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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT04790162
Collaborator
(none)
150
1
2
31
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Heartfulness Meditation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
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.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)
Primary Purpose:
Other
Official Title:
Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program (HEART)
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Meditation Intervention

Heartfulness meditation

Behavioral: Heartfulness Meditation
Heartfulness meditation with a trainer provided virtually

No Intervention: Control

Wait listed control group

Outcome Measures

Primary Outcome Measures

  1. Feasibility as measured by the Number of Meditation Sessions Completed [90 days]

    Number of Meditation Sessions Completed-logged in RedCap

  2. 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.

  3. 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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Anschutz Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

  • Principal Investigator: Robyn Gisbert, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT04790162
Other Study ID Numbers:
  • 20-2951
First Posted:
Mar 10, 2021
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022