A Randomized Controlled Feasibility Study of Emotional Well-being of Adolescents Undergoing a Mindfulness Training During the COVID-19 Pandemic
Phase: NA
Conditions: Healthy
Sponsor: University of California, San Francisco

 
 
 
 
 
 
ClinicalTrials.gov Document 
Project Title: A Randomized Controlled Feasibility Study of Emotional Well-being 
of Adolescents Undergoing a Mindfulness Training During COVID-19 
Identifier: NCT04548544 
Last approved: July 23, 2020 Uploaded: Nov 27, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A randomized controlled feasibility study of emotional well-being of adolescents 
undergoing a mindfulness training during the COVID-19 pandemic 
 
 
Specific Aims 
 
 
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) (Henje Blom et al., 2014). 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 (Henje Blom et al., 2016) and modify 
brain properties (Yuan et al., 2020). 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 (Carlbring et al., 2017). 
 
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). 
We will pursue the follow Specific Aim: 
 
Specific Aim 1. To study changes in emotional well-being in healthy teens with mindfulness training 
during the COVID-19 pandemic. Hypothesis 1: Internalizing emotional problems as measured by the SDQ will 
decrease in the training group compared to controls. 
 
With respect to expected outcomes, the work proposed here is expected to establish feasibility of remotely 
delivered TARA intervention in reducing emotional problems of adolescents during the COVID-19 pandemic. 
The important general positive impact of this study lies in the possibility of offering a neuroscience-based 
mindfulness intervention remotely to youth living in remote areas and for all youth during pandemic times, in 
order to help reduce their depression and anxiety, and prevent development of the Major Depressive Disorder, 
a highly prevalent illness ranked as the #1 leading cause of disability worldwide (WHO, 2017) that dramatically 
increases and often begins during adolescence. 
 
 
 

Research Plan 
 
Objectives  
 
The primary objective will be to test the feasibility of a neuroscience-based mindfulness intervention in 
improving the self-reported emotional well-being in healthy adolescents between the ages of 14 to 18 years old 
during the COVID-19 pandemic. Hypothesis: Internalizing emotional problems will decrease in the training 
group compared to controls. 
 
Design and Outcomes   
 
The current research study design will utilize an individually randomized group treatment, open-label, waitlist-
controlled clinical trial design. 
 
Primary Outcome: emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ). The 
SDQ self-assessment will be done remotely via a Qualtrics questionnaire. 
 
Interventions and Duration  
 
The study will compare a 12-session neuroscience-based mindfulness group intervention Training for Awareness 
Resilience and Action (TARA) (Henje Blom et al., 2014) with a waitlist control group. The intervention duration 
is 1.5 hours per week for 12 weeks. The first 5 TARA sessions will be conducted in-person. The last 7 session 
will be delivered over Zoom. 
 
Sample Size and Population 
 
The target population for the current study will be 21 healthy female and male adolescents that are between the 
ages of 14 to 18 years old who are randomly assigned to the TARA intervention or waitlist control group.  
 
Inclusion Criteria: Healthy female and male adolescents, 14-18 years old. Fluency in English. Exclusion Criteria: 
MRI contraindications and pregnancy; 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.  
 
Recruitment of potentially eligible participants will be primarily performed in the San Francisco Unified School 
District (SFUSD) using IRB-approved flyers. 
 
Data Analyses  
 
Our hypothesis is that TARA training will improve emotional problems as assessed by the SDQ T-score 
compared with controls. We will use an analysis of covariance (ANCOVA) accounting for sex and fit by maximum 
likelihood. Stata (College Station, TX) will be used to perform data analyses. 
 
References: 
 
Blom Henje E, Duncan LG, Ho TC, Connolly CG, LeWinn KZ, Chesney M, Hecht FM, Yang TT. The development of an RDoC based 
treatment program for adolescent depression “Training for Awareness, Resilience, and Action” (TARA). Front Hum Neurosci 8:630. 2014. 
PMID: 25191250. PMCID: PMC4137278. 
 
Blom Henje E, Tymofiyeva O, Chesney M, Ho TC, Moran P, Connolly CG, Duncan LG, Baldini L, Weng HY, Acree M, Goldman V, Hecht 
FM, Yang TT. Feasibility and preliminary efficacy of a novel RDoC-based treatment program for adolescent depression: Training for 
Awareness Resilience and Action (TARA)—A Pilot Study. Front Psychiatry 7:208. 2016. PMID: 28138319. PMCID: PMC5237634. 
 
Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlöf E. Internet-based vs. face-to-face cognitive behavior therapy for 
psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cognitive Behaviour Therapy. 2018;47(1):1-18. 
 
Yuan JP, Connolly CG, Blom EH, Sugrue LP, Yang TT, Xu D, Tymofiyeva O. Grey matter changes in adolescents participating in a 
meditation 
training. 
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Available 
from: 
https://www.frontiersin.org/articles/10.3389/fnhum.2020.00319/abstract