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

Study Overview
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Brief Summary
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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
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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).

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

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

Intervention / Treatment
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* Behavioral: Heartfulness Meditation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a randomized mixed methods (i.e., quantitative and qualitative methodology) intervention study with an experimental meditation group (HEART) and a wait-listed control group (CON). The wait-listed group will be offered the meditation after the 90-day data point.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meditation Intervention<br>Heartfulness meditation | Behavioral: Heartfulness Meditation<br>* Heartfulness meditation with a trainer provided virtually<br>|
| No Intervention: Control<br>Wait listed control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by the Number of Meditation Sessions Completed | Number of Meditation Sessions Completed-logged in RedCap | 90 days | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resiliency, Meditation, Health Care Student, Heartfulness