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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how meditation might reduce depression symptoms in teens. Researchers aim to determine if meditation strengthens specific brain connections related to the putamen, a region involved in movement and learning, and if this change correlates with reduced depression. Two groups will participate: one in a specialized meditation program called TARA (Training for Awareness Resilience and Action), and the other in general psycho-education. Teens aged 14-18 with depression or anxiety who aren't heavily involved in other mindfulness practices may be suitable candidates. As an unphased study, this trial offers a unique opportunity for teens to explore innovative approaches to managing depression.

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 prior data suggests that this meditation training is safe for adolescents?

Research has shown that the Training for Awareness, Resilience, and Action (TARA) program has been tested on teenagers with depression. In earlier studies, TARA proved practical and showed early success in reducing depression symptoms in young people aged 15 to 21. Importantly, these studies did not report any major safety concerns or harmful side effects from the TARA program, suggesting it is well-tolerated by teenagers. Participants generally completed the 12-week program without major issues, supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Meditation for Depression trial because it explores non-traditional approaches to managing depression, specifically through the TARA (Training for Awareness, Resilience, and Action) method. Unlike standard treatments like antidepressants or cognitive-behavioral therapy, TARA incorporates mindfulness and meditation, aiming to enhance awareness and resilience. This approach could offer a new mechanism for tackling depression by focusing on mental and emotional skills rather than solely on chemical or cognitive pathways. Additionally, the trial also investigates a variant of TARA without mindfulness meditation components, which could reveal which elements are most effective. Overall, these insights could pave the way for more personalized and holistic depression treatment options.

What evidence suggests that this meditation training is effective for depression?

Research has shown that TARA (Training for Awareness, Resilience, and Action), which participants in this trial may receive, can help reduce symptoms of depression. In one study, 35 young people aged 15 to 21 who experienced depression felt better after 12 weeks of TARA training. They became more aware of their stressors and learned new coping strategies. Another study found early evidence that TARA reduced depression and anxiety in teenagers. This suggests that TARA might improve depression by teaching mindfulness and resilience skills. Meanwhile, the control group in this trial will receive Psycho-Education, focusing on training for awareness, resilience, and action without mindfulness meditation components. ^{1 2 3 4 6}

Who Is on the Research Team?

Tony T Yang, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8542661/

Clinical Effectiveness of Training for Awareness Resilience ... This will be the first RCT to examine the effects of TARA compared to standard treatment for adolescents and young adults with MDD or PDD.

2. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1130035/full

Clinical effectiveness of training for awareness, resilience ... Thirty-five depressed individuals (15–21 years old, 28 females) received TARA for 12 weeks face-to-face or online. Data was collected before (T0) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8883651/

a single-arm mixed methods feasibility study to evaluate TARA ... As a result of TARA, they reported an increased awareness of what stressors they had, as well as new skills to effectively manage them. ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04747340?cond=clinical%20depression%20in%20adults&viewType=Table&rank=2

NCT04747340 | Clinical Effectiveness of TARA Compared ... The novel group treatment program "Training for Awareness, Resilience, and Action" (TARA) was developed to target specific mechanisms based on neuroscientific ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2016.00208/full

Feasibility and Preliminary Efficacy of a Novel RDoC ... Conclusion: TARA is feasible in a sample of clinically depressed and/or anxious adolescents and preliminary efficacy was demonstrated by reduced depression and ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/96/NCT04254796/Prot_SAP_000.pdf

Neural mechanisms of meditation training in healthy and ... In the proposed study, we will use a type of secular mindfulness meditation practiced in the. Training for Awareness, Resilience, and Action ( ...