Healthy
Conditions
Brief summary
The primary objective will be to study changes in putamen structural connectivity in healthy teens with meditation training. Hypothesis: Putamen structural node strength will increase in the training group compared to controls. R61 Go/No-Go Criteria. Detect an effect size (a threshold of Cohen's d \> 0.20) in changes of the primary mechanistic outcome (Putamen structural node strength) by the described meditation training in 100 healthy adolescents that are 14-18 years old and retain at least 80% of randomized participants for primary outcome measurement at the end of the study regardless of adherence to the intervention. The secondary objective will be to study changes in emotional problems in healthy teens with meditation training. Hypothesis: There will be a significant decrease in emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ) in the training group compared to controls. Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the efficacy and safety of the investigator's innovative mindfulness meditation intervention (Training for Awareness Resilience and Action \[TARA\]) on the primary outcome (Putamen structural node strength) and secondary outcome (emotional problems measured with the Strengths and Difficulties Questionnaire \[SDQ\]) in healthy adolescents between the ages of 14 to 18 years old.
Interventions
This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Mental Health (NIMH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female and male adolescents, 14-18 years old * Fluency in English
Exclusion criteria
* Subjects younger or older than 14-18 years old. * Subjects who are not healthy. Subjects who are taking any psychotropic medication. * MRI contraindications (ferromagnetic objects on or inside the body, e.g., braces) and pregnancy. * Not allowable: Current mindfulness training (e.g. MBSR, MBCT, DBT) and/or practice with a typically sitting meditation or yoga of 20 or more minutes two or more times per week within 60 days prior to study entry. * Potential adolescent subjects with current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to the study requirements will be excluded and not allowed to enter the study. * Potential subjects with an inability or unwillingness to give written informed assent or whose legal guardian/representative are unable or unwilling to give written informed consent will be excluded and not allowed to enter the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Putamen Node Strength | Baseline/randomization and 12 weeks after baseline/randomization | Change in the Putamen node strength assessed using diffusion MRI. Node strengths are calculated as the sum of connection weights between the brain region of interest and all other nodes in the network. Higher values of node strength in general indicate stronger white matter connectivity between a specific brain region and the other regions, often caused by higher myelination. Higher values of change in node strength, similarly, indicate a higher level of structural network change occurred within the tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Emotional Problems | Baseline/randomization and 12 weeks after baseline/randomization | Change in the level of emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ). The emotional problems scores have a possible range of 0 to 10. Higher scores represent higher levels of emotional problems. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TARA Training Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) | 50 |
| Control Waitlist Control | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | TARA Training | Total | Control |
|---|---|---|---|
| Age, Continuous | 15.81 years STANDARD_DEVIATION 1.37 | 15.93 years STANDARD_DEVIATION 1.33 | 16.04 years STANDARD_DEVIATION 1.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 16 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 82 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 19 Participants | 28 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 53 Participants | 28 Participants |
| Region of Enrollment United States | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 28 Participants | 57 Participants | 29 Participants |
| Sex: Female, Male Male | 22 Participants | 43 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 1 / 50 | 0 / 50 |
Outcome results
Primary
Change in Putamen Node Strength
Change in the Putamen node strength assessed using diffusion MRI. Node strengths are calculated as the sum of connection weights between the brain region of interest and all other nodes in the network. Higher values of node strength in general indicate stronger white matter connectivity between a specific brain region and the other regions, often caused by higher myelination. Higher values of change in node strength, similarly, indicate a higher level of structural network change occurred within the tissue.
Time frame: Baseline/randomization and 12 weeks after baseline/randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TARA Training | Change in Putamen Node Strength | 0.73 unitless | Standard Deviation 4.07 |
| Control | Change in Putamen Node Strength | -0.42 unitless | Standard Deviation 4.3 |
Comparison: The goal of the analysis was to measure the effect size of the change in the primary mechanistic outcome (Putamen structural node strength), with a Go/No-Go threshold of Cohen's d \> 0.20.95% CI: [-0.13, 0.68]
Secondary
Change in Emotional Problems
Change in the level of emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ). The emotional problems scores have a possible range of 0 to 10. Higher scores represent higher levels of emotional problems.
Time frame: Baseline/randomization and 12 weeks after baseline/randomization
Population: Note: 12 weeks after randomization, emotional problems measured with SDQ weren't acquired in one additional subject in the control group (resulting in 48 subjects with the secondary outcome measure in the control group). The study records contain Note to File, which states that the subject completed their second MRI, and the subject and their parent received an email containing a link to the study questionnaire but they never completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TARA Training | Change in Emotional Problems | 2.12 score on a scale | Standard Deviation 9.82 |
| Control | Change in Emotional Problems | 0.20 score on a scale | Standard Deviation 7.15 |