NCT05965349

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
6 days until next milestone

Results Posted

Study results publicly available

January 6, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

July 19, 2023

Results QC Date

August 21, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

Mindfulness Based Cognitive Therapy (MBCT)Korean AmericansGroup-basedDepressionSleep

Outcome Measures

Primary Outcomes (1)

  • Depression

    Quick Inventory of Depressive Symptomatology (QIDS-SR); score ranges from 0-27 with higher scores indicating more depressive symptoms.

    8 weeks

Secondary Outcomes (1)

  • Sleep

    8 weeks

Study Arms (1)

Group-based MBCT

EXPERIMENTAL

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.

Behavioral: Healthy Mind, Healthy Living

Interventions

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.

Group-based MBCT

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Linda Ko
Organization
University of Washington

Study Officials

  • Linda Ko, MPH,PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor: School of Public Health

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 28, 2023

Study Start

April 3, 2023

Primary Completion

June 5, 2024

Study Completion

December 31, 2024

Last Updated

April 3, 2025

Results First Posted

January 6, 2025

Record last verified: 2025-03

Locations