Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program

Depression Clinical Trial

— HEART  

Official title:

Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program (HEART)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04790162
• Other study ID #: 20-2951
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 2024

Study information

• Verified date: August 2022
• Source: University of Colorado, Denver
• Contact: Robyn Gisbert
• Phone: 3037249361
• Email: robyn.gisbert[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day Heartfulness Practice delivered virtually for health care students. It is hypothesized that by providing this program on-line, students will be able to attend easily and complete the sessions. It is also hypothesized that those students who participate in the meditation program will increase resilience.

Description:

This investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day Heartfulness Practice delivered virtually for health care students.

SPECIFIC AIMS (SA) SA1: Determine feasibility and acceptability of delivering the 90-day Heartfulness Meditation Program virtually. Feasibility will be assessed by participant compliance, retention, and acceptability to the participants.

Criteria: Feasibility will be achieved by Compliance with average of at least 3 trainer led meditations / week Retention of 75% of participants at the end of 45 days (intermediate point) and 90 days (primary end point).

Criterion: Acceptability will be indicated by a CSQ8 score > 17. SA2: Examine the benefits of Heartfulness meditation on improving resilience, decreasing depression, and decreasing anxiety of health care students.

H2: At the end of 90 days (primary end point), students who participate in the Heartfulness Resilience Training (HEART) will have better resilience (CD-RISC) compared with students who do not participate and will have less anxiety and depression (HADS).

SA3: Examine the association between the number of sessions completed and changes in resilience, depression, and anxiety at 45 and 90 (primary end point) days.

H3: Changes in resilience, depression, and anxiety will be significantly correlated (Pearson correlation coefficients) with total number of sessions completed (H3a) and with number of one-on-one sessions with a trainer (H3b).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Men and women ages 20-70

• Student in one of the health care programs on the Anschutz Medical Campus at the University of Colorado.

Exclusion Criteria:

• Students who are currently engaged in any formal meditation practice (e.g., Transcendental Meditation, Mindfulness Based Stress Reduction, (MBSR) more than once per week

• Unable to use the technology without special accommodations.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Mental Health Wellness 1
• Stress, Psychological

Intervention

Behavioral:
• Heartfulness Meditation
Heartfulness meditation with a trainer provided virtually

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as measured by the Number of Meditation Sessions Completed	Number of Meditation Sessions Completed-logged in RedCap	90 days
Primary	Change in Resilience as measured by Connor-Davidson Resilience Scale (CD-RISC)	25 item self-report questionnaire developed to quantify resilience and the impact of psychoeducation and resilience therapy techniques. Total scores range from 0-100 with higher scores indicating greater levels of resilience. The CD-RISC has been used in a variety of populations.	Baseline, 45 days, 90 days
Primary	Change in Anxiety/Depression as measured by the Hospital Anxiety and Depression Scale (HADS)	14-item screening scale developed to indicate the potential presence of anxiety and depression. HADS consists of a 7-item anxiety subscale and a 7-item depression subscale. The HADS has good validity and reliability and has been studied in a variety of populations	Baseline, 45 days, 90 days
Primary	Acceptability as measured by the Client Satisfaction Questionnaire (CSQ-8)	8-item measure of satisfaction that is rated on a 4-point Likert scale and has a score range from 8 to 32. Higher scores indicate greater levels of satisfaction. For this study, we will assign 3 levels of satisfaction: 1) dissatisfied or least satisfied (score 8-16); 2) satisfied (score 17-30); and 3) very satisfied (score 31-32)The CSQ-8 has good test-retest reliability, internal consistency and sensitivity to treatment	45 days, 90 days