Acceptability and Efficacy of the Zemedy App for IBS
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|ClinicalTrials.gov Identifier: NCT04170686|
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Behavioral: Zemedy App for IBS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acceptability and Efficacy of the Zemedy App for IBS|
|Actual Study Start Date :||October 28, 2019|
|Estimated Primary Completion Date :||October 28, 2020|
|Estimated Study Completion Date :||October 28, 2020|
Experimental: Immediate Treatment
Participants will have immediate access to the self-help app. They will take 8 weeks to work through the content at their own pace.
Behavioral: Zemedy App for IBS
The Zemedy App for IBS is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS.
No Intervention: Waitlist Control
Participants in the waitlist will receive no intervention for 8 weeks, other than a few "check in" emails from study personnel. At the end of 8 weeks, they will be crossed over to the active treatment group and will be given access to the app.
- Irritable Bowel Syndrome Quality of LIfe [ Time Frame: 8 weeks ]A self-report measure of HRQL in people with IBS. Scores range from 0 to 100. Higher scores are a worse outcome.
- Gastrointestinal Symptom Rating Scale [ Time Frame: 8 weeks ]a self-report measure of GI symptom severity. Scores range from 0 to 78. Higher scores are a worse outcome.
- Visceral Sensitivity Index [ Time Frame: 8 weeks ]self-report measure of anxiety specific to visceral sensations. Scores range from 0 to 75. Higher scores are a worse outcome.
- GI Cognitions Questionnaire [ Time Frame: 8 weeks ]self-report measure of catastrophizing specific to GI symptoms. Scores range from 0 to 64. Higher scores are a worse outcome.
- Fear of Food Questionnaire [ Time Frame: 8 weeks ]self-report measure of fear of food. Scores range from 0 to 90. Higher scores are a worse outcome.
- Patient Health Questionnaire [ Time Frame: 8 weeks ]self-report measure of depressive symptoms. Scores range from 0 to 27. Higher scores are a worse outcome.
- Depression and Anxiety Stress Scales [ Time Frame: 8 weeks ]self-report measure of depressive and anxious symptoms. scores ranges from 0 to 126. Higher scores are a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170686
|Contact: Melissa G Hunt, PhDemail@example.com|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104-6018|
|Contact: Melissa G Hunt 215-898-6478 firstname.lastname@example.org|
|Principal Investigator:||Melissa G Hunt, PhD||University of Pennsylvania|