Trial Outcomes & Findings for Mobile Health and COVID-19 (NCT NCT05074693)

Results Overview

Changes in reported anxiety and depression related impairment experienced in major life sectors (work performance, household maintenance, social interactions, relationships) as measured by study developed items from Baseline to follow-up assessments. This measure was created by the study team and was 4 items rated from 1 (Strongly disagree) to 5 (Strongly agree). The scale is summed for a total score with ranges from 4 to 25, with higher scores indicating greater everyday impairment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

822 participants

Primary outcome timeframe

From Baseline to 6-Months

Results posted on

2025-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	EASE App 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. EASE app: EASE is a mobile intervention designed to reduce ongoing mental health concerns among BLAI individuals with elevated anxiety and/or depressive symptoms by targeting anxiety sensitivity. The EASE app employs a variety of features to educate its users on how to deal with increased levels of stress, anxiety, and depression, and train users on how to better cope with the negative feelings of stress. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos designed to teach participants how to better deal with stress. EASE also utilizes Ecological Momentary Assessments (EMAs) to gather information, and provide personalized messages to users in real time. Finally, EASE is outfitted with COVID-19 related elements, including a symptoms tracker (which participants can use to report symptoms of COVID-19 they may be experiencing), and a collection of COVID-19 related food, housing, and job placement resources.	INSIGHT (Control) APP The Insight app provides users with educational videos on mindfulness and meditation techniques. INSIGHT (Control) App: A standard of care control intervention was developed using the INSIGHT platform. This app contains a library of educational videos that cover topics such as meditation and mindfulness, as well as general stress reduction techniques. Additionally, participants have access to a "Report Distress" feature that enables them to report moments when they are feeling high levels of stress. Finally, participants will be able to report any COVID-19 related symptoms they experience using a COVID-19 symptom tracker feature. Participants assigned to this condition will received 2 daily EMAs, during which they will be prompted to watch one of the aforementioned educational videos.
Overall Study STARTED	413	409
Overall Study COMPLETED	413	409
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EASE App n=413 Participants 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.	INSIGHT (Control) APP n=409 Participants The Insight app provides users with educational videos on mindfulness and meditation techniques.	Total n=822 Participants Total of all reporting groups
Age, Continuous	38.63 Years STANDARD_DEVIATION 13.0 • n=5 Participants	38.05 Years STANDARD_DEVIATION 12.5 • n=7 Participants	38.34 Years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	269 Participants n=5 Participants	262 Participants n=7 Participants	531 Participants n=5 Participants
Sex: Female, Male Male	144 Participants n=5 Participants	147 Participants n=7 Participants	291 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	104 Participants n=5 Participants	98 Participants n=7 Participants	202 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	309 Participants n=5 Participants	311 Participants n=7 Participants	620 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	103 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	105 Participants n=7 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	208 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.
Race (NIH/OMB) Asian	0 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	0 Participants n=7 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	0 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	0 Participants n=7 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	0 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.
Race (NIH/OMB) Black or African American	103 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	103 Participants n=7 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	206 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.
Race (NIH/OMB) White	103 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	103 Participants n=7 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	206 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	0 Participants n=7 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	0 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.
Race (NIH/OMB) Unknown or Not Reported	104 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	98 Participants n=7 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.	202 Participants n=5 Participants • The analyzed row differs from the Overall because Hispanic or Latino was our fourth racial and ethnic group examined. In total, we analyzed 4 groups: American Indians, Black or African Americans, White, and Hispanic or Latino.

PRIMARY outcome

Timeframe: From Baseline to 6-Months

Changes in reported anxiety and depression related impairment experienced in major life sectors (work performance, household maintenance, social interactions, relationships) as measured by study developed items from Baseline to follow-up assessments. This measure was created by the study team and was 4 items rated from 1 (Strongly disagree) to 5 (Strongly agree). The scale is summed for a total score with ranges from 4 to 25, with higher scores indicating greater everyday impairment.

Outcome measures

Outcome measures
Measure	EASE App n=413 Participants 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.	INSIGHT (Control) APP n=409 Participants The Insight app provides users with educational videos on mindfulness and meditation techniques.
Everyday Impairment Everyday Impairment at Baseline	15.65 Scores on a scale Standard Deviation 2.84	15.47 Scores on a scale Standard Deviation 2.91
Everyday Impairment Everyday Impairment at 6-month	12.74 Scores on a scale Standard Deviation 4.54	13.23 Scores on a scale Standard Deviation 4.40

PRIMARY outcome

Timeframe: From Screener to 6-Months

Change from Screener in anxiety on the 5-item Overall Anxiety Severity and Impairment Scale (OASIS) at follow-up appointments. The OASIS is made up of 5 items rated on a scale from 0 to 4. The OASIS is summed for a total score, with a range from 0 to 25, with higher scores indicating higher anxiety severity and impairment.

