NCT05874232

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

April 4, 2023

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Heartfulness Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The control group had no change in their daily routines.

Interventions

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.

Heartfulness Group

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ranjani B Iyer

Novi, Michigan, 48375, United States

Location

Related Publications (1)

  • Iyer P, Iyer L, Carter N, Iyer R, Stirling A, Priya L, Sriraman U. Self-Care Program as a Tool for Alleviating Anxiety and Loneliness and Promoting Satisfaction With Life in High School Students and Staff: Randomized Survey Study. JMIR Form Res. 2024 Sep 30;8:e56355. doi: 10.2196/56355.

MeSH Terms

Conditions

Anxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2023

First Posted

May 24, 2023

Study Start

February 3, 2022

Primary Completion

June 3, 2022

Study Completion

July 3, 2022

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Publish a research paper with details on the study design, protocol, analysis of data, and report on implications to stress management and wellness tools.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Starting six months after publication
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.

Locations