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Mobile Health App for COVID-19 Management
N/A
Waitlist Available
Research Sponsored by University of Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-month follow-up, 6-month follow-up
Awards & highlights
Study Summary
This trial will compare the effectiveness of a mobile app called EASE, which provides COVID-19 symptom monitoring, exposure management skills, and psychoeducation on stress, to an empirical measurement of standard-of-care digital intervention. The study also aims to identify the effective mechanisms in EASE.
Who is the study for?
This trial is for adults over 18 living in Texas or Oklahoma who identify as Black, Latinx, American Indian, or non-Latinx White and have significant anxiety or depression. Participants must be able to use a smartphone app for six months and complete follow-ups via another app and phone interviews. People not fluent in English or with cognitive impairments can't join.Check my eligibility
What is being tested?
The study tests the EASE mobile app designed to monitor COVID-19 symptoms, manage exposure, and educate on stress's impact on health against a standard digital intervention (INSIGHT App). It aims to see if EASE can improve mental health among diverse populations during the pandemic.See study design
What are the potential side effects?
Since this trial involves using mobile apps rather than medication, traditional side effects are not expected. However, users may experience discomfort from regular engagement with content related to their mental health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-month follow-up, 6-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-month follow-up, 6-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Screener in anxiety on the 5-item Overall Anxiety Severity and Impairment Scale at follow-up appointments.
Change from Screener in depression on the 5-item Overall Depression Severity and Impairment Scale at subsequent follow-up appointments.
Anxiety
Secondary outcome measures
Acculturation
Anxiety Sensitivity
Discrimination Burden
+5 moreOther outcome measures
A qualitative interview will be used to evaluate the mobile app for style and presentation, perceived utility, ease of use, usefulness of features, and willingness to refer to a friend.
The COVID-19 Substance Use scale will be used to gain a granular understanding of the health behaviors (i.e. substance use) affected by COVID-19 among those who do and do not contract the virus.
The Employment Status questionnaire will be used to obtain a granular understanding of the sequelae (e.g., job loss, eviction, reduction of unemployment benefits) of the COVID-19 pandemic among those who do and do not contract the virus.
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: INSIGHT (Control) APPExperimental Treatment1 Intervention
The Insight app provides users with educational videos on mindfulness and meditation techniques.
Group II: EASE AppExperimental Treatment1 Intervention
EASE is a intervention designed to address anxiety and depression symptoms in its users through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress.
Find a Location
Who is running the clinical trial?
University of HoustonLead Sponsor
147 Previous Clinical Trials
46,728 Total Patients Enrolled
University of OklahomaOTHER
455 Previous Clinical Trials
96,786 Total Patients Enrolled
Oklahoma State UniversityOTHER
46 Previous Clinical Trials
7,448 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years old or older.You are Black, Latinx, American Indian, or non-Latinx white.You have severe anxiety or depression based on a specific scale.You are willing/able to complete EMAs on study provided or personal smartphone for 6-month study period.You have a long-term or serious problem with thinking or understanding.You have high scores on tests that show you have significant anxiety and/or depression symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: INSIGHT (Control) APP
- Group 2: EASE App
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression and Anxiety Patient Testimony for trial: Trial Name: NCT05074693 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the expected outcomes of this research project?
"The primary purpose of this trial, lasting for up to 6 months, is to observe changes in depression-related impairment on the 5-item Overall Depression Severity and Impairment Scale. This will be complemented by secondary goals including the assessment of Subjective Social Status through the MacArthur Scale of Subjective Social Status, analyzing alterations in perceived racial bias/discrimination due to COVID-19 with the Coronavirus Racial Bias Scale (CRBS) , and evaluating fluctuations in social support as assessed by Perceived Social Support Questionnaire (F-SozU K-6)."
Answered by AI
How many people can participate in this trial at its fullest capacity?
"Affirmative. According to data on clinicaltrials.gov, this trial is actively seeking participants and was initially posted on December 20th 2021 with the most recent update taking place on September 19th 2022. 800 patients in total must be recruited from 3 distinct study sites."
Answered by AI
Are there still spots available for individuals to participate in this medical trial?
"Indeed, the details on clinicaltrials.gov verify that this clinical trial is presently enrolling participants. The protocol was originally published in December 2021 and revised last month (September 2022). 800 volunteers are needed for 3 research centres."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
Anxiety and Health Research Lab / Substance Use Treatment Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
3+
Why did patients apply to this trial?
I'm very interested. I want to rid of depression & anxiety I've been experiencing for years.
PatientReceived no prior treatments
I'm highly interested in the study and advancement of metal health awareness of the African American community.
PatientReceived 1 prior treatment
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