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Healthy Mind, Healthy Living (HMHL)

Primary Purpose

Mindfulness Based Cognitive Therapy, Depression, Sleep

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Mind, Healthy Living
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mindfulness Based Cognitive Therapy focused on measuring Mindfulness Based Cognitive Therapy (MBCT), Korean Americans, Group-based, Depression, Sleep

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group-based MBCT

Arm Description

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.

Outcomes

Primary Outcome Measures

Depression
Inventory of Depressive Symptomatology QUIDS-SR

Secondary Outcome Measures

Sleep
Sleep Quality PROMIS measure

Full Information

First Posted
July 19, 2023
Last Updated
July 19, 2023
Sponsor
University of Washington
Collaborators
Asian American Resource and Information Network, Inc (AARIN)
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1. Study Identification

Unique Protocol Identification Number
NCT05965349
Brief Title
Healthy Mind, Healthy Living
Acronym
HMHL
Official Title
Evaluation of a Mindfulness-based Intervention on Depression Among Older Korean American Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Asian American Resource and Information Network, Inc (AARIN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness Based Cognitive Therapy, Depression, Sleep, Anxiety Depression
Keywords
Mindfulness Based Cognitive Therapy (MBCT), Korean Americans, Group-based, Depression, Sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group-based MBCT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Mind, Healthy Living
Intervention Description
A telephone, 8-week MBCT workshop series ncluding: (1) learning mindfulness skills; (2) practicing mindfulness skills in class and at home; and (3) dialogue and inquiry.
Primary Outcome Measure Information:
Title
Depression
Description
Inventory of Depressive Symptomatology QUIDS-SR
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Sleep
Description
Sleep Quality PROMIS measure
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Bishop, BS
Phone
206-685-2947
Email
skbishop@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Noah Segal, MS
Email
nsegal@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Ko, MPH,PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia K Bishop, BS
Phone
206-685-2947
Email
skbishop@uw.edu
First Name & Middle Initial & Last Name & Degree
Noah Segal, MS
Email
nsegal@uw.edu
First Name & Middle Initial & Last Name & Degree
Linda Ko, PhD

12. IPD Sharing Statement

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