Plain language summary
Cognitive behavioural therapy (CBT) is a proven treatment method to tackle many psychiatric issues. Irritable bowel syndrome (IBS) is considered a chronic gastrointestinal disorder with psychiatric comorbidity. However, patients find it difficult to access CBT for IBS management. As per previous research findings, web-based and telephone-based CBT, self-help CBT books and CBT treatment manuals offer promising therapeutic effects in improving IBS. Therefore, this crossover randomised controlled trial aimed to look at the efficacy of Zemedy, a mobile digital therapeutic application that provides a comprehensive CBT programme to IBS patients. This study found that Zemedy is an effective modality that increases access to effective CBT treatment for IBS patients. Results showed significant improvement in gastrointestinal symptoms, irritable bowel syndrome quality of life, gastrointestinal cognition, visceral sensitivity, fear of food, depression, and improved health-related quality of life in 62 IBS patients enrolled in the immediate treatment group. Further robust studies are required to determine the efficacy of digital applications in IBS patients with significantly higher psychiatric comorbidity. Healthcare practitioners can use the results of the study to understand the importance of digital applications and make them part of intervention strategies.
Abstract
BACKGROUND Patients with irritable bowel syndrome (IBS) experience abdominal pain, altered bowel habits, and defecation-related anxiety, which can result in reduced productivity and impaired health-related quality of life (HRQL). Cognitive behavioral therapy (CBT) has been shown to reduce symptoms of IBS and to improve HRQL, but access to qualified therapists is limited. Smartphone-based digital therapeutic interventions have potential to increase access to guided CBT at scale, but require careful study to assess their benefits and risks. OBJECTIVE The aim of this study was to test the efficacy of a novel app, Zemedy, as a mobile digital therapeutic that delivers a comprehensive CBT program to individuals with IBS. METHODS This was a crossover randomized controlled trial. Participants were recruited online and randomly allocated to either immediate treatment (n=62) or waitlist control (n=59) groups. The Zemedy app consists of 8 modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy, behavioral experiments, and information about diet. Users interact with a chatbot that presents the information and encourages specific plans, homework, and exercises. The treatment was fully automated, with no therapist involvement or communication. At baseline and after 8 weeks, participants were asked to complete the battery of primary (Irritable Bowel Syndrome Quality of Life [IBS-QOL], Gastrointestinal Symptom Rating Scale [GSRS]) and secondary (Fear of Food Questionnaire [FFQ], Visceral Sensitivity Index [VSI], Gastrointestinal Cognition Questionnaire [GI-COG], Depression Anxiety Stress Scale [DASS], and Patient Health Questionnaire-9 [PHQ-9]) outcome measures. Waitlist controls were then offered the opportunity to crossover to treatment. All participants were assessed once more at 3 months posttreatment. RESULTS Both intention-to-treat and completer analyses at posttreatment revealed significant improvement for the immediate treatment group compared to the waitlist control group on both primary and secondary outcome measures. Gains were generally maintained at 3 months posttreatment. Scores on the GSRS, IBS-QoL, GI-COG, VSI, and FFQ all improved significantly more in the treatment group (F1,79=20.49, P<.001, Cohen d=1.01; F1,79=20.12, P<.001, d=1.25; F1,79=34.71, P<.001, d=1.47; F1,79=18.7, P<.001, d=1.07; and F1,79=12.13, P=.001, d=0.62, respectively). Depression improved significantly as measured by the PHQ-9 (F1,79=10.5, P=.002, d=1.07), and the DASS Depression (F1,79=6.03, P=.02, d=.83) and Stress (F1,79=4.47, P=.04, d=0.65) subscales in the completer analysis but not in the intention-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophizing and visceral sensitivity. CONCLUSIONS Despite its relatively benign physical profile, IBS can be an extraordinarily debilitating condition. Zemedy is an effective modality to deliver CBT for individuals with IBS, and could increase accessibility of this evidence-based treatment. TRIAL REGISTRATION ClinicalTrials.gov NCT04170686; https://www.clinicaltrials.gov/ct2/show/NCT04170686.
