Healthy
Conditions
Brief summary
The COVID-19 pandemic has been significantly affecting people's lives around the globe. Social distancing, self-quarantine, shelter-in-place measures, economic challenges, and COVID-19-cased illness and deaths have the potential to significantly impact mental health and cause stress, anxiety, and depression. Adolescents may be especially vulnerable to this situation, due to their increased vulnerability to the onset of depression and anxiety in general. One promising approach to reduce anxiety and depression in youth is a neuroscience-based mindfulness intervention Training for Awareness Resilience and Action (TARA). TARA is usually delivered over 12 weeks by two facilitators in groups of 10-15 adolescents in-person, and it has been shown to reduce symptoms of depression and anxiety in depressed adolescents and modify brain properties. The TARA intervention can also be delivered remotely. Other types of therapy delivered remotely, such as internet-based cognitive behavioral therapy, have shown comparable efficiency to face-to-face delivery. The objective of this study is to utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the feasibility of TARA (delivered partially over Zoom) in improving the self-reported emotional well-being primary outcome (emotional problems measured with the Strengths and Difficulties Questionnaire \[SDQ\]) in healthy adolescents between the ages of 14 to 18 years old during the COVID-19 pandemic. Our central hypothesis is that emotional well-being of adolescents in the intervention group will improve stronger (or deteriorate less) than in the control group. We will test this hypothesis in 21 adolescents randomized to the TARA intervention (partially delivered over Zoom) (12 adolescents) or to the waitlist control group (9 adolescents).
Interventions
This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
Sponsors
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 SDQ 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 100. 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) | 12 |
| Control passive control | 9 |
| Total | 21 |
Baseline characteristics
| Characteristic | Control | Total | TARA Training |
|---|---|---|---|
| Age, Continuous | 15.7 years STANDARD_DEVIATION 1.4 | 15.9 years STANDARD_DEVIATION 1.2 | 16.0 years STANDARD_DEVIATION 1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 17 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 9 participants | 21 participants | 12 participants |
| SDQ emotional symptoms | 57.3 units on a scale STANDARD_DEVIATION 10.9 | 57.1 units on a scale STANDARD_DEVIATION 10.5 | 56.9 units on a scale STANDARD_DEVIATION 10 |
| Sex/Gender, Customized female | 5 Participants | 11 Participants | 6 Participants |
| Sex/Gender, Customized male | 3 Participants | 9 Participants | 6 Participants |
| Sex/Gender, Customized other | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 9 |
| other Total, other adverse events | 0 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
Primary
Change in SDQ 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 100. Higher scores represent higher levels of emotional problems.
Time frame: Baseline/randomization and 12 weeks after baseline/randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TARA Training | Change in SDQ Emotional Problems | 2.08 units on a scale | Standard Deviation 5.53 |
| Control | Change in SDQ Emotional Problems | -4.49 units on a scale | Standard Deviation 4.71 |
Comparison: timepoint × group interactionp-value: 0.38ANOVA