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| ID | Type | Description | Link |
|---|---|---|---|
| 5R25MH060482 | U.S. NIH Grant/Contract | View source | |
| 1R61AT009864-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TARA Training | Experimental | 12-week group TARA Training |
|
| Control | No Intervention | Waitlist Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training for Awareness, Resilience, and Action (TARA) | Behavioral | This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline/randomization and 12 weeks after baseline/randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline/randomization and 12 weeks after baseline/randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Tymofiyeva, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39193038 | Derived | Tymofiyeva O, Sipes BS, Luks T, Hamlat EJ, Samson TE, Hoffmann TJ, Glidden DV, Jakary A, Li Y, Ngan T, Henje E, Yang TT. Interoceptive brain network mechanisms of mindfulness-based training in healthy adolescents. Front Psychol. 2024 Aug 13;15:1410319. doi: 10.3389/fpsyg.2024.1410319. eCollection 2024. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Control | Waitlist Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | unitless | Baseline/randomization and 12 weeks after baseline/randomization |
|
12 weeks
Solicited adverse events in TARA participants were captured as follows: (1) before each TARA session participants were asked through a questionnaire: "Has there been any significant unfavorable change in your mental or physical health since last class?"; (2) if the participant answered "yes" to this question, then a study staff member asked the participant for additional details regarding the participant's answer and this information was recorded in the Adverse Event form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation leading to hospitalization. | Psychiatric disorders | Systematic Assessment | Parent states that the cause was family-related problems and was in no way related to the TARA intervention (study records contain Note to File) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olga Tymofiyeva | University of California, San Francisco | 415-514-4870 | olga.tymofiyeva@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2020 | Feb 2, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2022 | Feb 3, 2023 | ICF_001.pdf |
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Waitlist Control
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Control |
Waitlist Control |
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|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline/randomization and 12 weeks after baseline/randomization |
|
|
|
| 0 |
| 50 |
| 1 |
| 50 |
| 0 |
| 50 |
| EG001 | Control | Waitlist Control | 0 | 50 | 0 | 50 | 0 | 50 |
|
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