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

Not Applicable

• Conditions: Mental Health Wellness 1; Depression; Stress, Psychological; Anxiety
• Interventions: Behavioral: Heartfulness Meditation

• Registration Number: NCT04790162
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-10
• Study Start: 2021-09-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-16
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meditation Intervention	Heartfulness Meditation	Heartfulness meditation

Primary Outcome Measures

Name	Time	Method
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ-8)	45 days, 90 days	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
Change in Resilience as measured by Connor-Davidson Resilience Scale (CD-RISC)	Baseline, 45 days, 90 days	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.
Change in Anxiety/Depression as measured by the Hospital Anxiety and Depression Scale (HADS)	Baseline, 45 days, 90 days	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
Feasibility as measured by the Number of Meditation Sessions Completed	90 days	Number of Meditation Sessions Completed-logged in RedCap

Trial Locations

Locations (1)

University of Colorado Anschutz; 🇺🇸 Aurora, Colorado, United States