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

NCT04602455 | Completed

• 1 other identifier: 2020/05/8
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness

Outcome Measures

Primary Outcomes (2)

• 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

• 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

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 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

Control Group

NO INTERVENTION

The control group had no change in their daily routines.

Interventions

Self-Care Program through Heartfulness BEHAVIORAL

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.

Heartfulness Group

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants are High School students in the US and willing to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• Heartfulness Institute: lead

Study Sites (1)

Ranjani B Iyer

Novi, Michigan, 48375, United States

Location

Study Officials

• Ranjani B Iyer, PhD

  Heartfulness Institute

  PRINCIPAL INVESTIGATOR

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: October 21, 2020
• First Posted: October 26, 2020
• Study Start: June 23, 2020
• Primary Completion: July 28, 2020
• Study Completion: August 15, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• 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

US (1)