Pilot Evaluation of Together for Wellness Website in COVID-19 ((T4W))

January 9, 2023 updated by: Kenneth B. Wells, University of California, Los Angeles
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Jane and Terry Semel Institute for Neuroscience and Human Behavior, Center for Health Services and Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-2 item (PHQ-2)
Time Frame: change from baseline to 4-6 weeks follow-up
Screener for depressive disorder
change from baseline to 4-6 weeks follow-up
Generalized Anxiety Disorder-2 items (GAD-2)
Time Frame: change from baseline to 4-6 weeks follow-up
Screener for generalized anxiety disorder
change from baseline to 4-6 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stigma toward mental health
Time Frame: change from baseline to 4-6 weeks follow-up
2-item measure (5 agree to disagree categories plus don't know)
change from baseline to 4-6 weeks follow-up
Behavioral Health Services Use
Time Frame: Change from baseline to 4-6 weeks follow-up
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
Change from baseline to 4-6 weeks follow-up
COVID-related Stressors
Time Frame: Change from baseline to 4-6 weeks follow-up

Pandemic stress index (adapted):

Overall impact (5 categories plus not answer); experience of stressors (18 plus other)
Change from baseline to 4-6 weeks follow-up
Race/ethnicity discrimination
Time Frame: Change from baseline to 4-6 weeks follow-up
race/ethnicity discrimination measure (6 items on 4-point agree scale)
Change from baseline to 4-6 weeks follow-up
vaccination status and acceptability
Time Frame: Change from baseline to 4-6 weeks follow-up
vaccination status (yes/no) and acceptability (5 category agree, plus don't know)
Change from baseline to 4-6 weeks follow-up
perceived value of website
Time Frame: Change from baseline to 4-6 week follow-up

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
Change from baseline to 4-6 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

University of California, Davis
California Department of Health Services

Investigators

  • Study Director: MarySue Heilemann, PhD, UCLA School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Actual)

May 17, 2022

Study Completion (Actual)

January 7, 2023

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-002163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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