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The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge

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: NCT04589520
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Ranjani Iyer, Heartfulness Institute

Study Description
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Brief Summary:

HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness. The study is conducted to examine the effect of the app on stress and emotional wellness in participants 14 years and older.

Research Question: Does HeartBot affect the stress levels and emotional wellness in participants 14 years and older?

Hypothesis: Participants who use HeartBot for 21 days will see a significant decrease in their stress levels and an improvement in emotional wellness.


Condition or disease Intervention/treatment Phase
Stress Mental Health Wellness 1 Behavioral: HeartBot App Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge
Actual Study Start Date : August 18, 2019
Actual Primary Completion Date : October 21, 2019
Actual Study Completion Date : October 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: HeartBot Group
The HeartBot group downloaded the app and used it daily for 21 days based on a calendar that provided them with step by step outlines of the tools for each day.
 Behavioral: HeartBot App
HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness to deal with daily stress and anxiety in a healthy, productive manner.
No Intervention: Control Group
The control group did not download the app and experienced no change to their daily routines.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Stress Levels [ Time Frame: 21 days for 30 minutes every day based on a 21-day calendar ]
    Participant stress levels were measured using the Perceived Stress Scale (PSS). This 10-item scale measures the degree to which a situation in someone's life is considered stressful .


Secondary Outcome Measures :
  1. Change in Emotional Wellbeing [ Time Frame: 21 days for 30 minutes every day based on a 21-day calendar ]
    The emotional wellness of the participants was measured using the EPOCH measure of adolescent wellbeing. This is a 20-item scale used to measure five different positive characteristics: Engagement, Perseverance, Optimism, Connectedness, and Happiness.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants 14 years of age and older willing to participate in the study; parental/guardian consent in case of the student below 18 years of age.

Exclusion Criteria:

  • Individuals less than 14 years of age. As the app is available on iOS only, you need to have an iOS device to participate.
Contacts and Locations
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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): NCT04589520


Locations
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United States, Michigan
Ranjani B Iyer
Novi, Michigan, United States, 48375
Sponsors and Collaborators
Ranjani Iyer
Investigators
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Principal Investigator: Ranjani B Iyer, PhD Heartfulness Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ranjani Iyer, Director of Heartfulness Program for Schools, Heartfulness Institute
ClinicalTrials.gov Identifier: NCT04589520    
Other Study ID Numbers: 2019/07/11
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publish a research paper with details on the study design, protocol, analysis of data, and report on implications to stress management and wellness tools.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Starting six months after publication
Access Criteria: Access criteria IPD and any additional supporting information will be shared with the researchers furthering research in stress management and emotional wellness tools.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No