- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05965349
MBCT Intervention: Healthy Mind, Healthy Living (HMHL)
Evaluation of a Mindfulness-based Intervention on Depression Among Older Korean American Adults
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sonia Bishop, BS
- Phone Number: 206-685-2947
- Email: skbishop@uw.edu
Study Contact Backup
- Name: Noah Segal, MS
- Email: nsegal@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- Recruiting
- University of Washington
-
Contact:
- Noah Segal, MS
- Email: nsegal@uw.edu
-
Contact:
- Sonia K Bishop, BS
- Phone Number: 206-685-2947
- Email: skbishop@uw.edu
-
Principal Investigator:
- Linda Ko, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group-based MBCT
A telephone-based, 8-week MBCT session including: (1) learning mindfulness skills; (2) practicing mindfulness skills in class and at home; and (3) dialogue and inquiry.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: 8 weeks
|
Inventory of Depressive Symptomatology QUIDS-SR
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep
Time Frame: 8 weeks
|
Sleep Quality PROMIS measure
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Linda Ko, MPH,PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00015538
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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