HealthyNCT05498207
Identification of Biomarkers for Stress Vulnerability and Resilience
A study testing Maya App in people with Healthy, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this research study is to understand the biological mechanisms of stress vulnerability (being susceptible to stress) and stress resilience (being able to recover readily from stress), obtain biomarkers (a biological indicator) for stress resilience and to devise strategies for prevention and treatment… Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Maya App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Incoming Freshmen Students at the University of Michigan
Who cannot join
- Suicidal Ideation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Virginia Weinberg, 734-936-4820, gweinber@umich.edu
Huda Akil, PhD
About this study
The purpose of this research study is to understand the biological mechanisms of stress vulnerability (being susceptible to stress) and stress resilience (being able to recover readily from stress), obtain biomarkers (a biological indicator) for stress resilience and to devise strategies for prevention and treatment of stress-related disorders.
Read the detailed description
This study will be using the Maya application (app) for the intervention arm, a mobile cognitive behavior therapy (CBT) program for adolescents and young adults experiencing anxiety symptoms. The Maya app, developed at Weill Cornell, teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.
- Conditions
- Healthy
- Being tested
- Maya App
- Keywords
- Mental Health, Mobile application, Cognitive Behavioral Therapy (CBT), Stress, Fitbit
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maya AppBehavioural
Participants will utilize the Maya App for at least 20 minutes per day, 2 days per week, for 6 weeks. Additionally, participants will complete assessments at baseline, 3 months, 6 months, 9 months and 12 months (this includes specimen collections, interviews, and surveys). Participants will also be asked to wear a Fitbit for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | Participants will complete assessments at baseline, 3 months, 6 months, 9 months and 12 months. (this includes specimen collections, interviews, and surveys). Participants will also be asked to wear a Fitbit for 12 months. |
| Maya mobile app | Experimental | Maya mobile app- CBT based self-help app Receives: Behavioral: Maya App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety symptoms based on the General Anxiety Disorder-7 Scale (GAD-7) between the intervention arm and the no intervention arm
The GAD-7 is a 7 item questionnaire to measure the severity of anxiety symptoms (scores between 0-21). The items measure both psychic anxiety and somatic anxiety, where higher scores, defined by a score range of greater than or equal to 10, indicate a greater presence of symptoms and lower scores, defined by a score range of 0-9, indicate mild to no anxiety symptoms. Change in anxiety ratings between the intervention arm and the no intervention arm.
Measured: Baseline, up to 12 months
Change in depressive symptoms based on the Patient Health Questionnaire-9 (PHQ-9) between the intervention arm and the no intervention arm
The PHQ-9 is a 9-item scale containing three subscales measuring physical, cognitive, and social concerns regarding depression. Higher scores, defined by a score range of greater than or equal to 10, reflect greater presence of symptoms and lower scores, defined by a score range of 0-9, indicate mild to no depression symptoms. Change in depression ratings between the intervention arm and the no intervention arm.
Measured: Baseline, up to 12 months
Change in anxiety symptoms based on the Spielberger State and Trait Anxiety Inventory (STAI) between the intervention arm and the no intervention arm
The Spielberger State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety) and trait anxiety (anxiety related to personality). The scale consists of 20 questions to determine state and 20 questions for trait anxiety with a 4-point Likert scale, a higher score indicates greater anxiety. Total score for state and trait measures ranges from 20 (no anxiety) to 80 (maximum anxiety). Change in anxiety ratings between the intervention arm and the no intervention arm.
Measured: Baseline, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start23 Aug 2022
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants that have a Android will be assigned to the no intervention arm.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Pritzker Consortium, Weill Medical College of Cornell University, Hope for Depression Research Foundation
- Responsible party
- Principal investigator, Huda Akil, University of Michigan
- Investigators
- Huda Akil, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498207
- Sponsor's protocol ID
- HUM00211856
- Status last verified
- Jun 2026
- First submitted
- 9 Aug 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of the proposed study will be shared with the scientific community after deidentification. The analytic code the team used will also be shared. Sharing will require a proposal from scientists who specify the questions to be asked and describe methodologically sound approaches to address their aims. Proposals should be directed to akil@umich.edu. To get access to the data, requestors will need to sign a data transfer and use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers for Stress Vulnerability and Resilience
- ClinicalTrials.gov ID
- NCT05498207
- Acronym / sponsor ID
- HUM00211856
- Conditions
- Healthy
- Keywords
- Mental Health, Mobile application, Cognitive Behavioral Therapy (CBT), Stress, Fitbit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Pritzker Consortium, Weill Medical College of Cornell University, Hope for Depression Research Foundation
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Aug 2022 (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.
