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

Loneliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602455
• Other study ID #: 2020/05/8
• Status: Completed
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: October 2020
• Source: Heartfulness Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 15, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Loneliness

Intervention

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.

Locations

Country	Name	City	State
United States	Ranjani B Iyer	Novi	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Heartfulness Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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