A new mobile digital therapeutic, Zemedy, offers resources centred around cognitive behavioural therapy (CBT) that focus on gut-brain miscommunication and hypersensitivity around gut sensations happening for someone with irritable bowel syndrome (IBS).
Irritable bowel syndrome (IBS) affects up to 10% of the US population and costs upwards of US$1 billion a year in medical bills and lost productivity, according to Penn clinical psychologist Melissa Hunt, who has spent 15 years studying the condition.
However, typical treatments usually require people to adopt restrictive diets, keep symptom diaries, and reduce stress. They also incorporate over-the-counter laxatives and prescription medications called antispasmodics intended to help with cramping.
""It's an incredibly costly disorder that can be incredibly impairing to people's quality of life," said Hunt. “That kind of treatment is aimed at reducing symptoms. Nothing is actually targeting the underlying cause of the disorder. All of this leads to a terrible thing called visceral hypersensitivity, which is where people become much more aware of sensations in the gut, sensations most people wouldn't notice. The discomfort gets massively amplified in the brain, which then responds with stress hormones that exacerbate issues with the gut and can cause diarrhoea or constipation. But CBT changes how the brain processes stress."
Cognitive behavioural therapy focuses on changing the thought process and behaviour around a particular ailment. In the case of IBS, that could mean relaxation training and cognitive reframing or de-catastrophizing, for instance, or exposure therapy around foods and situations feared for their potential to cause GI distress.
These treatments have proven effective for IBS because the disorder likely results from a miscommunication between the central nervous system, which controls the brain, and the enteric nervous system, which orchestrates GI behaviour, coupled with something called dysbiosis, or a change in the gut microbiome.
To find out whether that alternative treatment was effective, Hunt and colleagues conducted a randomised control trial. They found that using version 1.0 of the app for eight weeks led to improvements in health-related quality of life, fewer gastrointestinal (GI) symptoms, and less anxiety about visceral sensations, benefits the participants retained three months later. The findings, ‘The Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-Management of Irritable Bowel Syndrome: a Cross-Over, Randomized Controlled Trial (Preprint)’, were published in JMIR mHealth and uHealth.
In this cross-over randomised controlled trial (registration number NCT04170686), patients were randomly allocated to either immediate treatment (n=62) or waitlist control (n= 59). The Zemedy app consists of eight modules focusing on psychoeducation, relaxation training, exercise, the cognitive model of stress management, applying CBT to IBS symptoms, reducing avoidance through exposure therapy and behavioural experiments, and information about diet.
"The idea is to change how people think about and react to the sensations in their gut and to decrease avoidance behaviour by using graduated exposure therapy. When we do that, visceral hypersensitivity goes way down," added Hunt. "People can actually live life again and eat whatever they want - a much better solution long term."
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 eight 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 outcome measures (the Fear of Food Questionnaire (FFQ), the Visceral Sensitivity Index (VSI), the GI Cognition Questionnaire (GI-COG), the Depression, Anxiety Stress Scale (DASS) and the Patient Health Questionnaire (PHQ-9)). Waitlist controls were then offered the opportunity to cross over. All participants were assessed one more time at three months post-treatment completion.
Four weeks later, participants in both groups received follow-up communication that encouraged the treatment group to use the resources provided and offered the control group general encouragement, along with a reminder that they were still enrolled in the study and notification that they would receive follow-up questionnaires in a month's time.
At the eight-week mark, all participants completed the same survey they took initially, and the waitlist group received access to the app. To ensure apples-to-apples data, this group—the original control arm of the study, completed another survey after using the app for eight weeks. Three months after participants completed their active treatment phase, they filled out one final survey.
The results showed that the app was effective at helping those who suffer from IBS. Both intent-to-treat and completer analyses at post-treatment 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 post-treatment.
Scores on the GSRS, IBS-QoL, GI-COG, and VSI all improved significantly more in the treatment group and fear of food also decreased for the treatment group relative to the control group. Depression improved significantly as measured by both the PHQ9 and the DASS Depression Subscale, as did the stress subscale of the DASS in the completer analysis but not the intent-to-treat analysis. The impact of treatment on HRQL was mediated by reductions in catastrophising and visceral sensitivity.
"The treatment group improved significantly compared to the control group," Hunt says. "Once the control group crossed over and started using the app, they saw significant benefit, too. And we had maintenance of gains for everyone."
Though the researchers acknowledge some limitations to the current study, including lack of a placebo control condition and lack of an explicit physician confirmation of the IBS diagnosis, they believe the findings point to the need for treatment options that don't require restrictive diets or hard-to-maintain lifestyle changes. CBT is a better long-term fix, Hunt explained, and she sees technology like this as a way to get that treatment into people's hands.
"What I am trying to do, what I am really motivated to do, is to disseminate empirically supported, evidence-based treatment for people with GI distress in a way that is accessible and affordable to as wide a range of people as possible. We need to be turning to technology and to novel ways of treatment to answer the incredible level of need."
The research team is currently enrolling patients for a clinical trial to test version 2.0 of the app, which will be pitted against a control app designed to reflect treatment as usual, sourced from publicly available materials like guidelines from the National Institutes of Health.
To access this paper (pre-print), please click here