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Trial record 1 of 1 for:    zemedy
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Acceptability and Efficacy of the Zemedy App for IBS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04170686
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
Bold Health
Information provided by (Responsible Party):
Melissa Hunt, PhD, University of Pennsylvania

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: Zemedy App for IBS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of IBS. Own a smart phone. Speak English

Exclusion Criteria:

  • Under age of consent (18) Diagnosed with another GI disorder (e.g. celiac disease, inflammatory bowel disease)

Information from the National Library of Medicine

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


Contacts
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Contact: Melissa G Hunt, PhD 12158986478 mhunt@psych.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-6018
Contact: Melissa G Hunt    215-898-6478    mhunt@psych.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Bold Health
Investigators
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Principal Investigator: Melissa G Hunt, PhD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Melissa Hunt, PhD, University of Pennsylvania:

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Responsible Party: Melissa Hunt, PhD, Associate Director of Clinical Training, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04170686    
Other Study ID Numbers: 833848
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melissa Hunt, PhD, University of Pennsylvania:
cognitive behavioral therapy
self-help
irritable bowel syndrome
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases