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

Sponsor

Heartfulness Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04602455

Collaborator

(none)

108

Enrollment

Location

Arms

1.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Loneliness	Behavioral: Self-Care Program through Heartfulness	N/A

Detailed Description

The specific aims of the study are:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 23, 2020

Actual Primary Completion Date :

Jul 28, 2020

Actual Study Completion Date :

Aug 15, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Heartfulness Institute

Investigators

Principal Investigator: Ranjani B Iyer, PhD, Heartfulness Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heartfulness Institute

ClinicalTrials.gov Identifier:

NCT04602455

Other Study ID Numbers:

2020/05/8

First Posted:

Oct 26, 2020

Last Update Posted:

Oct 26, 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:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 26, 2020