The purpose of this research study is to understand the biological mechanisms of stress vulnerability (being susceptible to stress) and stress resilience (being able to recover readily from stress), obtain biomarkers (a biological indicator) for stress resilience and to devise strategies for prevention and treatment of stress-related disorders.
Detailed description
This study will be using the Maya application (app) for the intervention arm, a mobile cognitive behavior therapy (CBT) program for adolescents and young adults experiencing anxiety symptoms. The Maya app, developed at Weill Cornell, teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants that have a Android will be assigned to the no intervention arm.
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –Participants will complete assessments at baseline, 3 months, 6 months, 9 months and 12 months. (this includes specimen collections, interviews, and surveys). Participants will also be asked to wear a Fitbit for 12 months. |
| Maya mobile app | Experimental | Behavioral: Maya AppMaya mobile app- CBT based self-help app |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Incoming Freshmen Students at the University of Michigan
Key exclusion criteria (1 listed)
- Suicidal Ideation
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 |
|---|---|---|
| Maya AppParticipants will utilize the Maya App for at least 20 minutes per day, 2 days per week, for 6 weeks. Additionally, participants will complete assessments at baseline, 3 months, 6 months, 9 months and 12 months (this includes specimen collections, interviews, and surveys). Participants will also be asked to wear a Fitbit for 12 months. | Behavioural | Maya mobile app |
Primary outcome
Change in anxiety symptoms based on the General Anxiety Disorder-7 Scale (GAD-7) between the intervention arm and the no intervention arm
Time frame: Baseline, up to 12 months
The GAD-7 is a 7 item questionnaire to measure the severity of anxiety symptoms (scores between 0-21). The items measure both psychic anxiety and somatic anxiety, where higher scores, defined by a score range of greater than or equal to 10, indicate a greater presence of symptoms and lower scores, defined by a score range of 0-9, indicate mild to no anxiety symptoms. Change in anxiety ratings between the intervention arm and the no intervention arm.
Change in depressive symptoms based on the Patient Health Questionnaire-9 (PHQ-9) between the intervention arm and the no intervention arm
Time frame: Baseline, up to 12 months
The PHQ-9 is a 9-item scale containing three subscales measuring physical, cognitive, and social concerns regarding depression. Higher scores, defined by a score range of greater than or equal to 10, reflect greater presence of symptoms and lower scores, defined by a score range of 0-9, indicate mild to no depression symptoms. Change in depression ratings between the intervention arm and the no intervention arm.
Change in anxiety symptoms based on the Spielberger State and Trait Anxiety Inventory (STAI) between the intervention arm and the no intervention arm
Time frame: Baseline, up to 12 months
The Spielberger State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety) and trait anxiety (anxiety related to personality). The scale consists of 20 questions to determine state and 20 questions for trait anxiety with a 4-point Likert scale, a higher score indicates greater anxiety. Total score for state and trait measures ranges from 20 (no anxiety) to 80 (maximum anxiety). Change in anxiety ratings between the intervention arm and the no intervention arm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of the proposed study will be shared with the scientific community after deidentification. The analytic code the team used will also be shared. Sharing will require a proposal from scientists who specify the questions to be asked and describe methodologically sound approaches to address their aims. Proposals should be directed to akil@umich.edu. To get access to the data, requestors will need to sign a data transfer and use agreement.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Huda Akil, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maya App in people with Healthy, run by University of Michigan 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginia Weinberg (734-936-4820, gweinber@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety symptoms based on the General Anxiety Disorder-7 Scale (GAD-7) between the intervention arm and the no intervention arm (time frame: Baseline, up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.