Evaluation of a Mindfulness-based Intervention on Depression Among Older Korean American Adults
Phase: NA
Conditions: Mindfulness Based Cognitive Therapy, Depression, Sleep, Anxiety Depression
Sponsor: University of Washington

Working Protocol Version: 3 
Date: 2/15/23 
IRB Approved: 3/03/2023 
Healthy Mind, Healthy Living 
Evaluation of a Mindfulness-based Intervention on Depression among Older Korean American Adults 
Asian American Resource and Information Network, Inc (AARIN)  
and University of Washington (UW) 
 
Clinical Trials Registration: NCT05965349 (MBCT Healthy Mind Healthy Living (HMHL) 
 
 
 
 
 

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Table of Contents 
Rationale and Background Information 
Eligibility Criteria 
Participant Recruitment 
HMHL Intervention 
Data Collection 
Data Analysis 
Workflow for Recruitment 
Appendix A – Study Recruitment Flyer  
Appendix B – Phone Call Scripts  
Appendix C – Eligibility Screener  
Appendix D – Study Consent and Baseline Survey 
Appendix E – HMHL SOP Screening & Consent Information  
Appendix F – Follow-up Survey  
Appendix G – Semi-structured Interview Guide 
Appendix H – HMHL Data Safety Monitoring Plan 
 
 
 

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Rational and Background Information 
Older Asian American adults (> 65) are a rapidly growing racial/ethnic group in the United States, in which their 
total population is expected to nearly double from 2016 to 2030. In the context of the COVID-19 pandemic, older 
adults are a particularly vulnerable group as this group has an increased risk of poor prognosis due to high rates of 
chronic disease such as diabetes, cardiovascular disease, and cancer. In the absence of a vaccine for COVID-19, 
public health strategies consisted of isolation, quarantine, social distancing, and community containment. While the 
preventive strategies lower the risks for exposure, these strategies pose challenges for older adults who already 
experience isolation due to diminishing social network. For older AA & NHPI adults, these experiences are further 
magnified due to language barriers to accessing information and limited ability to network with culturally relevant 
groups. Furthermore, a survey on life satisfaction indicated that Asian American older adults reported lower 
satisfaction and higher unmet social and emotional needs than other race and ethnicities.1Finally, increased racism 
since the pandemic poses another layer of complexity for Asian American older adults.  
Public health efforts have repeatedly marginalized older Asians’ mental health needs through systematic exclusion 
of non-English/Spanish speakers in national surveys. Limited English proficiency (LEP) is a term used to describe 
individuals who do not speak English as their primary language and who have limited ability to read, speak, write, 
or understand English.2 According to the 2010 Census, more than 18% of the U.S. population (47 million Americans) 
do not speak English as their primary language, and more than 25 million speak English less than “very well.”2 
Asian immigrants are the second largest group with LEP status after Hispanics.3 Approximately 89% of older Asian 
Americans are foreign-born, and 62% are LEP, with 84% of Vietnamese and Koreans reporting LEP.4 The LEP 
population experiences higher burdens in health and access to care compared to their English-speaking 
counterparts, but surveys do not always capture these disparities.5-8 For example, the prevalence of depression 
using data from the National Health and Nutrition Examination survey (NHANES) shows lower reports of depression 
(3.1%) among older Asians compared to non-Hispanic Whites (7.9%), Hispanics (8.2%), and non-Hispanic Blacks 
(9.2%).9 NHANES is in English and Spanish only. When a large study (n=175,956) attempted to include survey 
reminders in Chinese, depressive symptoms among older Asians (11%–21%) were greater than non-Hispanic 
Whites (9%), non-Hispanic Blacks (16%), and similar to Hispanics (17%–23%).10 Depression rates drastically 
escalated to 44% when surveys (n=2,609) were administered in five Asian languages (Asian Indian, Chinese, 
Filipino, Korean, and Vietnamese), with 55% of Vietnamese reporting depression.11 In addition, LEP status also 
consistently emerges as the most prominent factor for lower mental health service use and increased unmet mental 
health needs among older Asians.11 This methodologic limitation suggests that the burden of depression among 
non-English/Spanish speaking older Asian adults is not represented in the national health profiles of the U.S. 
population, and our current knowledge may be a small glimpse of a much larger health issue.   
 
Mindfulness-based cognitive therapy (MBCT) is a group-based intervention rooted in Eastern ideology but taught 
from a secular perspective.12 MBCT combines mindfulness training and cognitive therapy to improve emotion 
regulation and reduce negative emotions.12 A core feature of MBCT is the cultivation of mindfulness, defined as a 
nonjudgmental awareness of present-moment experiences and an accepting attitude towards oneself and the 
surroundings.13 Several meta-analyses have demonstrated MBCT reduces depression relapse.14-16 and active 
depression.17-19, 20   MBCT has also been embraced in Asian countries. A systematic review of MBCT intervention 
among Asians showed 40 studies covering diverse groups.21 However, the effects of the MBCT among older Asian 
Americans remain understudied.  
 
