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Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS

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ClinicalTrials.gov Identifier: NCT04665271
Recruitment Status : Not yet recruiting
First Posted : December 11, 2020
Last Update Posted : February 2, 2021
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 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Active control with cross-over at post-treatment and three month follow-up
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptability and Efficacy of Zemedy App Versus Education and Relaxation Training App for IBS
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : February 16, 2023
Estimated Study Completion Date : May 28, 2023

Arm Intervention/treatment
Experimental: Immediate Treatment - Zemedy App
Participants will be given immediate access to the Zemedy app for IBS.
Behavioral: Zemedy App
Digital smart phone app that delivers cognitive-behavioral therapy for IBS

Active Comparator: Active Control - Education and Relaxation Training App
Participants will be given access to a education and relaxation training app. After 8 weeks they will then be crossed over to the Zemedy app.
Behavioral: Zemedy App
Digital smart phone app that delivers cognitive-behavioral therapy for IBS




Primary Outcome Measures :
  1. Irritable Bowel Syndrome Quality of Life (IBSQoL) [ Time Frame: 8 weeks ]
    IBS specific health related quality of life measure. Scale scores range from 0-100 with higher scores reflecting more impairment (worse outcome)

  2. Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: 8 weeks ]
    Gastrointestinal Symptom Rating Scale. Scale scores range from 0-78 with high scores representing worse GI symptoms.


Secondary Outcome Measures :
  1. GI-Cognitions Questionnaire (GICog) [ Time Frame: 8 weeks ]
    Scale measures distorted, catastrophic beliefs about the social and occupational implications of having gastrointestinal symptoms. Scale scores range from 0 to 64 with higher scores representing worse outcomes (more distorted, catastrophic beliefs about GI symptoms)

  2. Visceral Sensitivity Index (VSI) [ Time Frame: 8 weeks ]
    Scale measures anxiety about visceral (gut) sensations. Scale scores range from 0 to 75 with higher scores representing more anxiety.

  3. Fear of Food Questionnaire (FFQ) [ Time Frame: 8 weeks ]
    Scale measures fear of food and aversive consequences of eating. Scale scores range from 0-90 with higher scores representing more fear and impairment.

  4. Beck Depression Inventory (BDI) [ Time Frame: 8 weeks ]
    Measures depressive symptoms. Scale scores range from 0 to 63 with higher scores representing more severe depressive symptoms.

  5. Work Productivity and Activity Impairment (WPAI) [ Time Frame: 8 weeks ]
    Measures occupational impairment stemming from a health condition. scores range from 0 to 30 with higher scores representing more impairment



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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:

  • 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

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): NCT04665271


Contacts
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Contact: Melissa G Hunt, PhD 6105298055 mhunt@psych.upenn.edu
Contact: Anika Dalvie 925-389-0722 asdalvie@sas.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6018
Sponsors and Collaborators
University of Pennsylvania
Bold Health
  Study Documents (Full-Text)

Documents provided by Melissa Hunt, PhD, University of Pennsylvania:
Informed Consent Form  [PDF] January 14, 2021
Study Protocol  [PDF] January 14, 2021

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Responsible Party: Melissa Hunt, PhD, Associate Director of Clinical Training, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04665271    
Other Study ID Numbers: 844160
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
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
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases