Does Cognitive-behavioural Therapy (CBT) improve psychological and/or clinical outcomes in inflammatory bowel disease (IBD)? A pilot randomised control trial
Dr Antonina Mikocka-Walus, University of South Australia
Eligible patients (mild/quiescent IBD, ≥18 years) were randomised to be offered usual medical care (control group) or usual care plus group CBT (experimental group). The experimental group attended 10 two-hour weekly CBT sessions (either face-to-face or online) and has been reassessed at 10 weeks, six, 12 and 24 months. The control group has had routine care as directed by their physician and six, 12 and 24 month follow-up.
To date, 57 patients have participated in the CBT program and 55 patients have been controls.
Impact of CBT on Disease Activity
Patients with Crohn’s disease and ulcerative colitis were analysed separately, since different disease activity measures were used.
Disease Activity in Patients Suffering from Crohn’s Disease
The mean baseline Crohn’s Disease Activity Index (CDAI) score in the experimental group was 109.7 (64) while it was 75.3 (86.3) in the control group. This difference was reaching significance (p=.057). Changes in disease activity over time are illustrated in Figure 1. A trend towards reduced disease activity in the experimental but not control group is clearly noticeable. However, when the analysis of covariance was conducted to evaluate whether group allocation predicted disease activity at 6 months this was found to be statistically not significant. The [statistical] power of this test however was very low, indicating the sample size is too small to reach reliable results. In addition, a similar analysis for 12 and 24 month disease activity outcomes was attempted but there were two few cases with data available for CDAI for these time points to draw meaningful conclusions. Thus, the trend towards reduction in the disease activity in the experimental group will need to be re-examined when more participants return 6- 24 month questionnaires.
Disease Activity in Patients Suffering from Ulcerative Colitis
Simple Clinical Colitis Activity Index (SCCAI) proved to be an unreliable measure of disease activity in the present study. Its results did not correlate with patient and doctor evaluation of disease activity. Scores for all patients but one indicated an active disease throughout the trial duration. Yet participants were only recruited if a patient and a doctor agreed the disease was quiescent. Nevertheless, a trend similar to the one showed in the case of the CDAI can be observed (fig. 2). Due to the low reliability of these data, further analysis was not conducted on the SCCAI.
Patient Subjective Measure of Disease Activity
As part of the survey completed by participants at each time point, patients were asked to qualitatively evaluate their disease activity by answering the question: How well-controlled is your disease? This measure showed that the large majority of patients had a good control of their disease over the trial period. The frequencies for patients who did not feel the disease was well controlled are provided below graphically (fig. 3).
CBT was found to reduce C-reactive protein (CRP) levels at six months. Comparisons at 12 and 24 months were conducted but were inconclusive; likely due to small numbers and thus this analysis will be repeated when more cases have follow-up assessments available.
Impact of CBT on Mental Health and Quality of Life
Psychological coping was coded into adaptive and maladaptive. In the experimental group, the adaptive coping increased between baseline and 12 months and the groups differed significantly on adaptive coping at this time point at the univariate level. However, when a model was built, this difference showed to only reach [statistical] significance, with a medium level of power.* See figures 4 and 5 below.
A less clear trend in maladaptive coping was observed. It seems a drop in maladaptive coping can be observed in the control group over time. However, groups do not statistically differ on maladaptive coping at any time point.
Changes in anxiety were explored with the use of the State Trait Anxiety Inventory (STAI) which provides measures of state anxiety (anxiety in the current moment) and trait anxiety (general personal predisposition to anxiety). Trends towards reduction in both state and trait anxiety in the experimental but not control group can be observed (fig. 6).
The groups differed at baseline in their perception of stress, with the experimental group reporting more stressful events in their life. A temporal trend toward reduced stress in the experimental but not in the control group can be observed (fig. 7). However, group allocation did not significantly predict stress at six months, 12 months, or 24 months*.
Quality of Life
A trend towards poorer physical quality of life in the experimental group can be observed between baseline and 12 months, with a sudden improvement at 24 months. The groups however do not significantly differ at any of these time points, demonstrating no effect of CBT on physical quality of life. However, power of these analyses was low, indicating more cases are needed in order to obtain meaningful results.
No significant differences* in mental quality of life was noted at any of the time points, indicating no impact of CBT on mental quality of life at six months, 12 months, or 24 months.
Face-to-Face Versus Online CBT
Overall, 18 patients participated in the face-to-face CBT and 39 in online CBT. A load effect was observed in the case of face-to-face CBT, with those Crohn’s disease patients attending more sessions having lower disease activity at 12 months. This was however not observed in the case of online CBT, at this stage possibly due to low numbers of participants who completed long-term follow-up.
There was no difference between face-to-face and online CBT with respect to their impact on anxiety both at 10 weeks and six months, nor on depression at 10 weeks and six months, and no differences with respect to psychological coping, quality of life or stress at 10 weeks or six months were noticeable*. However, these trends are reassuring with respect to potential cost savings due to the use of online program rather than employing a psychologist to run groups.
The most important findings from the trial are:
- CBT was found effective in reducing number of people with poor coping with IBD at six and12 months and increasing the number of people who are confident in actively managing the disease at 12 months;
- A trend towards CBT reducing disease activity at six months for both CD and UC participants was observed;
- A trend towards CBT increasing adaptive coping at 12 months was observed;
- A trend towards CBT reducing anxiety (both state and trait) at six months was observed;
- A trend towards CBT reducing stress at 12 and 24 months was observed;
- Similar, efficacy of face-to-face and online CBT in terms of their impact on mental health,quality of life, stress and coping was identified;
- A dose effect in face-to-face therapy, with the more sessions attended, the lower the disease activity at 12 months, was found.
* Most of the analyses were associated with low statistical power, indicating more cases are needed for the analysis to be meaningful. The study will be continued in order to obtain more data at six, 12 and 24 months.
This article was first published in theWinter 2012 edition of Inside Insight.