Outcome measures

Outcome measures
Measure	EASE App n=413 Participants 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.	INSIGHT (Control) APP n=409 Participants The Insight app provides users with educational videos on mindfulness and meditation techniques.
Anxiety Anxiety at Baseline	10.63 Total Score Interval 10.3 to 10.95	10.84 Total Score Interval 10.5 to 11.18
Anxiety Anxiety at 6-months	7.32 Total Score Interval 6.9 to 7.74	7.59 Total Score Interval 7.15 to 8.02

PRIMARY outcome

Timeframe: From Screener to 6-Month

Change from Screener in depression on the 5-item Overall Depression Severity and Impairment Scale (ODSIS) at subsequent follow-up appointments. The ODSIS is made up of 5 items rated on a scale from 0 to 4. The ODSIS is summed for a total score, with a range from 0 to 25, with higher scores indicating higher depression severity and impairment.

Outcome measures

Outcome measures
Measure	EASE App n=413 Participants 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.	INSIGHT (Control) APP n=409 Participants The Insight app provides users with educational videos on mindfulness and meditation techniques.
Depression Depression at 6-month	6.45 Total Score Interval 5.97 to 6.93	6.58 Total Score Interval 6.08 to 7.09
Depression Depression at Baseline	9.74 Total Score Interval 9.34 to 10.15	9.82 Total Score Interval 9.39 to 10.25

SECONDARY outcome

Timeframe: From Baseline to end of study, up to 6 months.

The Everyday Discrimination Scale (EDS) is a six-item scale that assesses perceptions of discrimination or unfair treatment. The EDS will be utilized to explore whether perceived racial discrimination functions as a moderator of treatment effects on the primary outcomes listed as primary outcomes. The EDS is summed for a total score, with a range from 0 to 20. Higher scores indicate greater everyday discrimination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline to end of study, up to 6 months.

The Coronavirus Racial Bias Scale (CRBS) is a brief self-report questionnaire that measures levels of perceived racial bias/discrimination due to the COVID-19 pandemic. The CRBS will be utilized to explore whether perceived racial discrimination due to the COVID-19 pandemic functions as a moderator of the EASE effects. The CRBS will be utilized to explore whether perceived racial discrimination due to the COVID-19 pandemic functions as a moderator of treatment effects on the primary outcomes listed as primary outcomes. The CRBS is a mean score, with higher scores indicating greater coronavirus racial bias.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline to end of study, up to 6 months.

The Perceived Social Support Questionnaire (F-SozU K-6) is a measure of the perceived social support. The F-SozU K-6 is summed for a total score, with a range from 6 to 24. Higher scores indicate greater degrees of social support. The F-SozU K-6 will be utilized to explore whether social support functions as a moderator of the treatment effects on the primary outcomes listed as primary outcomes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline to end of study, up to 6 months.

The MacArthur Scale of Subjective Social Status is a measures of perceived social status. The MSSS will be utilized to explore whether perceived social status functions as a moderator of the treatment effects on the primary outcomes listed as primary outcomes. The MSSS is not score but has a range from 0 to 10.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to end of study, up to 6 months.

The Short Scale Anxiety Sensitivity Index (SSASI) will be used to explore whether Intervention effects on study outcomes are mediated by reductions in anxiety sensitivity. The SSASI is a total score with a range from 0 to 20, with higher scores indicating greater anxiety sensitivity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline to end of study, up to 6 months.

The discrimination burden section of the Jackson Heart Study Discrimination Instrument will be used to measure perceived experience of discrimination. The measure is a total score with ranges from 4 to 12. Higher scores indicate higher difficulty living a productive and full life because of perceived experience of discrimination. This measure will be used to assess whether discrimination burden functions as a moderator of the EASE effects.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to end of study, up to 6 months.

The Fear of COIVD-19 scale will be used to explore whether intervention effects on study primary outcomes are mediated by reductions in fear related to the COVID-19 pandemic. The FCV is summed for a total score with a range from 5 to 25. Higher scores indicate greater fear of COVID-19.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

The Abbreviated Multidimensional Acculturation Scale (AMAS) assesses an individual's level of acculturation to a host culture. The AMAS is a mean score. For questions that ask participants how strongly they feel apart of U.S. culture, higher scores indicate higher levels of acculturation. For questions that ask about their future of origin, higher score indicate lower levels of acculturation. This measure will be used to assess whether acculturation functions as a moderator of the EASE effects

Outcome measures

Outcome data not reported

Adverse Events

EASE App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

INSIGHT (Control) APP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Zvolensky, Ph.D.

University of Houston

Phone: 713-743-8056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place