Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial
Notice bibliographique
Résumé
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
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».