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

NCT04589520 | Completed

• 1 other identifier: 2019/07/11
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Mental Health Wellness 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Emotional Wellbeing

  21 days for 30 minutes every day based on a 21-day calendar

Study Arms (2)

HeartBot Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The control group did not download the app and experienced no change to their daily routines.

Interventions

HeartBot App BEHAVIORAL

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.

HeartBot Group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ranjani Iyer: lead

Study Sites (1)

Ranjani B Iyer

Novi, Michigan, 48375, United States

Location

Related Publications (1)

• 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.

  PMID: 33455902 DERIVED

Study Officials

• Ranjani B Iyer, PhD

  Heartfulness Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Heartfulness Program for Schools

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: August 18, 2019
• Primary Completion: October 21, 2019
• Study Completion: October 31, 2019
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)