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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Mental Health Wellness 1
• Intervention / Treatment: Behavioral: HeartBot App

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Novi, Michigan, United States, 48375
      • Ranjani B Iyer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress Levels	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 .	21 days for 30 minutes every day based on a 21-day calendar

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Emotional Wellbeing	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.	21 days for 30 minutes every day based on a 21-day calendar

Collaborators and Investigators

• Sponsor: Ranjani Iyer
• Investigators: Principal Investigator: Ranjani B Iyer, PhD, Heartfulness Institute

Publications and helpful links

General Publications

• Iyer L, Iyer RB, Kumar V. A Relaxation App (HeartBot) for Stress and Emotional Well-Being Over a 21-Day Challenge: Randomized Survey Study. JMIR Form Res. 2021 Jan 29;5(1):e22041. doi: 10.2196/22041.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2019
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019/07/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Time Frame: Starting six months after publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No