Clinical trial NCT04790162: Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program
Official title: Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program (HEART)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Wellness 1
Stress, Psychological
Depression
Anxiety
Keywords: Resiliency
Meditation
Health Care Student
Heartfulness
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as measured by the Number of Meditation Sessions Completed
timeFrame: 90 days
measure: Change in Resilience as measured by Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Baseline, 45 days, 90 days
measure: Change in Anxiety/Depression as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 45 days, 90 days
measure: Acceptability as measured by the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 45 days, 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Robyn Gisbert
role: PRINCIPAL_INVESTIGATOR
References: