Culturally Tailored Mindfulness-Positive Psychological Intervention Using Virtual Reality

Mental Health Issue Clinical Trial

Official title:

Discrimination and Mental Health of Older Korean Adults in the U.S.: Feasibility and Pilot Trial of a Culturally Tailored Mindfulness-Positive Psychological Intervention Using Virtual Reality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06019416
• Other study ID #: 23430
• Status: Completed
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: May 19, 2023

Study information

• Verified date: August 2023
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to explore the experience of older Korean adults with anti-Asian racism in the U.S. and investigate the feasibility, acceptability, and preliminary efficacy of a virtual reality-based culturally tailored mindfulness-positive psychological intervention. Primary outcome is racism-related stress and secondary outcomes are negative mental health (e.g., anxiety, depressive symptoms, and anxiety) and positive psychological well-being (e.g., positive affect, optimism, life engagement, mindful attention awareness).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 19, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• U.S. Korean Americans/immigrants
• = 60 years of age
• Korean fluency
• no medical history of cognitive impairments (e.g., dementia or Alzheimer-related diseases)
• self-reported direct experience of discrimination as per the Everyday Discrimination Scale

Exclusion Criteria:

• severe cognitive impairment denoting dementia
• other ethnicities rather than Korean Americans/immigrants
• younger than 60 years of age
• cannot speak and read Korean
• have not experienced any discrimination
• serious sensory problems negating the use of virtual reality
• medical history of epilepsy, seizures, or vertigo
• experience in mindfulness or meditation-based programs

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• culturally tailored mindfulness-positive psychological intervention
This 3-week culturally tailored mindfulness-positive psychological intervention instructs techniques to enhance positive emotions and meditation exercise lasting approximately 30 minutes. The culturally tailored mindfulness-positive psychological intervention consists of four modules: 1) noticing positive events, 2) amplifying positive events, 3) gratitude, and 4) mindfulness and meditation. This 3-dimensional software includes gamification features, including a virtual living room, Japanese garden, art gallery, and meditation garden. A private office and/or space was utilized to implement the culturally tailored mindfulness-positive psychological intervention for older Korean Americans/immigrants, provided by the recruitment sites such as non-profit organization and church. The private room at the sites had a desktop (or laptop) computer, a virtual reality device (Oculus Quest 2), a chair, and a desk.

