NewS & VIewS

IBS therapeutic value of the two active CBT treat-

ments? Unfortunately, the study did not for-

Cognitive behavioural therapy

mally establish the comparative effectiveness
of web-​based CBT versus clinician-​assisted
telehealth CBT, so the question that was

for IBS: results or treatment as such a compelling argument for the trial is
unanswered.
TAU certainly has its place, particularly
usual? early in therapy development to control for
threats to internal validity arising from his-
tory, maturation, the effects of repeated
Paul Enck   and Jeffrey M. Lackner assessment and statistical regression6. But
Telephone or web-​based psychotherapy has been suggested to be as effective at this development stage, a TAU condition
complicates the interpretability of study
as face-​to-face psychotherapy while lowering access restrictions and results because it does not shed light on the
improving patient acceptability. A large new study in patients with IBS shows specificity of treatment effects. Indeed, tri-
the superiority of such an approach in comparison with treatment as usual. als that feature TAU are particularly vulner­
able to overestimating the magnitude of the
Refers to Everitt, H. A. et al. Assessing telephone-​delivered cognitive–behavioural therapy (CBT) and web-​delivered experimental condition treatment effects.
CBT versus treatment as usual in irritable bowel syndrome (ACTIB): a multicentre randomised trial. Gut https://doi.org/
10.1136/gutjnl-2018-317805 (2019).
Furthermore, a patient being randomly
assigned to a TAU trial arm is worse than
Interest in the role of psychotherapy in gas- of six 60 min sessions with a therapist over being randomly assigned to a classic waiting
troenterology has escalated in the past few the telephone over 9 weeks followed by two list control arm that has often been used in
decades, with a rising number of publica- booster sessions (8 hours total support) or psychotherapy trials. TAU assignment tells the
tions on the topic. For IBD, this focus on the web-based delivery with 2.5 hours of ther- patient that they will not receive better treat-
potential of psychotherapy might be related apist support. These treatments were com- ment than they had in the past, and as they are
to disappointment regarding the clinical pared with a passive treatment as usual (TAU) not satisfied with this treatment (indicated by
yield of genetics1 and growing recognition approach that included patient education per the fact that they are enrolling in the study)
of the effect of environmental factors (stress) National Health Service guidelines for IBS. this is equivalent to being told “wait until the
on disease progression in IBD2–4 and IBS4. Results showed that both CBT conditions study is over and then you will have a chance
At the same time, we have a growing arsenal were more effective in reducing the severity to get the new treatment”. This approach, used
of robust behavioural treatments for refrac- of IBS symptoms than TAU at the 3-month in ACTIB, is analogous to putting a patient
tory patients. The newly published Assessing follow-​up. Treatment gains were maintained on a waiting list but not including their data
Cognitive behavioural Therapy in Irritable at the 12-month follow-​up. The trial has in the study, which would be done using a
Bowel (ACTIB) study5 is an example of such numerous strengths, including well-​defined waiting list control group. TAU and waiting
an approach. treatment protocols and eligibility criteria, a list control groups poorly control for spon-
The purpose of ACTIB was to assess the large sample, intention-​to-treat analyses, sus- taneous symptom variation and not other
efficacy of a specific psychological therapy, tained follow-​up, psychometrically validated factors. Other trial designs offer improved
cognitive behavioural therapy (CBT), in a end points and a reasonably well-​defined trial control of spontaneous symptom variation
large sample of patients with IBS (n = 559) architecture. In this respect, ACTIB improves and other factors: cluster randomization and
who had persistent gastrointestinal symptoms on the methodological shortcomings of cohort multiple randomized controlled trials,
lasting over 12 months. CBT seeks to teach earlier trials of behavioural therapy in IBS6. to name a few7.
behavioural self-​management skills for con- Where the trial falls short is in its explana- For a trialist, there are at least three major
trolling refractory IBS symptoms. The cog- tory power. The rationale for the ACTIB study issues with TAU controls: as in ACTIB, TAU
nitive component of CBT targets distorted is based on an understanding that usual care is usually neither controlled nor standardized;
information processing such as prediction — medications and lifestyle changes — is the nonspecific effects of psychotherapy due
errors, whereas its behavioural component inadequate for refractory patients. Indeed, to expectancy of improvement and amount of
targets maladaptive behaviours such as exces- their unsatisfactory track record is partly what time spent with the clinician are not explained
sive avoidance, poor problem solving and drives the personal and economic costs that and this amount of attention can vary dramat-
reliance on safety behaviours. An innova- led to the undertaking of ACTIB. A clinical ically between the treatment and TAU groups,
tive aspect of the trial was to use two novel trial whose primary comparator is ineffec- which is neither assessed nor statistically
treatment delivery systems for implementing tive is problematic for two reasons. First, it controlled; and attention is a major driver of
CBT that has historically, and inefficiently, reinforces what we already know. Second, placebo responses8. Because there is no non-
been delivered in person and one-​to-one in it does not tell us what we need to know to specific comparator (a placebo) control, the
clinical settings. In ACTIB, CBT consisted improve clinical practice: what is the relative observed differential effects of the two active

