Digital Mental Health Resources (Website) for Coping With Stress and Information(T4W)NCT04961242
Pilot Evaluation of Together for Wellness Website in COVID-19
An observational study of Digital Mental Health Resources (Website) for Coping With Stress and Information, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digital Mental Health Resources (Website) for Coping With Stress and Information
- What is being tested?
- Together for Wellness digital mental health website
- Type of treatment
- Medical device
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 7 Jan 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Jane and Terry Semel Institute for Neuroscience and Human Behavior, Center for Health Services and Society
Los Angeles, California, 90024
About this study
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.
Read the 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.
- Being tested
- Together for Wellness digital mental health website
- Keywords
- digital mental health resources, website, user feedback and evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Together for Wellness digital mental health websiteDevice
The intervention is a digital mental health resources website that includes multiple, free resources for broad public use. Different categories of resources include information on COVID-19 from CDC, multi-language versions of the UCLA Mindfulness App and other meditation programs, resources for families and social connection, including addressing discrimination or equity, and resource links.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-2 item (PHQ-2)
Screener for depressive disorder
Measured: change from baseline to 4-6 weeks follow-up
Generalized Anxiety Disorder-2 items (GAD-2)
Screener for generalized anxiety disorder
Measured: change from baseline to 4-6 weeks follow-up
Secondary outcomes (6)
Stigma toward mental health
2-item measure (5 agree to disagree categories plus don't know)
Measured: change from baseline to 4-6 weeks follow-up
Behavioral Health Services Use
ER use, general medical use, mental health provider use, substance use provider use, hospitalization for behavioral health, residential treatment, hotline use for behavioral health (any, visits/nights/calls if any, for ER use and general medical also visits for behavioral health); -- overall: any use, mean visits and for behavioral health visits
Measured: Change from baseline to 4-6 weeks follow-up
COVID-related Stressors
Pandemic stress index (adapted):
Overall impact (5 categories plus not answer); experience of stressors (18 plus other)
Measured: Change from baseline to 4-6 weeks follow-up
Race/ethnicity discrimination
race/ethnicity discrimination measure (6 items on 4-point agree scale)
Measured: Change from baseline to 4-6 weeks follow-up
vaccination status and acceptability
vaccination status (yes/no) and acceptability (5 category agree, plus don't know)
Measured: Change from baseline to 4-6 weeks follow-up
perceived value of website
Baseline: Satisfaction, ease of use, relevance (4-items, 5 agree categories plus don't know); mean
Follow-up: any use (yes/no); frequency of use/download (4 categories); use and value of 6 resources areas (any use; 4 categories of value if used); recommended site to others (yes/no; how many times open ended; which categories of 6- any use (0/1) frequency (count) and by category
Measured: Change from baseline to 4-6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start20 Sep 2021
- Primary completion17 May 2022
- Study completion7 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digital Mental Health Resources (Website) for Coping With Stress and InformationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- California Department of Health Services, University of California, Davis
- Responsible party
- Principal investigator, Kenneth B. Wells, University of California, Los Angeles
- Investigators
- MarySue Heilemann, PhD, Study director, UCLA School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961242
- Sponsor's protocol ID
- 20-002163
- Acronym
- (T4W)
- Status last verified
- Jan 2023
- First submitted
- 1 Jul 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be deidentified and linked by code number; we will be deciding whether deidentified data will be available to other investigators from this pilot study.
Publications
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.
PubMed 36346902
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Together for Wellness Website in COVID-19
- ClinicalTrials.gov ID
- NCT04961242
- Acronym / sponsor ID
- (T4W) / 20-002163
- Keywords
- digital mental health resources, website, user feedback and evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- California Department of Health Services, University of California, Davis
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 7 Jan 2023 (actual)
- First posted
- 14 Jul 2021 (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 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Together for Wellness digital mental health websiteThe intervention is a digital mental health resources website that includes multiple, free resources for broad public use. Different categories of resources include information on COVID-19 from CDC, multi-language versions of the UCLA Mindfulness App and other meditation programs, resources for families and social connection, including addressing discrimination or equity, and resource links. | Device | – |
Primary outcome
Patient Health Questionnaire-2 item (PHQ-2)
Time frame: change from baseline to 4-6 weeks follow-up
Screener for depressive disorder
Generalized Anxiety Disorder-2 items (GAD-2)
Time frame: change from baseline to 4-6 weeks follow-up
Screener for generalized anxiety disorder
6 secondary outcomes
Stigma toward mental health
Time frame: change from baseline to 4-6 weeks follow-up
Behavioral Health Services Use
Time frame: Change from baseline to 4-6 weeks follow-up
COVID-related Stressors
Time frame: Change from baseline to 4-6 weeks follow-up
Race/ethnicity discrimination
Time frame: Change from baseline to 4-6 weeks follow-up
vaccination status and acceptability
Time frame: Change from baseline to 4-6 weeks follow-up
perceived value of website
Time frame: Change from baseline to 4-6 week follow-up
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 11 Jan 2023.
- Results publication: PubMed 36346902Wells 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.
- Individual participant dataSharing planned: No. The data will be deidentified and linked by code number; we will be deciding whether deidentified data will be available to other investigators from this pilot study.
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.
MarySue Heilemann, PhD study director
UCLA School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digital Mental Health Resources (Website) for Coping With Stress and Information, run by University of California, Los Angeles at 1 site 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 4 inclusion and 5 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 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Patient Health Questionnaire-2 item (PHQ-2) (time frame: change from baseline to 4-6 weeks follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961242, which also lists 1 linked publication.
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 11 Jan 2023.