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

NCT ID: NCT04790162

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-04-30

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).

Conditions

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Mental Health Wellness 1 Stress, Psychological Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Meditation Intervention

Heartfulness meditation

Group Type ACTIVE_COMPARATOR

Heartfulness Meditation

Intervention Type BEHAVIORAL

Heartfulness meditation with a trainer provided virtually

Control

Wait listed control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Heartfulness Meditation

Heartfulness meditation with a trainer provided virtually

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robyn Gisbert

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robyn Gisbert

Role: CONTACT

3037249361

Facility Contacts

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Robyn Gisbert

Role: primary

Other Identifiers

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20-2951

Identifier Type: -

Identifier Source: org_study_id

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