Nature Reviews | Gastroenterology & Hepatology

News & Views
Therapy-specific
effects
Nonspecific
effects
Methodological
biases
Regression
to the mean
Natural course
of disease
Active Therapy Passive
control control
• WL
• TAU
Fig. 1 | Control groups in psychotherapy
trials. In an active-​placebo controlled trial, the
control arm includes methodological effects
(regression to the mean and biases) and sponta-
neous symptom variation, plus nonspecific
(that is, placebo) effects8. It is generally
assumed that these are similar in the therapy
arm following randomization and therefore
enable subtraction from the total therapy
effect. With passive waiting list (WL) and
treatment as usual (TAU) controls, the placebo
effect is decreased owing to disappointment
and might lead to overestimation of therapy
specific effects.
treatment arms could to some extent be due
to placebo and differ only because of the
modalities used to provide the placebo. Again,
there are alternative methods for addressing
this issue, such as step-​wedge or preference
designs9, instead of assuming that treatment
effects are due to the technical components
of CBT.
We are not saying that the effects of the
ACTIB study can be easily dismissed as a pla-
cebo effect. Rather, we are merely stating that
its design and analysis plan does not disentan-
gle how much of the observed effect at the end
of a CBT trial is due to technical components
as opposed to nonspecific effects (such as pla-
cebo, attention or therapeutic alliance) that
are common to all treatments regardless of
modality (Fig. 1).
The past 20 years has seen increased
sophistication in the quality and complexity
of behavioural trials for IBS. In the absence of
satisfactory medical therapies, behavioural
treatments — particularly CBT — have emer­
ged as a viable treatment option with effects
not limited to helping patients cope with the
emotional unpleasantness of their condition.
CBT seems to have very real therapeutic ben-
efits in improving even the most severe IBS
symptoms10. These effects are largely but not
wholly due to its technical components. How
CBT achieves its goals requires that gastroen-
terologists, behavioural scientists and funding
agencies (which often request TAU as a com-
parator) temper their enthusiasm, allegiances
and expectations to ensure that the conven-
tions and procedures that govern the rigorous
validation of medical therapeutics extend to
non-​drug therapies.
Paul Enck   1 and Jeffrey M. Lackner2*
1
Department of Internal Medicine VI: Psychosomatic
Medicine and Psychotherapy, University Hospital,
Tübingen, Germany.
Division of Behavioral Medicine, Department
2
of Medicine, Jacobs School of Medicine and
Biomedical Sciences, University at Buffalo, Buffalo,
NY, USA.
*e-​mail: lackner@buffalo.edu
https://doi.org/10.1038/s41575-019-0174-2
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Opportunities of twin research in gastroenterology.
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(2018).
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therapy reduces psychological stress in patients with
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935–945 (2019).
3. Hood, M. M. & Jedel, S. Mindfulness-​based
interventions in inflammatory bowel disease.
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cognitive–behavioural therapy (CBT) and web-​delivered
CBT versus treatment as usual in irritable bowel
syndrome (ACTIB): a multicentre randomised trial.
Gut. https://doi.org/10.1136/gutjnl-2018-317805
(2019).
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Competing interests
The authors declare no competing interests.
www.nature.com/nrgastro