Locations

Country	Name	City	State
United States	Hanul Family Alliance	Chicago	Illinois
United States	Xilin Association	Chicago	Illinois
United States	Christ Community Church at the Square	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic variables	Demographic variables include age, sex, income level, years living in the U.S., education years, employment status, marital status, and health insurance.	Pretest (baseline)
Other	Intervention feasibility	Feasibility consists of recruitment rates (potential participants who were approached for recruitment), enrollment rates (=20% of participants who decide to enroll), retention/attrition rates (goal: 70% of participants who completed the post-intervention assessment, answering Yes/No), and (non)compliance or adherence rates.	posttest (3 weeks later)
Primary	Racism-related stress	The primary outcome is the racism-related stress measured by vicarious racism. Vicarious racism involves seven items that measure the frequency of hearing about or seeing other people of the same racial group experiencing racism: 1) in public or 2) in the news, 3) from romantic partners or, 4) friends and family members, 5) heard by politicians and 6) other public figures, and 7) seeing racist posts on social media during the Coronavirus Disease 2019 pandemic: 0 (never) - 5 (every day). Regarding racism-related stress, participants answer three questions: 1) the degree to which participants thought about these experiences (0 [never] - 4 [always]) and 2) how distressed, and 3) concerned they were about these experiences (0 [not at all] - 4 [extremely]; Cronbach's alpha = 0.89).	Pretest (baseline) and posttest (3 weeks later)
Secondary	Perceived stress	Perceived stress is measured by the Perceived Stress Scale 4, which asks a 4-items about how often the participants felt or thought a certain way during the last month, given a five-point scale: 0 (never) - 4 (very often). Previous studies have indicated that internal consistency reliability of the Korean version was 0.82 (Cronbach's alpha).	Pretest (baseline) and posttest (3 weeks later)
Secondary	Optimism	Optimism is assessed using the Life Orientation Test-Revised, where respondents report their own feelings to measure individual differences in generalized optimism and pessimism. The Life Orientation Test-Revised consists of 3 optimism items, 3 pessimism items (reverse code), and 3 filler items (exclusion from the total scores. Given each item is presented on a 5-point scale (0 = I disagree a lot; 4 = I agree a lot), the total score ranges from 0 (least optimistic) to 24 (most optimistic; Cronbach's alpha = 0.72 - 0.78). Internal consistency reliability of the Korean version of the Life Orientation Test-Revised was 0.81 (Cronbach's alpha).	Pretest (baseline) and posttest (3 weeks later)
Secondary	Positive affect	Positive affect will be derived using the four positively worded items of the Center for Epidemiological Studies Depression Scale as follows: 1) I felt that I was just as good as other people, 2) I felt hopeful about the future, 3) I was happy, and 4) I enjoyed life. The sum of the four items ranges from 0 to 12. Reliability measured by internal consistency for the Korean version of the Center for Epidemiological Studies Depression Scale was 0.89 (Cronbach's alpha) in a previous publication.	Pretest (baseline) and posttest (3 weeks later)
Secondary	Life engagement	The Life Engagement Test is a 5-point Likert scale measuring participants' life engagement. The Life Engagement Test consists of six items as a continuous variable, but three items are reverse-coded so that higher scores indicate better life engagement. Possible responses for all questions are from 1 (strongly disagree) to 5 (strongly agree). There is no previous study that tested the reliability of older Korean adults. However, another study indicates a Cronbach's alpha of 0.84.	Pretest (baseline) and posttest (3 weeks later)
Secondary	Mindful attention awareness	The Mindful Attention Awareness Scale consists of 15 questions to measure dispositional mindfulness characteristics. The sample questions are: The Mindful Attention Awareness Scale is a continuous variable with response options ranging from 1 (almost always) to 6 (almost never). Previous studies used the Mindful Attention Awareness Scale for Koreans, and its internal consistency reliability ranges from 0.87 to 0.95 (Cronbach's alpha).	Pretest (baseline) and posttest (3 weeks later)
Secondary	Everyday discrimination	The Everyday Discrimination Scale measures the magnitude of unfair treatment in ongoing and routine experiences in daily life. The Everyday Discrimination Scale involves a nine-item scale with a six-point Likert scale: 0 (never) - 5 (almost every day). Its internal consistency reliability (Cronbach's alpha) according to previous studies targeting various ethnicities (e.g., White, Black, Hispanic/Latino, and Asian) was 0.88 (Cronbach's alpha).	Pretest (baseline)
Secondary	Virtual reality safety	The Simulator Sickness Questionnaire was developed to measure cybersickness symptoms in virtual reality research. The Simulator Sickness Questionnaire measures three domains (e.g., nausea, oculomotor, and disorientation) assessed through weighting 16 symptoms of cyber sickness. The measure is scored using a 4-point scale and weighted according to each factor to calculate the total score. Internal consistency reliability of the Simulator Sickness Questionnaire (Cronbach's alpha) was 0.94.	After every sessions (1 week later, 2 weeks later, 3 weeks later)
Secondary	Technology acceptance	Participants answer the scales involving perceived ease of use, perceived usefulness, and attitude toward using virtual reality, with a 5-point Likert scale (1: strongly disagree; 5: strongly agree).	After every sessions (1 week later, 2 weeks later, 3 weeks later)
Secondary	Patient-Reported Outcomes Measurement Information System Bank v1.0 - Anxiety	The Patient-Reported Outcomes Measurement Information System Bank v1.0 - Anxiety consists of 4 questions to measure anxiety levels. This measurement ranges from 1 (never) to 5 (always).	Pretest (baseline) and posttest (3 weeks later)
Secondary	Patient-Reported Outcomes Measurement Information System Bank v1.0 - Depression	The Patient-Reported Outcomes Measurement Information System Bank v1.0 - Depression consists of 4 questions to measure depressive symptom levels. This measurement ranges from 1 (never) to 5 (always).	Pretest (baseline) and posttest (3 weeks later)