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Heartfulness Meditation for Mental Health Wellness (HEART Trial)
N/A
Waitlist Available
Led By Robyn Gisbert
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women ages 20-70
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days, 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if an online meditation program can help health care students become more resilient and reduce their anxiety and depression. Loving Kindness Meditation (LKM) is a systemized mind-body approach developed to increase loving acceptance and has previously been reported to increase resilience in the face of adversity.
Who is the study for?
This trial is for health care students aged 20-70 at the University of Colorado's Anschutz Medical Campus who are not already practicing meditation more than once a week and can use the required technology without special accommodations.
What is being tested?
The study tests if a virtual Heartfulness Meditation program over 90 days can improve resilience, depression, and anxiety in healthcare students. The ease of attending online sessions and their completion rates will also be assessed.
What are the potential side effects?
Heartfulness Meditation is generally considered safe with no significant physical side effects. However, some individuals may experience increased emotional sensitivity or discomfort when beginning any new mental wellness practice.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 45 days, 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days, 90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ-8)
Change in Anxiety/Depression as measured by the Hospital Anxiety and Depression Scale (HADS)
Change in Resilience as measured by Connor-Davidson Resilience Scale (CD-RISC)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Meditation InterventionActive Control1 Intervention
Heartfulness meditation
Group II: ControlActive Control1 Intervention
Wait listed control group
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include pharmacological approaches like antidepressants and non-pharmacological methods such as cognitive-behavioral therapy (CBT) and mindfulness-based interventions. Antidepressants, such as SSRIs and SNRIs, work by altering neurotransmitter levels in the brain, which can help improve mood and emotional regulation.
CBT focuses on changing negative thought patterns and behaviors, thereby reducing depressive symptoms. Mindfulness-based interventions, including meditation practices like those in the Heartfulness Practice trial, aim to increase awareness and acceptance of present-moment experiences, which can reduce stress and improve emotional resilience.
These mechanisms are crucial for depression patients as they offer multiple pathways to alleviate symptoms, enhance coping strategies, and improve overall mental health.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,822,149 Total Patients Enrolled
13 Trials studying Depression
5,968 Patients Enrolled for Depression
Robyn GisbertPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- A student who is enrolled in one of the health care programs at the Anschutz Medical Campus at the University of Colorado.I regularly practice meditation, such as Transcendental Meditation or MBSR, more than once a week.I am between 20 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Meditation Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04790162 — N/A