Trial Outcomes & Findings for Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study (NCT NCT04254796)

Last Updated: 2023-06-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

Baseline/randomization and 12 weeks after baseline/randomization

Results posted on

2023-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	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)	Control Waitlist Control
Overall Study STARTED	50	50
Overall Study COMPLETED	45	49
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TARA Training n=50 Participants Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)	Control n=50 Participants Waitlist Control	Total n=100 Participants Total of all reporting groups
Age, Continuous	15.81 years STANDARD_DEVIATION 1.37 • n=5 Participants	16.04 years STANDARD_DEVIATION 1.29 • n=7 Participants	15.93 years STANDARD_DEVIATION 1.33 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	44 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	19 Participants n=5 Participants	9 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline/randomization and 12 weeks after baseline/randomization

Outcome measures

Outcome measures
Measure	TARA Training n=45 Participants Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)	Control n=49 Participants Waitlist Control
Change in Putamen Node Strength	0.73 unitless Standard Deviation 4.07	-0.42 unitless Standard Deviation 4.30

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TARA Training n=45 Participants Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)	Control n=48 Participants Waitlist Control
Change in Emotional Problems	2.12 score on a scale Standard Deviation 9.82	0.20 score on a scale Standard Deviation 7.15

Adverse Events

TARA Training

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TARA Training n=50 participants at risk Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)	Control n=50 participants at risk Waitlist Control
Psychiatric disorders Suicidal ideation leading to hospitalization.	2.0% 1/50 • Number of events 1 • 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.	0.00% 0/50 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Olga Tymofiyeva

University of California, San Francisco

Phone: 415-514-4870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place