistical advice in the revision process of the article.
primary care with maladaptive IBS-coping behavior. The
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