Clinical trial NCT04665271: Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS
Official title: Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: cognitive behavioral therapy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Bold Health Inc.
First posted: 2020-12-11
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Active control with cross-over at post-treatment and three month follow-up
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to assess if a new digital app version of a self-help intervention for Irritable Bowel Syndrome (IBS), is an acceptable and effective treatment for improving the overall quality of life in patients with IBS.

Detailed description: The aim of the current study is to test the acceptability and efficacy of an updated digital app for IBS patients. The design of the study is experimental. There will be two experimental groups, an immediate treatment group and an active control group. Once consented and enrolled, participants will be randomly assigned to either the immediate treatment group or the active control group by the coin toss feature of random.org. Participants in the immediate treatment group will be able to download the app at no cost. Participants in the control group will be given access to an education and relaxation training control app at no cost to them. At 8 weeks after enrollment, all participants in both groups will receive a battery of follow-up questionnaires (the same that they answered directly after consenting in the beginning of the study as baseline measures). Upon receipt of the 8 week questionnaire data, participants in the control group will be given access to the Zemedy app. After having had access to the app for 8 weeks, control participants will be asked to complete another set of questionnaires. All participants will receive 3 month post-treatment follow-up questionnaires. The research method is experimental, cross over (randomized controlled trial) with a control control. Participation in the study will last approximately 4.5 months, depending on the subjects willingness to participate and rate of completion.

Eligibility criteria: Inclusion Criteria:

* Self-report of physician diagnosis of IBS.
* At least 18 years of age.

Exclusion Criteria:

* Severe depression or suicidality
* Comorbid GI disorder such as inflammatory bowel disease or celiac disease.
* Pregnancy

Primary outcomes:
measure: Irritable Bowel Syndrome Quality of Life (IBSQoL)
timeFrame: 8 weeks
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 8 weeks
Secondary outcomes:
measure: GI-Cognitions Questionnaire (GICog)
timeFrame: 8 weeks
measure: Visceral Sensitivity Index (VSI)
timeFrame: 8 weeks
measure: Fear of Food Questionnaire (FFQ)
timeFrame: 8 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 8 weeks
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: Hunt MG, Dalvie A, Ipek S, Wasman B. Acceptability and efficacy of the Zemedy app versus a relaxation training and meditation app for IBS: protocol for a randomised controlled trial. BMJ Open. 2022 Jan 17;12(1):e055014. doi: 10.1136/bmjopen-2021-055014.