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

Primary Purpose

Mental Health Wellness 1, Stress, Psychological, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heartfulness Meditation
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Health Wellness 1 focused on measuring Resiliency, Meditation, Health Care Student, Heartfulness

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado AnschutzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Meditation Intervention

Control

Arm Description

Heartfulness meditation

Wait listed control group

Outcomes

Primary Outcome Measures

Feasibility as measured by the Number of Meditation Sessions Completed
Number of Meditation Sessions Completed-logged in RedCap
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
March 4, 2021
Last Updated
August 12, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04790162
Brief Title
Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program
Acronym
HEART
Official Title
Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program (HEART)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1, Stress, Psychological, Depression, Anxiety
Keywords
Resiliency, Meditation, Health Care Student, Heartfulness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meditation Intervention
Arm Type
Active Comparator
Arm Description
Heartfulness meditation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Wait listed control group
Intervention Type
Behavioral
Intervention Name(s)
Heartfulness Meditation
Intervention Description
Heartfulness meditation with a trainer provided virtually
Primary Outcome Measure Information:
Title
Feasibility as measured by the Number of Meditation Sessions Completed
Description
Number of Meditation Sessions Completed-logged in RedCap
Time Frame
90 days
Title
Change in Resilience as measured by Connor-Davidson Resilience Scale (CD-RISC)
Description
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.
Time Frame
Baseline, 45 days, 90 days
Title
Change in Anxiety/Depression as measured by the Hospital Anxiety and Depression Scale (HADS)
Description
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
Time Frame
Baseline, 45 days, 90 days
Title
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ-8)
Description
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
Time Frame
45 days, 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robyn Gisbert
Phone
3037249361
Email
robyn.gisbert@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Gisbert
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robyn Gisbert

12. IPD Sharing Statement

Plan to Share IPD
No

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

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