Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04170686
Recruitment Status : Completed
First Posted : November 20, 2019
Results First Posted : December 24, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
Bold Health Inc.
Information provided by (Responsible Party):
Melissa Hunt, PhD, University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE November 14, 2019
First Posted Date  ICMJE November 20, 2019
Results First Submitted Date  ICMJE October 26, 2020
Results First Posted Date  ICMJE December 24, 2020
Last Update Posted Date February 16, 2021
Actual Study Start Date  ICMJE October 28, 2019
Actual Primary Completion Date September 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • Irritable Bowel Syndrome Quality of Life [ Time Frame: 8 weeks ]
    A self-report measure of health related quality of life (HRQL) in people with irritable bowel syndrome. 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • 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 Anxiety and Stress Scale - Depression Subscale [ Time Frame: 8 weeks ]
    Self-report measure of depressive symptoms. Scores ranges from 0 to 42. Higher scores represent worse outcome.
  • Depression Anxiety and Stress Scale - Stress Subscale [ Time Frame: 8 weeks ]
    The stress subscale measures emotional reactivity to perceived stress. Scores range from 0-42 with higher scores representing worse stress reactivity.
  • Depression Anxiety and Stress Scale - Anxiety Subscale [ Time Frame: 8 weeks ]
    Measures affective and physical symptoms of anxiety. Scores range from 0-42 with higher scores representing worse anxiety.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
Official Title  ICMJE Acceptability and Efficacy of the Zemedy App for Irritable Bowel Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE Behavioral: Zemedy App for Irritable Bowel Syndrome
The Zemedy App for irritable bowel syndrome 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Zemedy App for Irritable Bowel Syndrome
  • 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.
Publications * Hunt M, Miguez S, Dukas B, Onwude O, White S. Efficacy of Zemedy, a Mobile Digital Therapeutic for the Self-management of Irritable Bowel Syndrome: Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 May 20;9(5):e26152. doi: 10.2196/26152.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2020)
146
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2019)
120
Actual Study Completion Date  ICMJE September 28, 2020
Actual Primary Completion Date September 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04170686
Other Study ID Numbers  ICMJE 833848
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Melissa Hunt, PhD, University of Pennsylvania
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bold Health Inc.
Investigators  ICMJE
Principal Investigator: Melissa G Hunt, PhD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP