Identification of Biomarkers for Stress Vulnerability and Resilience

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Behavioral: Maya App

• Registration Number: NCT05498207
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-08-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Incoming Freshmen Students at the University of Michigan

Exclusion Criteria

• Suicidal Ideation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maya mobile app	Maya App	Maya mobile app- CBT based self-help app

Primary Outcome Measures

Name	Time	Method
Change in anxiety symptoms based on the Spielberger State and Trait Anxiety Inventory (STAI) between the intervention arm and the no intervention arm	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.
Change in anxiety symptoms based on the General Anxiety Disorder-7 Scale (GAD-7) between the intervention arm and the no intervention arm	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	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States