We will collaborate with a community-based organization named Asian American Resource and Information 
Network (AARIN) to implement an MBCT intervention with older Korean adults. This is a collaborative project 
between AARIN and the University of Washington (UW) will recruit 40 Korean Americans ages 505 and older to 
participate in an 8-session MBCT program delivered by staff members of AARIN.   
Specific Aims 
1) To implement the mindfulness-based cognitive therapy (MBCT) intervention.  

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2)  To assess the acceptability and relevance of MBCT, as well as its impact on patient reported outcomes among 
older Korean adults, ages 505-89. 
Overall Research Design  
We will conduct a single arm, pre/post pilot intervention study to examine the effect of MBCT on depression 
among older Korean American adults.  We will recruit older Korean adults (n=40) from AARIN to complete the 8-
session Healthy Mind, Healthy Living intervention, along with periodic mental health assessments.  
 
Eligibility Criteria 
Inclusion criteria: To be eligible, the participants must: (1) self-identify as a Korean person, (2) be between the ages 
505 and 89, (3) has mild to moderate depressive symptoms (scores between 5-14 when assessed using Patient 
Health Questionnaire-9 (PHQ-9), (4) has limited English proficiency (responds “less than very well” when asked 
“how well do you speak English”?) and fluency in Korean (e.g. able to speak at a native level), and (5) willing to 
give a written consent to participate in the study.  
Exclusion criteria include: Individuals will not be able to participate if they have any of the following criteria: (1) major 
psychiatric diseases that would interfere with participants’ ability to participate in or receive the benefit from the 
mental health interventions (e.g., bipolar disorder, schizophrenia, recent history of psychosis or mania, severe 
depressive symptoms); (2) used drugs other than those required for medical reasons; (3) serious medical conditions 
(e.g., poorly controlled diabetes, severe congestive heart failure) that has not been stable for at least 3 months; (4) 
current active suicidal or self-injurious behavior, potentially necessitating immediate treatment; (5) general 
conditions that would impede participation in a group intervention (e.g., cognitive impairment, tendencies toward 
physical aggression); (6) prior history of engaging in formal mindfulness-based interventions including mindfulness-
based stress reduction, MBCT, Acceptance and Commitment Therapy, and Dialectical Behavioral Therapy; and (7) 
significant current meditation practice, specifically more than three hours of insight/mindfulness/vipassana 
meditation per week. 
Participant Recruitment 
AARIN will recruit older Korean Adults through partnering organizations, social media, such as Kakao Talk which 
is a popular messaging application among Korean Americans.  
The AARIN staff will collaborate with partnering organizations to send a study flyer (APPENDIX A – HMHL Study 
Flyer) to potential participants. AARIN staff will recruit participants directly from partnering organizations by 
visiting the organization or attending their scheduled activities. AARIN staff will also ask the partnering 
organizations to refer their potential clients who show interest in participating in the study. Potential participants 
will share their contact information with partnering organizations for AARIN to contact them with more information 
about the study.   
Dr. Lee will call potential participants, speaking in the language of their preference (English or Korean), to describe 
the study and gauge their interest in participating in the study and their eligibility (APPENDIX B – Phone Scripts). 
Depending on the participant’s capability, enrollment will take place in person, or via zoom/phone. After the eligibility 
of the participant is confirmed, Dr. Lee will present the Consent Information. Though this study will have a waiver 
of written documentation of consent, Dr. Lee will still read through the Consent Information which includes key 
information about the study. Dr. Lee will verify that that the participant has heard the Consent Information, was able 
to ask questions, and has agreed to participate in the study. Dr. Lee will administer the screener, present the 
Consent Information, and administer the Baseline Survey for those eligible and willing to participate. The consent 
process will be documented in REDCap.  (APPENDIX D – Study Consent & Baseline Variables; APPENDIX E – 
HMHL Screening & Consent SOP).  
Consent 
Since this study is considered “minimal risk” it is exempt from requiring the  written documentation of consent. 
However, the study staff will still present participants with the key information required for informed consent. 

