Recruiting

Stress Resilience

Sponsor:

University of Michigan

Code:

NCT05498207

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 22

Healthy Volunteers: Accepted

Interventions

Maya App

Study Details

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.

Conditions

Healthy

Study ID

NCT05498207

Start date

Aug 23, 2022

Status verified date

Jun, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 22

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Incoming Freshmen Students at the University of Michigan

Exclusion Criteria:

  • Suicidal Ideation

Study Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Maya mobile app

Maya mobile app- CBT based self-help app

Interventions

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.

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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Huda Akil, PhD

More Information

Sponsor

University of Michigan

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Mental Health
  • Mobile application
  • Cognitive Behavioral Therapy (CBT)
  • Stress
  • Fitbit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-23.