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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05965349
Other study ID # STUDY00015538
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 3, 2023
Est. completion date March 31, 2024

Study information

Verified date November 2023
Source University of Washington
Contact Sonia Bishop, BS
Phone 206-685-2947
Email skbishop@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Depression among older Korean Americans are rising. Mindfulness-based cognitive therapy (MBCT) is an evidence-based intervention (EBI), effective for preventing depression relapse and reducing depressive symptoms. To enhance feasibility, acceptability, and reach, a brief version of MBCT has been developed and delivered by telephone (brief MBCT-T), but has only been tested in primarily White samples. This study will test test the effect of brief MBCT-T among older Korean Americans.


Description:

Older Asians with limited English proficiency have experienced the greatest increase in depression before and during the COVID-19 pandemic compared to Whites, Blacks, and Hispanics. Social distancing measures to lower the risk of exposure to COVID-19, a diminishing social network, limited opportunities with social groups, and lack of access to culturally and linguistically relevant health information have all contributed to increased depression among older Asians. In addition, increases in hate speech and racist crimes against Asians have created a hostile living environment for older Asians, further contributing to depression. Mindfulness-based cognitive therapy (MBCT) is effective for preventing depression relapse and active depression. Our team has created a brief telephone-based MBCT which has been shown to be acceptable primarily white primarily white population. The acceptability of MBCT among older Korean Americans remain understudied. Community-based organizations (CBOs) are places for accessing federal and state programs, receiving culturally and linguistically appropriate health education, and supporting and socializing with other older Asians. Our preliminary study shows that 1) CBOs are ideal settings for offering MBCT-T because they have the infrastructure, capacity, cultural understanding, and trust of communities, and 2) many CBOs feel the urgency to address older Asians' escalating rates of depression and asked for assistance with training and implementation of MBCT-T. We will partner with a CBO that serves large older Korean American population to conduct a pilot study to assess the acceptability, feasibility, and preliminary impact of a CBO delivered MBCT program on depression among older Korean Americans.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 89 Years
Eligibility Inclusion Criteria: - Participants must: (1) self-identify as a Korean person, (2) be between the ages 55 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: - 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); (65) prior history of engaging in formal mindfulness-based interventions including mindfulness-based stress reduction, MBCT, Acceptance and Commitment Therapy, and Dialectical Behavioral Therapy; and (76) significant current meditation practice, specifically more than three hours of insight/mindfulness/Vipassana meditation per week.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthy Mind, Healthy Living
A telephone, 8-week MBCT workshop series including: (1) learning mindfulness skills; (2) practicing mindfulness skills in class and at home; and (3) dialogue and inquiry.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington Asian American Resource and Information Network, Inc (AARIN)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Inventory of Depressive Symptomatology QUIDS-SR 8 weeks
Secondary Sleep Sleep Quality PROMIS measure 8 weeks
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