A Study of Adolescents Undergoing a Mindfulness Training During COVID-19

NCT04548544 | Completed Results DMC

• 1 other identifier: 19-29083 (b)
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline/randomization and 12 weeks after baseline/randomization

Study Arms (2)

TARA training

EXPERIMENTAL

Behavioral: Training for Awareness, Resilience, and Action (TARA)

Control

NO INTERVENTION

Interventions

Training for Awareness, Resilience, and Action (TARA) BEHAVIORAL

This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)

TARA training

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy female and male adolescents, 14-18 years old
• Fluency in English

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

Results Point of Contact

• Title: Olga Tymofiyeva
• Organization: University of California, San Francisco

Olga.Tymofiyeva@ucsf.edu

415-514-4870

Study Officials

• Olga Tymofiyeva, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 14, 2020
• Study Start: October 18, 2019
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)