Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial

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

Review article: current and future treatment approaches for pain in IBS

“…Emerging psychological approaches for IBS pain (Table 1) include a digitally delivered CBT program for IBS called Zemedy which reduced visceral sensitivity and may improve affordability and accessibility. 121 Skype delivered hypnotherapy was effective but slightly less so than face-to-face treatment for a 30% or more abdominal pain reduction. 122 Written expressive disclosure, which comprises patients writing about their deepest thoughts and feelings about IBS appeared to increase pain self-efficacy and reduce healthcare use compared to control writing in an RCT.…”

Acceptability and efficacy of the Zemedy app versus a relaxation training and meditation app for IBS: protocol for a randomised controlled trial

“…Because there is considerable overlap between the basic design and materials of this study and the published study of Zemedy V.1.0, 27 there is also considerable overlap between the two papers in the description of the basic methods, materials and data analysis plan. Rather than referring readers to the prior paper, some of that text is reproduced here.…”

“…V.1.0 of the app was tested in an RCT against a waitlist control. 27 Primary outcome measures included both GI symptom severity and HRQL. Secondary outcome measures included GI-specific catastrophising, visceral anxiety, fear of food and depression.…”

“…The Zemedy app was developed to deliver CBT for IBS directly to users with no direct therapist or clinician interaction required. V.1.0 of the app was tested in an RCT against a waitlist control 27. Primary outcome measures included both GI symptom severity and HRQL.…”

Understanding the user: Patients’ perception, needs, and concerns of health apps for chronic constipation

“… 7 In patients with irritable bowel syndrome, health apps such as Zemedy and Heali have reported improvements in quality of life and burden of illness following four to eight weeks of self-management using the apps. 8 , 9 Nevertheless, despite the potential of health apps as effective and efficient tools for gastroenterology, minimal studies have explored health apps as tools in patients with chronic constipation.…”