Clinical trial NCT04961242: Pilot Evaluation of Together for Wellness Website in COVID-19
Official title: Pilot Evaluation of Together for Wellness Website in COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digital Mental Health Resources (Website) for Coping With Stress and Information
Keywords: digital mental health resources, website, user feedback and evaluation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: California Department of Health Services
name: University of California, Davis
First posted: 2021-07-14
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (\>=18) that partner with agencies participating across California in the evaluation of the Together for Wellness website, and voluntarily agree to participate. This will include community members, community leaders, case managers and crisis counselors, and clients of agencies.

Brief summary: This is a pilot evaluation of a set of free digital mental health resources developed for COVID-19 relief in California, with funding for the evaluation by the California Health Care Foundation. The website includes resources to support information on COVID-19, meditation and stress management, resources for parenting resilience, resources for social connection and addressing structural racism, and linkages to resources under the partnering "CalHOPE" website (FEMA funded). The evaluation includes: 1) an invitation from a partnering agency to visit the website and consider the evaluation; 2) a post website visit baseline survey; 3) a follow-up survey 4-6 weeks later; 4) a telephone interview for a subset of participants who agree to the follow-up interview and provide their contact information.

Detailed description: Relevance:

The COVID-19 pandemic has raised awareness of mental health as a primary public health concern. Physical distancing, business and school closures, grief, and stress are aspects of the pandemic with significant mental health consequences. The pandemic has also disproportionately impacted Black, Asian and Pacific Islander, Indigenous, and Latino populations. Concurrent with the pandemic has been a surge in attention on police violence toward Black Americans as well as systemic racism against other groups (Asian) and in other institutions. These stressors are also likely to have substantial mental health consequences. To support addressing these concerns, the state requested development of a website (Together for Wellness) with input from stakeholders across the state, to support dealing with informational needs and stress of diverse stakeholders across the state. In addition, a goal was to obtain user feedback data to understand impact of the website Below are aims for the initial survey, qualitative interview for a subsample, and follow-up survey.

Specific Aims for Initial Survey:

Specific Aim 1: To understand the subjective value of a website of free mental health resources for users of various ethnicities, ages, and who may differ in baseline mental health status and use of mental health services.

Specific Aim 2: To understand the subjective value of a website of free mental health resources for users with various degrees of COVID-related stress.

Specific Aims for Qualitative Interviews:

The broad goal is to use qualitative interviews to more deeply understand the experiences of participants in reviewing the website, their needs for support for themselves, family or community, and ideas for further development of the website. The qualitative interview data will also be linked to their survey data and google analytics data, and de-identified.

Specific Aim 3: To understand the experiences of users who reviewed the website of free mental health resources, using a semi-structured interview guide to examine responses to the website, their needs for support for themselves, family or community, and ideas for improving the website.

Specific Aim 4: To understand how subjective experiences may vary across website users, and to gain insight from participants from various strata (e.g., various race/ethnicity groups, those who live in urban and rural locations, those with various levels of COVID-related stress, and people of different age groups and different gender identities, or other demographics). With stakeholder input, we will select priorities for stratification of sampling (and may increase the number of interviews conducted based on resources available to partnering stakeholder groups through existing contracts that some agencies have with the Mental Health Services Oversight and Accountability Commission).

Specific Aims for Follow-up Survey:

The goal of the follow-up survey, to be conducted 4-6 weeks after patients have completed their initial website review and their initial survey, is to explore impacts in terms of use of services, and effects on mental health stigma and brief measures of stress/anxiety, and provide follow-up information on mediating factors such as experience of stress including with the COVID-19 pandemic. The follow-up survey will provide evaluative data on somewhat longer-term impact than the immediate quantitative survey.

Specific Aim 5: To understand the experience of users who reviewed the website of free mental health resources, 4-6 weeks after their initial survey.

Specific Aim 6: To understand any associations of experience of the website with mental health stigma items, and use of services; as well as any continued use of the website resources; and explore changes in risk for depression and anxiety (PHQ2 and GAD2) and context for stresses due to the COVID-19 pandemic.

Linkage to Survey and Google Analytics Data for follow-up survey Survey data will also be linked to respondents' initial survey and google analytics data, to understand the context of website use and user characteristics for the sample.

Eligibility criteria: Inclusion Criteria: Participants must be:

* 18 years or older by self-report
* able to access the internet on their own
* able to complete a written survey in English or Spanish.
* They must be invited by a partnering agency within the limit allowed to that agency (30-40 participants).

Exclusion Criteria:

* Age under 18 by self-report
* inability to read and understand either English or Spanish
* not having access online (not a specific survey question).
* Not able to complete survey in English or Spanish;
* Referring stakeholder group has already had 30-40 participants enroll.

Primary outcomes:
measure: Patient Health Questionnaire-2 item (PHQ-2)
timeFrame: change from baseline to 4-6 weeks follow-up
measure: Generalized Anxiety Disorder-2 items (GAD-2)
timeFrame: change from baseline to 4-6 weeks follow-up
Secondary outcomes:
measure: Stigma toward mental health
timeFrame: change from baseline to 4-6 weeks follow-up
measure: Behavioral Health Services Use
timeFrame: Change from baseline to 4-6 weeks follow-up
measure: COVID-related Stressors
timeFrame: Change from baseline to 4-6 weeks follow-up
measure: Race/ethnicity discrimination
timeFrame: Change from baseline to 4-6 weeks follow-up
measure: vaccination status and acceptability
timeFrame: Change from baseline to 4-6 weeks follow-up
measure: perceived value of website
timeFrame: Change from baseline to 4-6 week follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Jane and Terry Semel Institute for Neuroscience and Human Behavior, Center for Health Services and Society
state: California
Study officials:
affiliation: UCLA School of Nursing
name: MarySue Heilemann, PhD
role: STUDY_DIRECTOR
References:
citation: Wells K, Thames AD, Young AS, Zhang L, Heilemann MV, Romero DF, Oliva A, Jones F, Tang L, Brymer M, Elliott T, Arevian A; Together for Wellness/Juntos Collaborators and Writing Group. Engagement, Use, and Impact of Digital Mental Health Resources for Diverse Populations in COVID-19: Community-Partnered Evaluation. JMIR Form Res. 2022 Dec 7;6(12):e42031. doi: 10.2196/42031.