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NCT04548544 · ClinicalTrials.gov registry record · NA
A Study of Adolescents Undergoing a Mindfulness Training During COVID-19
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04548544 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 21 participants.
The verdict
NCT04548544, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study 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
- BEHAVIORAL Training for Awareness, Resilience, and Action (TARA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-10-18 |
| Est. Completion | 2020-05-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04548544
The ClinicalTrials.gov registry entry for NCT04548544 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Training for Awareness, Resilience, and Action (TARA) is the first listed.
NCT04548544 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04548544 about?
NCT04548544 is a clinical study titled "A Study of Adolescents Undergoing a Mindfulness Training During COVID-19". 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 de...
What is the current status of trial NCT04548544?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2019-10-18. Estimated completion is 2020-05-20.
What interventions are being tested in trial NCT04548544?
The interventions under investigation include: Training for Awareness, Resilience, and Action (TARA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04548544?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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