The Impact of Heartfulness Program on Loneliness in High School Students in the US

This quantitative study assesses the baseline loneliness scores in all the high school students in the US. Assessments at baseline will include the UCLA loneliness scale. The Google form questionnaire will ask the high schoolers for their email address and their parent's email address (if they are under 18). The form will also include a question eliciting interest in participation in the 4-weeks Heartfulness program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.

Study Overview

• Status: Completed
• Conditions: Loneliness
• Intervention / Treatment: Behavioral: Self-Care Program through Heartfulness

Detailed Description

The specific aims of the study are:

1. To assess the current level of loneliness in high school students through the UCLA loneliness scale.
2. To assess the beneficial impact of the Heartfulness program on loneliness in high school students in the US.

• Study Type: Interventional
• Enrollment (Actual): 108
• 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: 10 years to 15 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants are High School students in the US and willing to participate in the study

Exclusion Criteria:

• Non-English speaking high school students in the US and those with mental health diagnoses such as Major Depressive Disorder and Anxiety disorders.

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: Heartfulness Group; Participants were asked to practice relaxation tools for 15 minutes a day using the calendar and HeartBot app, and participate in once a week webinar for 30 minutes during the four weeks. UCLA Loneliness scale was recorded prior to the start of the study and at its end after the duration of 4 weeks. The score was reviewed to see the changes in the loneliness scale.	Behavioral: Self-Care Program through Heartfulness; A four-week Self-Care program through Heartfulness will be offered to participants in the Heartfulness group. This would include a daily practice of relaxation tools for 15 minutes a day using an app and once a week webinar for 30 minutes. Guided relaxation and meditation sessions will be offered to the participants during the intervention weeks. These virtual sessions were conducted by Heartfulness Champions and certified trainers from Heartfulness Institute.
No Intervention: Control Group; The control group had no change in their daily routines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the current level of Loneliness	To assess the current level of loneliness in high school students through UCLA loneliness scale.	Baseline data through the pre-UCLA survey scores
Changes in Loneliness levels	To assess the beneficial impact of Heartfulness program on loneliness in high school students in the US.	28 days for 15 minutes every day based on a 28-day calendar

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): July 28, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020/05/8

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