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In-person Consent Information 
Dr. Lee will read through a hard copy of the Consent Information with the participant and answer any questions 
that arise. If the participant has no questions and agrees to participate, Dr. Lee will mark an “X” on the Consent 
Information document to verify the participant has agreed to participate. Dr. Lee will track this process and update 
the participants Consent Information document in REDCap when she uploads the other survey responses. The 
participant will keep a copy of the Consent Information for themselves.  
Online or Phone Consent Information 
Prior to the enrollment session, participants enrolling via phone/zoom and who use email will receive an email 
with the Consent Information in their preferred language, those who do not use email will receive it via mail. If the 
screener is administered via phone/zoom, participants will provide verbal consent to confirm their participation in 
the study. The consent document will be read to the participants by Dr. Lee once their eligibility has been 
confirmed through the administration of the screener. If the enrollment is taking place over zoom, the participant 
will visually see a copy of the Consent Information on the screen through REDCap as the study staff member 
reads the Consent Information and answers questions. If it is administered via phone, Dr. Lee will read the 
Consent Information to the participant in the participants preferred language. If the participant has no questions, 
Dr. Lee will verbally confirm that the study participant agrees to participate and check’s the “agree to participate” 
in REDCap and mark the document with an “X” to verify the participant has given verbal permission to participate. 
If a participant indicates they would like to receive the Consent Information via email, REDCap will automatically 
send the participant a copy of the Consent Information to their designated email address. If they would prefer to 
receive a paper copy of the Consent Information, the document will be mailed to them at their given address. 
The workflow for the recruitment, consent, and data collection for the AARIN staff member and the University of 
Washington team member are outlined.  
Workflow for Development, Recruitment, and Data Collection 
# 
Responsibility 
Activity 
1 
University of Washington 
Develop the research protocol and consent. 
2 
University of Washington 
Submit the IRB application 
3 
University of Washington/Dr. 
Visvanathan 
Create the MBCT training protocol, the survey instrument and 
semi-structured interview guide.  
4 
Dr. Visvanathan 
Provide training on MBCT and provide implementation support. 
5 
AARIN 
Recruit 40 participants for the MBCT program. 
6 
AARIN 
Receive training on MBCT. 
7 
AARIN 
Implement the MBCT program with 40 participants, 5 groups. 
8 
AARIN 
Conduct baseline and post assessment survey – in-person or 
telephone survey. 
9 
AARIN 
Enter survey data to REDCap. 
10 AARIN 
Send incentives to participants. 
11 AARIN 
Conduct and record semi-structured interviews with 12 
participants. 
12 University of Washington 
Transcribe the interviews 
13 University of Washington & AARIN 
Analyze the data. 
14 University of Washington & AARIN 
Collaborate on conference presentations and manuscript 
preparation.  
 
 
HMHL Intervention 
A telephone-based MBCT will be delivered by AARIN staff members. Prior to the delivery of the MBCT the staff 
members at AARIN will be trained by Dr. Visvanathan, a certified MBCT instructor and developer of the remote-
delivered MBCT protocol. The training will include 1) experiential training from participating in the 8-week MBCT 
intervention, 2) didactic training on how to deliver the intervention (how to lead meditations and cognitive exercises 

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and conduct participants inquiry), and 3) supervision as the staff member at AARIN lead their first 8-week MBCT 
group. 
 
Table 1 shows critical components of MBCT including: (1) learning mindfulness skills; (2) practicing mindfulness 
skills in class and at home; and (3) dialogue and inquiry. All sessions will be audio-recorded to allow the staff at 
AARIN to access them later as a resource. 
 
 
 
 
Dr. Visvanathan will also provide weekly supervision. We will ensure fidelity by using treatment manuals, session 
fidelity checklists, and weekly supervision of session audio recordings to minimize drift. Treatment fidelity will be 
evaluated by two independent raters, with a minimum of 85% inter-rater reliability, using the Remote-Delivered 
MBCT-Treatment Adherence Competence Scale (MBCT-TACS).130 We will recruit 40 older Korean Americans. 
AARIN will deliver  five, eight-week MBCT sessions with 8 participants per group (n=40).    
 
Data Collection 
Individual participants’ mental health status will be assessed at pre and post MBCT delivery using PHQ-9 and quick 
inventory of Depressive Symptomatology (QIDS) across all conditions (APPENDIX F – Follow-up survey. At the 
end of the study, we will conduct semi-structured interviews with 12-16 older adults to understand acceptability and 
cultural relevance of the MBCT for older Korean adults (APPENDIX G – Semi-structured Interview Guide).   
Survey data of participants include depressive symptoms, immigrant stress, sleep quality, socio-demographic 
characteristics, major chronic diseases, healthcare, beliefs on mental health, and medications. All measures will be 
collected using validated standardized measures.   
Timeline with detailed activities 
 
Table 1: Structure and Content of MBCT 

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Data Analysis  
Survey data Analysis: All analyses will be done in SAS Version 9.4. We will generate frequencies for categorical 
variables and means for continuous variables. To assess the effect of MBCT, we will compare depression outcomes 
pre/post using T-test. A two-sided test with a level of 0.05 will be used.  
 
Semi-structured Interview Data Analysis: Transcripts will be uploaded into ATLAS.ti Version 8. Two analysts will 
use an inductive, constant comparison approach, in which concepts will be identified and themes derived from 
interview data. Using an iterative process, two analysts will meet weekly to refine the codebook, adding, removing, 
and revising codes, as needed, to address inter-rater agreement and to compare new data with existing data. We 
will build consensus around themes that are identified throughout the coding and analysis process. We will compare 
the themes arising from the data and determine possible linkages across participants and thematic categories.   
 
Data Safety Monitoring Plan 
A detailed data safety monitoring plan is outlined in APPENDIX H. 
 
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