Identification of Biomarkers for Stress Vulnerability and Resilience
1 other identifier
interventional
500
1 country
1
Brief 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 of stress-related disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Aug 2022
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedStudy Start
First participant enrolled
August 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
July 1, 2025
June 1, 2025
5.1 years
August 9, 2022
June 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Baseline, up to 12 months
Study Arms (2)
No Intervention
NO INTERVENTIONParticipants 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
EXPERIMENTALMaya mobile app- CBT based self-help app
Interventions
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.
Eligibility Criteria
You may qualify if:
- Incoming Freshmen Students at the University of Michigan
You may not qualify if:
- Suicidal Ideation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Pritzker Consortiumcollaborator
- Weill Medical College of Cornell Universitycollaborator
- Hope for Depression Research Foundationcollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huda Akil, PhD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurosciences
Study Record Dates
First Submitted
August 9, 2022
First Posted
August 11, 2022
Study Start
August 23, 2022
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- Data will be made available upon full publication of the results and will end 36 months following article publication.
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.