The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.

Anxiety Clinical Trial

Official title:

The Impact of Heartfulness Self-Care Program on Anxiety, Satisfaction With Life, and Loneliness Levels in Students and Staff in High Schools.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05874232
• Other study ID #: 2022/01/2
• Status: Completed
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: July 3, 2022

Study information

• Verified date: May 2023
• Source: Heartfulness Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This quantitative study assesses the baseline anxiety, satisfaction with life, and loneliness scores in students and staff in a global study. Assessments at baseline will include the GAD, SWLS, and UCLA loneliness scale, and the same questionnaires were collected in Week 4 and Week 8. The Google form questionnaire will ask the high schoolers and staff 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 aim of this study is to assess changes in scores measuring symptoms of anxiety using GAD-7 (and GAD-Child), Satisfaction with Life Scale (SWLS and SWLS-C), and UCLA Loneliness Scale (Version 3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

Inclusion Criteria:

• High School Students (grades 9-12) and Staff, aged 14 and above, and willing to participate in the study.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• 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 weekly 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 Anxiety	To assess the current level of anxiety in high school students and staff through GAD Scale.	Week 0
Primary	Changes level of Anxiety	To assess the beneficial impact of Heartfulness program on anxiety in high school students and staff.	Week 4 and Week 8
Primary	Assess the current level of Satisfaction with Life	To assess the current level of satisfaction with life in high school students and staff through SWLS Scale.	Week 0
Primary	Changes level of Satisfaction with Life	To assess the beneficial impact of Heartfulness program on satisfaction with life in high school students and staff.	Week 4 and Week 8
Primary	Assess the current level of Loneliness	To assess the current level of loneliness in high school students and staff through UCLA loneliness scale.	Week 0
Primary	Changes in Loneliness levels	To assess the beneficial impact of Heartfulness program on loneliness in high school students and staff.	Week 4 and Week 8