What side effects are associated with this type of intervention?

Mindfulness-based therapies for depression, such as Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR), are generally well-tolerated with minimal side effects, primarily involving temporary discomfort from increased awareness of negative emotions or physical sensations. In contrast, pharmacological treatments like SSRIs, SNRIs, and tricyclic antidepressants often have more pronounced side effects, including nausea, weight gain, sexual dysfunction, insomnia, and increased anxiety. Therefore, mindfulness practices offer a favorable side effect profile compared to traditional pharmacotherapy.

What prior FDA approvals exist?

The FDA has approved several antidepressants for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like escitalopram and duloxetine. These medications have shown efficacy in clinical trials, with escitalopram demonstrating a significant reduction in depressive symptoms. Additionally, while not FDA-approved specifically for depression, mindfulness and meditation practices, such as those studied in the Heartfulness Practice trial, have been explored for their potential benefits in improving mental health and resilience. These non-pharmacological approaches are generally considered safe and may complement traditional pharmacotherapy.

What other types of research exist?

Promising alternatives to Heartfulness Practice for depression patients include: 1) Mindfulness-Based Cognitive Therapy (MBCT), which has shown effectiveness in reducing psychological distress and improving quality of life. 2) Cognitive Behavioral Therapy (CBT), particularly tailored for cancer survivors, which has demonstrated efficacy in managing distress and pain. 3) Guided Imagery and Progressive Muscle Relaxation, which have been effective in reducing pain and improving mental health outcomes in cancer patients. 4) Yoga and Tai Chi, which have been beneficial for psychosocial well-being and stress reduction. 5) Biofeedback and relaxation-response training, which are useful for managing stress and improving mental health in pediatric and adult populations.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 days, 90 days for reporting.

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 more

Awards & 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

0 / 1Eligibility criteria met

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.