Identification of Biomarkers for Stress Vulnerability and Resilience

NCT ID: NCT05498207

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2027-10-31

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants that have a Android will be assigned to the no intervention arm.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Maya mobile app

Maya mobile app- CBT based self-help app

Group Type EXPERIMENTAL

Maya App

Intervention Type BEHAVIORAL

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.

Interventions

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Maya App

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Incoming Freshmen Students at the University of Michigan

Exclusion Criteria

* Suicidal Ideation
Minimum Eligible Age

18 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pritzker Consortium

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

Hope for Depression Research Foundation

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Huda Akil

Professor of Neurosciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huda Akil, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Virginia Weinberg

Role: CONTACT

734-936-4820

Cortney Turner, PhD

Role: CONTACT

734-936-2034

Facility Contacts

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Virginia Weinberg

Role: primary

734-936-4820

Other Identifiers

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HUM00211856

Identifier Type: -

Identifier Source: org_study_id

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