ORLANDO — A self-administered protocol for cognitive behavioral therapy that requires minimal clinician contact can be just as effective at relieving the symptoms of irritable bowel syndrome (IBS) as traditional therapy delivered in a clinical setting, new research shows.
With this protocol, “for the most part, symptom improvement is sustained out to 3 months and 6 months,” said investigator Jeffrey Lackner, PsyD, from the University of Buffalo School of Medicine in New York.
These findings — which received an American College of Gastroenterology Governors Award for Excellence in Clinical Research — suggest that home-based treatments could be used to relieve chronic constipation, diarrhea, bloating, gas, and other IBS symptoms in more patients without increasing clinician time or the use of healthcare resources.
In April 2017, the National Institute for Health and Care Excellence (NICE) in the United Kingdom updated its guidelines on the diagnosis and treatment of IBS in adults. Patients who continue to experience IBS symptoms despite at least 12 months of pharmacologic treatment should be referred for cognitive behavioral therapy, hypnotherapy, or psychological therapy, the guidelines state.
“The problem is that only a small fraction of people receive cognitive therapy in accordance with practice guidelines,” said Dr Lackner. Therefore, “there is a demand for treatments that maintain efficacy but are more efficient to implement.”
“One strategy is to decrease therapist contact time using home-based treatments,” he said here at the World Congress of Gastroenterology.
For their study, Dr Lackner and his colleagues randomized 438 adults with moderate to severe IBS, diagnosed using Rome III criteria, to four 1-hour sessions of self-administered therapy, 10 sessions of standard psychiatrist- or psychologist-led therapy, or four sessions of education only. They assessed symptom relief at 12 weeks, 3 months, and 6 months.
A Durable Response
Significantly more patients in the self-administered therapy group than in the education-only group responded to the intervention — defined as moderate or substantial improvement — at 12 weeks (67.8% vs. 46.2%; P < .05) and at 3 months (63.8% vs. 49.2%; P < .05). At 6 months, the difference did not meet the threshold for significance (63.2% vs 50.5%; P < .07).
Patients’ self-reported improvements closely mirrored the global assessments of gastroenterologists blinded to group assignment. At 12 weeks, the clinicians identified as responders 63% of the patients in the self-administered therapy group and 43% of the education-only group. They also identified 60% of patients in the standard therapy group as responders.
“Cognitive behavior therapy appears to have an enduring effect that protects against relapse and recurrence in a sizable sample,” Dr Lackner reported.
Self-administered therapy “is at least as efficacious as standard therapy in improving IBS symptoms,” according to formal equivalence testing, he said. “This raises the question of whether there is some disease-modifying quality to cognitive behavioral therapy.”
How Therapy Might Work in IBS
It is unlikely that the improvements seen in this study are related to a placebo response, which typically dissipates over time and is characterized by the return of symptoms after treatment withdrawal, Dr Lackner said.
The therapeutic strategy is designed to target factors that maintain IBS, particularly the faulty ways of processing information that dysregulate brain–gut interactions and can lead to gastrointestinal symptoms, Dr Lackner said. Three central assumptions are that patients have specific skill deficits that render them vulnerable to GI flare-ups, that formal training in these skills can modify faulty thinking patterns, and that remediation of these skill deficits will improve IBS symptoms.
It is important for physicians to destigmatize cognitive therapy as a treatment for IBS.
“It is important for physicians to destigmatize cognitive therapy as a treatment for IBS,” said Sarah Kinsinger, PhD, a behavioral medicine expert in the division of gastroenterology and nutrition at the Loyola University Medical Center in Maywood, Illinois. “I recommend describing this as a brain–gut treatment that is targeting the digestive condition, not a psychological disorder,” she told Medscape Medical News.
“IBS can be a difficult-to-treat condition that causes significant quality-of-life impairment,” she added. “For patients who have failed other treatment approaches, cognitive therapy is a reasonable option, and may be especially appealing to patients who are looking for a nonpharmacologic treatment approach.”
Session comoderator Peter Gibson, MD, from Monash University in Melbourne, Australia, asked about patient predictors of clinical response.
“That’s a terrific question,” Dr Lackner said. “We found two very interesting factors, two baseline characteristics: trait anxiety, which is akin to neuroticism; and anxiety sensitivity, or fear of arousal symptoms.”
After the presentation, a member of the audience asked about compliance in the two cognitive therapy groups.
“There was no difference,” Dr Lackner said. “One would think that minimal contact is prone to noncompliance. I actually think there is a catalytic quality to these minimal-contact treatments that changes the dynamics between a doctor and a patient. There is only four hours to spend, and the responsibility is for the patients to carry out the therapy in an environment where the symptoms appear, which is an important aspect of this study.”
‘Extremely Good Results’
“There have been a lot of studies on cognitive therapy, and I don’t think this had different results than other studies because it is effective,” Dr Gibson told Medscape Medical News. “What is really interesting about this is that they got extremely good results from a minimal context, and at home.”
“One of the biggest problems with psychological therapies is that most are delivered by a psychologist, and there aren’t enough psychologists around in IBS to do it,” he pointed out. “That’s why internet-based, home-based approaches are being evaluated. Some of the internet-based ones have not been as good, but this one is very impressive.”
This study demonstrates that the minimal-contact approach has equivalent results as a more lengthy and burdensome treatment course [10 sessions],” said Dr Kinsinger, who recently published a review article on cognitive therapy in IBS (Psychol Res Behav Manag. 2017;10:231-237).
“This has important implications for patient care, given that time and cost are common barriers to patient participation in treatment,” Dr Kinsinger said. “These findings indicate that cognitive therapy can be delivered in a highly efficient way to overcome some of these barriers.”
Dr Lackner, Dr Gibson, and Dr Kinsinger have disclosed no relevant financial relationships.
World Congress of Gastroenterology at ACG 2017: Abstract 49. Presented October 17, 2017.
Follow Medscape Gastroenterology on Twitter @MedscapeGastro and Damian McNamara @MedReporter
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