Meditation for Depression

Overseen By Tony T Yang, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: SSRIs

Must not be taking: Psychotropic medications

Disqualifiers: Pregnancy, Psychosis, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how mindfulness meditation affects brain connectivity and depression in teens. The goal is to see if meditation can strengthen brain areas that help regulate emotions and reduce depression symptoms. Teens will practice meditation, and researchers will measure changes in their brain and mood. The program uses a framework drawn from neuroscience, mindfulness, yoga, and modern psychotherapeutic techniques to promote emotional health.

Will I have to stop taking my current medications?

If you are taking any psychotropic medication other than one of the first-line SSRI antidepressants (like fluoxetine, escitalopram, or sertraline), you will need to stop those medications to participate in the study.

What data supports the effectiveness of the treatment Meditation for Depression?

Research shows that mindfulness training can reduce symptoms of depression, prevent relapse, and improve overall mental health. Mindfulness-based interventions have been effective for various psychiatric conditions, and social factors like group support also play a significant role in improving depression and stress. ^{1 2 3 4 5}

Is mindfulness meditation safe for treating depression?

Mindfulness meditation, including Mindfulness-Based Cognitive Therapy (MBCT), is generally considered safe for treating depression. Studies show it is delivered effectively and safely in real-world healthcare settings, with a low rate of negative effects comparable to other therapies. ^{1 2 4 6 7}

How is the TARA treatment different from other treatments for depression?

TARA (Training for Awareness, Resilience, and Action) is unique because it specifically targets brain pathways involved in depression, making it potentially more effective for young people. Unlike standard treatments, it focuses on building awareness and resilience through group sessions, which may help reduce relapse rates. ^{2 8 9 10 11}

Research Team

Tony T Yang, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for teens aged 14-18 with depression, who are under a healthcare provider's care and can use Zoom for remote participation. They must not have significant medical or mental health conditions other than depression or anxiety, not be on certain medications, without MRI contraindications like metal implants, and not currently practicing mindfulness.

Inclusion Criteria

I am a teenager aged 14-18 with depression.

I am currently seeing a doctor or a mental health professional.

I have depression and an anxiety disorder.

Exclusion Criteria

Any other factors preventing from participation according to the judgment of the Principal Investigators.

MRI contraindications (metallic objects on or inside the body, e.g., braces), some types of tatoos, and pregnancy

Pregnancy or any plans to become pregnant during the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)

12 weeks

Follow-up

Participants are monitored for changes in putamen connectivity and depression severity after the training

4 weeks

Treatment Details

Interventions

• Psycho-Education
• TARA

Trial Overview The study tests if meditation training (TARA) affects brain connectivity and reduces depression in adolescents. It compares changes in the putamen region of the brain and self-rated depression symptoms between those receiving TARA and an active control group using psycho-education.

Participant Groups

Group I: Experimental: TARA Training Experimental Treatment 1 Intervention

Behavioral: Training for Awareness, Resilience, and Action (TARA) This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)

Group II: Control: Psycho-Education Active Control 1 Intervention

Behavioral: Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) without the mindfulness meditation components

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Mindfulness training led to significant improvements in psychological symptoms and quality of life for a diverse group of 143 psychiatric outpatients, indicating its overall efficacy as a therapeutic intervention.

However, patients with bipolar disorder did not show significant improvement, which may be linked to their longer illness duration and lower baseline severity compared to other diagnostic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. Bos, EH., Merea, R., van den Brink, E., et al.[2019]

Mindfulness training significantly reduces symptoms of major depressive disorder (MDD) and is particularly effective for patients with higher levels of trait mindfulness, as shown in a study of 126 hospitalized MDD patients.

The study found that trait mindfulness is negatively associated with MDD severity and positively correlated with age and marital status, suggesting that assessing mindfulness levels can help predict treatment outcomes and identify therapeutic targets for MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that contribute to trait mindfulness level among hospitalized patients with major depressive disorder. Ji, CF., Wu, GH., Du, XD., et al.[2023]

In a study of 25 formerly depressed patients, mindfulness-based cognitive therapy (MBCT) significantly increased mindfulness levels, which were measured before and after treatment.

Higher levels of mindfulness after MBCT were found to predict a lower risk of relapse or recurrence of major depressive disorder over a 12-month follow-up, suggesting that mindfulness plays a crucial role in preventing depression relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness predicts relapse/recurrence in major depressive disorder after mindfulness-based cognitive therapy. Michalak, J., Heidenreich, T., Meibert, P., et al.[2018]

In a study of 104 participants with mild to severe depression undergoing an 8-week Mindfulness-Based Intervention (MBI), social factors like instructor and group dynamics were found to be stronger predictors of improvements in depression and stress than the specific mindfulness practices themselves.

