Mental Health Wellness 1HEARTNCT04790162
Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program
A study testing Heartfulness Meditation in people with Mental Health Wellness 1 and Stress, Psychological, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Stress, Psychological, Depression
- What is being tested?
- Heartfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ages 20-70
- Student in one of the health care programs on the Anschutz Medical Campus at the University of Colorado.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz
Aurora, Colorado, 80045
Robyn Gisbert
About this study
Official title: Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program (HEART)
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.
Read the 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).
- Conditions
- Mental Health Wellness 1, Stress, Psychological, Depression, Anxiety
- Being tested
- Heartfulness Meditation
- Keywords
- Resiliency, Meditation, Health Care Student, Heartfulness
- Medical subject headings
- Stress, Psychological, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heartfulness MeditationBehavioural
Heartfulness meditation with a trainer provided virtually
| Study group | Role | What they receive |
|---|---|---|
| Meditation Intervention | Active comparator | Heartfulness meditation Receives: Behavioral: Heartfulness Meditation |
| Control | No intervention | Wait listed control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by the Number of Meditation Sessions Completed
Number of Meditation Sessions Completed-logged in RedCap
Measured: 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.
Measured: 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
Measured: 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
Measured: 45 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Sep 2021
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robyn Gisbert, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790162
- Sponsor's protocol ID
- 20-2951
- Acronym
- HEART
- Status last verified
- Aug 2022
- First submitted
- 4 Mar 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program (HEART)
- ClinicalTrials.gov ID
- NCT04790162
- Acronym / sponsor ID
- HEART / 20-2951
- Conditions
- Mental Health Wellness 1, Stress, Psychological, Depression, Anxiety
- Keywords
- Resiliency, Meditation, Health Care Student, Heartfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Meditation Intervention | Active comparator | Behavioral: Heartfulness MeditationHeartfulness meditation |
| Control | No intervention | –Wait listed control group |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women ages 20-70
- Student in one of the health care programs on the Anschutz Medical Campus at the University of Colorado.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heartfulness MeditationHeartfulness meditation with a trainer provided virtually | Behavioural | Meditation Intervention |
Primary outcome
Feasibility as measured by the Number of Meditation Sessions Completed
Time frame: 90 days
Number of Meditation Sessions Completed-logged in RedCap
Change in Resilience as measured by Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 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.
Change in Anxiety/Depression as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: 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
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ-8)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Gisbert principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heartfulness Meditation in people with Mental Health Wellness 1 and Stress, Psychological, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robyn Gisbert (3037249361, robyn.gisbert@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by the Number of Meditation Sessions Completed (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.