An interventional study of INFORMED-Living Well and Text Messaging Only in COVID-19 and Well-Being, Psychological, sponsored by University of California, San Francisco. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Other
The project is to facilitate pandemic recovery by promoting emotional wellness among Asian Californians. The intervention includes a 6-week program in which participants may choose to receive text only or text + Lay Health Worker outreach targeting 600 self-identified Asian Americans residing in California who speak/read English, Chinese, Korean, Hmong, or Vietnamese.
Investigators will conduct a non-randomized intervention trial (preference trial). Research participants involved in the trial will include 20 lay health workers (LHWs) and 600 trial participants with intervention delivered via SMS text messaging (for all participants), and the intervention group will receive educational intervention outreach from an LHW via Zoom or mutually agreed video conferencing online venues, and by telephone or instant messaging. Participants will choose which group they are in, SMS text messaging only or SMS text messaging plus educational outreach from an LHW.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
i) age 18 and older
ii) speak Chinese, English, Hmong, Korean, or Vietnamese
iii) self-identify as Asian American
iv) have access to a mobile phone to receive SMS text messages
Exclusion Criteria:
INFORMED-Living Well consists of two components: 1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging. The LHW educational outreach component includes 2 small group educational sessions with 2-8 participants. Participants will also receive a weekly SMS Text or instant message on managing emotional wellness within and beyond the context of the COVID-19 pandemic over 6 weeks. In addition, participants will receive as-needed messages on updates of COVID-19 or other situations that may introduce new worries and tragic culturally-based traumatic events.
Behavioral: INFORMED-Living Well
Participants will have a 6-week SMS text messaging program identical to that received by the INFORMED-Living Well participants.
Behavioral: Text Messaging Only
1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging
A 6-week automated SMS text messaging
Change in decisional conflict scale (SURE) scores
Self-assessed perceptions of decision conflict will be assessed using the 4-item Decision Conflict Scale (SURE). Scores on the SURE scale range from 0 to 4, with higher scores indicating less decisional conflict. A score of less than 4 indicates decisional conflict.
Time frame: Baseline and 8-week follow-up
Change in proportion of participants who have Intention to seek help for mental health
We will use a survey item to assess participants' intention to seek help for mental health issues when needed. A response will be 0 (No) or 1 (Yes).
Time frame: Baseline and 8-week follow-up
Change in self-reported emotional wellness outcome
We will use the four-item Patient Health Questionnaire (PHQ4) for measuring anxiety and depression symptoms. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score 3 or higher for the first 2 questions suggests anxiety, and total score 3 or higher for the last 2 questions suggests depression.
Time frame: Baseline and 8-week follow-up
Change in the percentage of participants' awareness of resources to get help or to learn more about improving emotional wellness
We will assess participants' awareness of resources to get help or to learn more about improving emotional wellness. Two items created for the study will be used: 1) Do you know about "988"? (Yes, No, Unsure) 2) Do you know where to get help for mental health issues when you need to? (Yes, No, Unsure). The percentage of participants who answer "yes" to both questions will be assessed.
Time frame: Baseline and 8-week follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco