Mental Health IssueNCT06019416
Culturally Tailored Mindfulness-Positive Psychological Intervention Using Virtual Reality
A study testing culturally tailored mindfulness-positive psychological intervention in people with Mental Health Issue, run by University of Illinois at Urbana-Champaign at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- culturally tailored mindfulness-positive psychological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jan 2023to 19 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Xilin Association
Chicago, Illinois, 60005
Hanul Family Alliance
Chicago, Illinois, 60625
Christ Community Church at the Square
Urbana, Illinois, 61822
About this study
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
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).
- Conditions
- Mental Health Issue
- Being tested
- culturally tailored mindfulness-positive psychological intervention
- Keywords
- Virtual reality, Mindfulness, Well-being, Anti-Asian Racism, Positive psychological intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culturally tailored mindfulness-positive psychological interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | As the intervention group, the participants should participate in three weekly scheduled mindfulness-positive psychological intervention sessions using virtual reality for 15 - 20 minutes per session. Receives: Behavioral: culturally tailored mindfulness-positive psychological intervention |
| Waitlist group | No intervention | As the waitlist group, no treatment was given to the participants, while the intervention group participated in the mindfulness-positive psychological intervention for three weeks. After the three-week waiting period, the participants were contacted and asked to complete the post-measurements. After completion, the participants started with the three-week mindfulness-positive psychological intervention using virtual reality for 15 - 20 minutes. No further data was obtained from these participants after the completion of the program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pretest (baseline) and posttest (3 weeks later)
Secondary outcomes (10)
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).
Measured: Pretest (baseline) and posttest (3 weeks later)
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).
Measured: Pretest (baseline) and posttest (3 weeks later)
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.
Measured: Pretest (baseline) and posttest (3 weeks later)
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.
Measured: Pretest (baseline) and posttest (3 weeks later)
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).
Measured: Pretest (baseline) and posttest (3 weeks later)
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).
Measured: Pretest (baseline)
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.
Measured: After every sessions (1 week later, 2 weeks later, 3 weeks later)
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).
Measured: After every sessions (1 week later, 2 weeks later, 3 weeks later)
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).
Measured: Pretest (baseline) and posttest (3 weeks later)
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).
Measured: Pretest (baseline) and posttest (3 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start31 Jan 2023
- Primary completion1 Feb 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group will receive the virtual reality-based culturally tailored mindfulness and positive psychological intervention, whereas the control group will not receive any intervention as a waitlist group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soonhyung Kwon, MSW, MA, Principal investigator, University of Illinois Urbana-Champaign, School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019416
- Sponsor's protocol ID
- 23430
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a dissertation project. This study data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06019416
- Acronym / sponsor ID
- 23430
- Conditions
- Mental Health Issue
- Keywords
- Virtual reality, Mindfulness, Well-being, Anti-Asian Racism, Positive psychological intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention group will receive the virtual reality-based culturally tailored mindfulness and positive psychological intervention, whereas the control group will not receive any intervention as a waitlist group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: culturally tailored mindfulness-positive psychological interventionAs the intervention group, the participants should participate in three weekly scheduled mindfulness-positive psychological intervention sessions using virtual reality for 15 - 20 minutes per session. |
| Waitlist group | No intervention | –As the waitlist group, no treatment was given to the participants, while the intervention group participated in the mindfulness-positive psychological intervention for three weeks. After the three-week waiting period, the participants were contacted and asked to complete the post-measurements. After completion, the participants started with the three-week mindfulness-positive psychological intervention using virtual reality for 15 - 20 minutes. No further data was obtained from these participants after the completion of the program. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| culturally tailored mindfulness-positive psychological interventionThis 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. | Behavioural | Intervention group |
Primary outcome
Racism-related stress
Time frame: Pretest (baseline) and posttest (3 weeks later)
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).
10 secondary outcomes
Perceived stress
Time frame: Pretest (baseline) and posttest (3 weeks later)
Optimism
Time frame: Pretest (baseline) and posttest (3 weeks later)
Positive affect
Time frame: Pretest (baseline) and posttest (3 weeks later)
Life engagement
Time frame: Pretest (baseline) and posttest (3 weeks later)
Mindful attention awareness
Time frame: Pretest (baseline) and posttest (3 weeks later)
Everyday discrimination
Time frame: Pretest (baseline)
Virtual reality safety
Time frame: After every sessions (1 week later, 2 weeks later, 3 weeks later)
Technology acceptance
Time frame: After every sessions (1 week later, 2 weeks later, 3 weeks later)
Patient-Reported Outcomes Measurement Information System Bank v1.0 - Anxiety
Time frame: Pretest (baseline) and posttest (3 weeks later)
Patient-Reported Outcomes Measurement Information System Bank v1.0 - Depression
Time frame: Pretest (baseline) and posttest (3 weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No. This is a dissertation project. This study data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soonhyung Kwon, MSW, MA principal investigator
University of Illinois Urbana-Champaign, School of Social Work
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing culturally tailored mindfulness-positive psychological intervention in people with Mental Health Issue, run by University of Illinois at Urbana-Champaign at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Racism-related stress (time frame: Pretest (baseline) and posttest (3 weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.