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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Loneliness; Satisfaction With Life
• Intervention / Treatment: Behavioral: Self-Care Program through Heartfulness

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 203
• 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: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

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
No Intervention: Control Group; The control group had no change in their daily routines.
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 weekly webinar for 30 minutes during the four weeks. The GAD, SWLS, and UCLA Loneliness scale was recorded prior to the start of the study, at the end of the program at Week 4, and after the duration of 4 weeks at Week 8. The score was reviewed to see the changes in anxiety, satisfaction with life, and 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the current level of Anxiety	To assess the current level of anxiety in high school students and staff through GAD Scale.	Week 0
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Heartfulness Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): June 3, 2022
• Study Completion (Actual): July 3, 2022

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022/01/2

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; SAP; 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