Identification of Biomarkers for Stress Vulnerability and Resilience

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Maya App

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginia Weinberg; Phone Number: 734-936-4820; Email: gweinber@umich.edu
• Study Contact Backup: Name: Cortney Turner, PhD; Phone Number: 734-936-2034; Email: caturner@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Virginia Weinberg; Phone Number: 734-936-4820; Email: gweinber@umich.edu
      • Principal Investigator: Huda Akil, PhD
      • Sub-Investigator: Juan Lopez, MD
      • Sub-Investigator: Cortney Turner, PhD
      • Sub-Investigator: Stanley Watson, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Incoming Freshmen Students at the University of Michigan

Exclusion Criteria:

• Suicidal Ideation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Weill Medical College of Cornell University; Pritzker Consortium
• Investigators: Principal Investigator: Huda Akil, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Mental Health; Stress; Fitbit; Mobile application; Cognitive Behavioral Therapy (CBT)
• Other Study ID Numbers: HUM00211856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be made available upon full publication of the results and will end 36 months following article publication.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No