Recruiting

Mobile CBT

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05699525

Conditions

Anxiety Disorders and Symptoms

Depression

Bipolar Disorder

Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

Personalized MAYA Mobile App

General MAYA Mobile App

Study Details

Brief summary:

This study aims to compare the effectiveness of a standard mobile cognitive behavioral therapy program to a personalized mobile cognitive behavioral therapy program that introduces new skills over a shorter period of time. Participants will use the Maya app for two days per week, at least 20 minutes per day, for six weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and optional electroencephalographic (EEG) recordings at the beginning and end of the 6-week intervention. The investigators think that that the less burdensome personalized program will be just as effective at improving symptoms of anxiety and depression as the general program.

Conditions

Anxiety Disorders and Symptoms

Depression

Bipolar Disorder

Symptoms

Study ID

NCT05699525

Start date

Aug 2, 2024

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age between 18 and 25 years.
  • Primary diagnosis of an anxiety, depressive, or bipolar disorder as determined by a score of 4 or greater on the Clinical Severity Rating of the Anxiety Disorders Interview Schedule (ADIS).
  • If an individual is diagnosed with bipolar disorder, they must be currently euthymic or experiencing a depressive episode.
  • Access to an Apple iPhone, iPad, or Android device.

Exclusion Criteria:

  • History of neurologic disorder that may affect the neural systems of interest or participant's ability to participate
  • Lifetime diagnosis of a psychotic disorder.
  • Current hypomanic or manic episode.
  • Currently in cognitive behavior therapy.
  • Change in dose of a psychiatric medication in the past 12 weeks.
  • Initiation of psychotherapy in the past 12 weeks.
  • Intent or plan to attempt suicide.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Personalized

Participants receive the personalized Maya app intervention for 6 weeks

active comparator: General Non-Personalized

Participants receive the general MAYA app intervention for 6 weeks

Interventions

Personalized MAYA Mobile App

All new material in the personalized condition will be introduced within the first four weeks and will contain modules targeting participant's personal symptom profiles. The remaining two weeks in the personalized condition will consist of practicing previously learned skills.

General MAYA Mobile App

New material will be introduced to participants over all the six weeks of the intervention and will include all application modules.

Primary outcome measure

  • Change in anxiety symptoms from pre-intervention to post-intervention as measured by the HAM-A. [ Time Frame: Baseline to endpoint [Week 6] ]
  • Change in depressive symptoms from pre-intervention to post-intervention as measured by HAM-D. [ Time Frame: Baseline to endpoint [Week 6] ]
  • Change in anxiety symptoms from pre-intervention to post-intervention as measured by the anxiety subscale of the DASS. [ Time Frame: Baseline to endpoint [Week 6] ]
  • Change in depressive symptoms from pre-intervention to post-intervention as measured by the depression subscale of the DASS. [ Time Frame: Baseline to endpoint [Week 6] ]

Central Contacts and Locations

Central contacts

Maddy Schier

(646) 289-5271mas4019@med.cornell.edu

Zareen Mir

(646)-289-5271zam4005@med.cornell.edu

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Jennifer Bress, Ph.D

914.997.8683jeb2061@med.cornell.edu

Maddy Schier

(646) 289-5271mas4019@med.cornell.edu

Principal Investigator:

Jennifer Bress, Ph.D

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-05-22.