Behavioral Digital Therapeutics in Gastrointestinal Conditions

Greywoode, Ruby; Szigethy, Eva

doi:10.1016/j.gtc.2022.07.011

Cited by 4 publications

(4 citation statements)

References 30 publications

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“…The use of digital health apps has grown, and mobile phones are ubiquitous in the United States with 90% of the population owning a smartphone ( 44 ). Developing health apps to administer cost-effective care on a wide scale can mitigate challenges to access and improve patient outcomes ( 45 , 46 ).…”

Section: Discussionmentioning

confidence: 99%

Acute and Long-Term Effects of App-Delivered Heartfulness Meditation on Psychological Outcomes and the Endocannabinoid Signaling System in Cyclic Vomiting Syndrome

Venkatesan,

Hillard,

Ayer

et al. 2024

Clin Transl Gastroenterol

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Background: Cyclic vomiting syndrome (CVS) is a disorder of gut brain interaction (DGBI) often triggered by stress. Interventions like meditation may improve psychological outcomes and Health-Related Quality of Life (HRQoL), but their efficacy and the underlying mechanism are unknown. Methods: We conducted a 6-week single-arm pilot study to assess the effects of Heartfulness meditation (HFM) in CVS using a custom-designed meditation app. Primary outcomes included state and trait anxiety and mood state changes pre- vs. post-meditation, and secondary outcomes were psychological distress, coping, sleep quality and HRQoL at baseline and weeks 3 and 6. Serum concentrations of endocannabinoids N-arachidonylethanolamine (AEA) and 2-arachidonoylglycerol (2-AG) and related lipids were measured pre-and-post HFM at baseline and week 6. Results: In 30 treatment completers, there was a significant improvement in state anxiety (p<0.001), total mood disturbance (p<0.001), and other mood states (all p values <0.05) across the three time points. Trait anxiety was also improved at week 6. There was a significant improvement in psychological distress (global severity index), sleep quality (daytime dysfunction), coping (using religion/spirituality) and HRQoL (mental and physical) across the three time points (all p <0.05). Significant increases in AEA and related lipids N-oleoylethanolamine and palmitoylethanolamide post-vs.-pre HFM were observed at week 6 (p<0.001, 0.002, 0.003, respectively). No adverse effects were noted. Discussion: App-delivered HFM is feasible, safe and effective and improves psychological outcomes and augments endocannabinoids. This provides insight into the mechanism underlying HFM and has potential for widespread use as a digital therapeutic in CVS and other DGBI. Study Highlights

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Section: Discussionmentioning

confidence: 99%

Acute and Long-Term Effects of App-Delivered Heartfulness Meditation on Psychological Outcomes and the Endocannabinoid Signaling System in Cyclic Vomiting Syndrome

Venkatesan,

Hillard,

Ayer

et al. 2024

Clin Transl Gastroenterol

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“…Digital methods of treatment delivery, such as websites and mobile phone apps, could be powerful tools for treatment of gastrointestinal and psychological symptoms in people with IBS 133 . They can also be leveraged to offset limited access to integrated services.…”

Section: Guidelines For Use Of Digital Toolsmentioning

confidence: 99%

“…With regard to psychological interventions, clinicians must be attuned to the patient characteristics that lend themselves to low-intensity interventions: mild (to moderate) disease severity; high insight into the gut–brain axis and the multifactorial aspect of IBS (for example, the clinician has credibly conveyed the role of BGBT); the absence of severe comorbid depression or anxiety disorder, as this scenario requires an individualized approach under the supervision of a mental health practitioner; the presence of a specific gastrointestinal symptom (for example, chronic pain or vomiting) or comorbidity (for example, fibromyalgia or chronic fatigue syndrome); and an understanding that if a digital therapy does not reduce the patient’s symptoms, the class of therapy has not failed but more personalized intervention is needed. In addition, the risk associated with some therapies is higher when they are not delivered by a qualified clinician 133 . For example, hypnotherapy is not safe for all patients, and a qualified clinician would not offer it if screening identified risks, such as history of dissociation or substantial trauma.…”

Section: Guidelines For Use Of Digital Toolsmentioning

confidence: 99%

Irritable bowel syndrome and mental health comorbidity — approach to multidisciplinary management

Staudacher

Black

Teasdale

et al. 2023

Nat Rev Gastroenterol Hepatol

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Irritable bowel syndrome (IBS) affects 5–10% of the global population. Up to one-third of people with IBS also experience anxiety or depression. Gastrointestinal and psychological symptoms both drive health-care use in people with IBS, but psychological comorbidity seems to be more important for long-term quality of life. An integrated care approach that addresses gastrointestinal symptoms with nutrition and brain–gut behaviour therapies is considered the gold standard. However, best practice for the treatment of individuals with IBS who have a comorbid psychological condition is unclear. Given the rising prevalence of mental health disorders, discussion of the challenges of implementing therapy for people with IBS and anxiety and depression is critical. In this Review, we draw upon our expertise in gastroenterology, nutrition science and psychology to highlight common challenges that arise when managing patients with IBS and co-occurring anxiety and depression, and provide recommendations for tailoring clinical assessment and treatment. We provide best practice recommendations, including dietary and behavioural interventions that could be applied by non-specialists and clinicians working outside an integrated care model.

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“…From the initial idea of digitalizing CBT, DTx have evolved and continue to expand the range of embedded digital interventions and targeted areas. In Table 1 we compiled a nonexhaustive list of references across a variety of indications where DTx are currently developed, used or foreseen to play a key role for patients 2–41 . This illustrates why their development is associated with significant promise, in particular for tackling the continuously growing burden of chronic diseases 42 …”

Section: Category Target References Comment Type Publication Yearmentioning

confidence: 99%

Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology

Ribba,

Peck,

Hutchinson

et al. 2023

Clin Pharma and Therapeutics

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The promise of transforming digital technologies into treatments is what drives the development of digital therapeutics (DTx), generally known as software applications embedded within accessible technologies—such as smartphones—to treat, manage, or prevent a pathological condition. Whereas DTx solutions that successfully demonstrate effectiveness and safety could drastically improve the life of patients in multiple therapeutic areas, there is a general consensus that generating therapeutic evidence for DTx presents challenges and open questions. We believe there are three main areas where the application of clinical pharmacology principles from the drug development field could benefit DTx development: the characterization of the mechanism of action, the optimization of the intervention, and, finally, its dosing. We reviewed DTx studies to explore how the field is approaching these topics and to better characterize the challenges associated with them. This leads us to emphasize the role that the application of clinical pharmacology principles could play in the development of DTx and to advocate for a development approach that merges such principles from development of traditional therapeutics with important considerations from the highly attractive and fast‐paced world of digital solutions.

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Behavioral Digital Therapeutics in Gastrointestinal Conditions

Cited by 4 publications

References 30 publications

Acute and Long-Term Effects of App-Delivered Heartfulness Meditation on Psychological Outcomes and the Endocannabinoid Signaling System in Cyclic Vomiting Syndrome

Acute and Long-Term Effects of App-Delivered Heartfulness Meditation on Psychological Outcomes and the Endocannabinoid Signaling System in Cyclic Vomiting Syndrome

Irritable bowel syndrome and mental health comorbidity — approach to multidisciplinary management

Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology

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