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

NCT ID: NCT04548544

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2020-05-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

TARA training

Group Type: EXPERIMENTAL

Training for Awareness, Resilience, and Action (TARA)

Intervention Type: BEHAVIORAL

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training for Awareness, Resilience, and Action (TARA)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Tymofiyeva, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19-29083 (b)

Identifier Type: -

Identifier Source: org_study_id