Identification of Biomarkers for Stress Vulnerability and Resilience
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-22
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Incoming Freshmen Students at the University of Michigan
Disqualifiers
Suicidal Ideation
Trial design
Design model
Parallel
Treatments tested in this trial
Maya App
BehavioralParticipants 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: No InterventionNo intervention 0 interventions
Group B: Maya mobile appExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, up to 12 months2
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.
Time frame
Baseline, up to 12 months3
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.
Time frame
Baseline, up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Pritzker Consortium
Collaborator
Weill Medical College of Cornell University
Collaborator
Hope for Depression Research Foundation
Collaborator
Source ClinicalTrials.gov