While formal meditation practice did contribute to reductions in anxiety and stress, informal mindfulness practice did not show a significant impact, suggesting that the therapeutic environment and relationships may play a crucial role in the effectiveness of MBIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Contribution of Common and Specific Therapeutic Factors to Mindfulness-Based Intervention Outcomes. Canby, NK., Eichel, K., Lindahl, J., et al.[2023]

Mindfulness Based Interventions (MBIs) have gained significant traction in recent years for their effectiveness in treating various psychiatric disorders, highlighting their growing importance in mental health care.

Research supports that MBIs work through cognitive, psychological, and neural mechanisms, making them a valuable addition to traditional treatment methods for improving mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions in Psychiatry. Shapero, BG., Greenberg, J., Pedrelli, P., et al.[2023]

In a study involving 1554 participants across five UK mental health services, mindfulness-based cognitive therapy (MBCT) was found to be effective in preventing depressive relapse, with 96% of those who entered treatment in the non-depressed range maintaining their recovery.

For participants who entered with current depression, 45% achieved recovery, and there was a significant reduction in overall depression severity, indicating that MBCT is being delivered safely and effectively in real-world settings, even beyond its original target population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Real-World Healthcare Services. Tickell, A., Ball, S., Bernard, P., et al.[2021]

Chronically depressed patients exhibited a significantly reduced error-related negativity (ERN), indicating impaired self-regulation, compared to healthy controls in a study involving 59 participants.

After two weeks of mindfulness training, patients showed a notable increase in ERN magnitude, suggesting that mindfulness can effectively improve self-regulatory capacities in those with chronic depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief training in mindfulness may normalize a blunted error-related negativity in chronically depressed patients. Fissler, M., Winnebeck, E., Schroeter, TA., et al.[2018]

Mindfulness-Based Compassionate Living (MBCL) was found to be feasible and acceptable for adults with recurrent depression, with no dropouts and high attendance rates (average 7.52 out of 8 sessions) during the intervention.

Preliminary results indicated that while the second group showed a reduction in depressive symptoms and an increase in self-compassion, the first group did not experience significant changes, highlighting the need for further research in a larger, randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Co-creation and Feasibility of a Compassion Training as a Follow-up to Mindfulness-Based Cognitive Therapy in Patients with Recurrent Depression. Schuling, R., Huijbers, M., Jansen, H., et al.[2020]

The TARA program, a group treatment for depression in adolescents and young adults, was found to be feasible and safe, with no significant adverse events reported during the 12-week intervention involving 35 participants.

While TARA did not show a significant change in self-rated depression severity, it resulted in a meaningful decrease in scores on the Children's Depression Rating Scale, indicating preliminary effectiveness in reducing depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of training for awareness, resilience, and action for adolescents and young adults with depression: The pilot phase of a multicenter randomized controlled trial. Ekbäck, E., Rådmark, L., Granåsen, G., et al.[2023]

In a study of 274 participants with a history of recurrent major depressive disorder, mindfulness-based cognitive therapy (MBCT) did not significantly reduce the overall risk of relapse compared to cognitive psychological education (CPE) or treatment as usual (TAU) over a 12-month follow-up period.

However, MBCT was particularly beneficial for individuals with a history of childhood trauma, showing a significant reduction in relapse risk compared to TAU and CPE for those with higher trauma severity, indicating that MBCT may be more effective for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. Williams, JM., Crane, C., Barnhofer, T., et al.[2022]

The Meditation-Based Lifestyle Modification (MBLM) program significantly reduced depressive symptoms in 81 patients with mild to moderate depression, showing a 13.15 point decrease in Beck Depression Inventory-II scores after 8 weeks compared to only 1.71 points in the control group and 3.34 points in the treatment as usual group.

MBLM not only improved primary depressive symptoms but also showed significant benefits in secondary outcomes related to mental health, indicating its potential as an effective, low-risk intervention for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation-based lifestyle modification in mild to moderate depression-A randomized controlled trial. Bringmann, HC., Michalsen, A., Jeitler, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Factors that contribute to trait mindfulness level among hospitalized patients with major depressive disorder. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Mindfulness predicts relapse/recurrence in major depressive disorder after mindfulness-based cognitive therapy. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Contribution of Common and Specific Therapeutic Factors to Mindfulness-Based Intervention Outcomes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions in Psychiatry. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Real-World Healthcare Services. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Brief training in mindfulness may normalize a blunted error-related negativity in chronically depressed patients. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The Co-creation and Feasibility of a Compassion Training as a Follow-up to Mindfulness-Based Cognitive Therapy in Patients with Recurrent Depression. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of training for awareness, resilience, and action for adolescents and young adults with depression: The pilot phase of a multicenter randomized controlled trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Meditation-based lifestyle modification in mild to moderate depression-A randomized controlled trial. [2022]