MBCT Intervention: Healthy Mind, Healthy Living

Depression Clinical Trial

— HMHL  

Official title:

Evaluation of a Mindfulness-based Intervention on Depression Among Older Korean American Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965349
• Other study ID #: STUDY00015538
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety Depression
• Depression
• Depressive Disorder
• Mindfulness Based Cognitive Therapy
• Sleep

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