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

Sponsor
Ranjani Iyer (Other)
Overall Status
Completed
CT.gov ID
NCT04589520
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
2.4
Actual Duration (Months)
36.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: HeartBot App
 N/A

Study Design

Study Type:
Interventional
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 :
Aug 18, 2019
Actual Primary Completion Date :
Oct 21, 2019
Actual Study Completion Date :
Oct 31, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. Change in Stress Levels [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 [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

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Ranjani B Iyer Novi Michigan United States 48375

Sponsors and Collaborators

  • Ranjani Iyer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Oct 19, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 19, 2020