NCT04790162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

2.6 years

First QC Date

March 4, 2021

Last Update Submit

August 12, 2022

Conditions

Keywords

ResiliencyMeditationHealth Care StudentHeartfulness

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Meditation Intervention

ACTIVE COMPARATOR

Heartfulness meditation

Behavioral: Heartfulness Meditation

Control

NO INTERVENTION

Wait listed control group

Interventions

Heartfulness meditation with a trainer provided virtually

Meditation Intervention

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ages 20-70
  • Student in one of the health care programs on the Anschutz Medical Campus at the University of Colorado.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Robyn Gisbert

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 10, 2021

Study Start

September 1, 2021

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations