Personalized Mobile Cognitive Behavioral Therapy Application

NCT ID: NCT05699525

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-02
• Study Completion Date: 2027-07-31

Brief Summary

This study aims to compare the effectiveness of a standard mobile iPhone cognitive behavioral therapy program to a personalized mobile iPhone 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 magnetic resonance imaging (MRI) and 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.

Detailed Description

Growing evidence suggests a need for anxiety and mood interventions that can be disseminated easily to adolescents and young adults. The goal of this study is to optimize a mobile application that teaches well-established, research-supported psychotherapeutic techniques to adolescents and young adults who are experiencing symptoms of anxiety, depression, and/or bipolar disorder. The study aims to compare the efficacy of a personalized mobile cognitive behavioral therapy program to a more general mobile cognitive behavioral therapy program.

Study participants will randomly receive one of two versions of Maya, a mobile cognitive behavior therapy (CBT) app for adolescents and young adults: either a standard version that includes a variety of skills typically used in CBT, or a personalized version with skills matched to the participant's symptom profile. In contrast to the general condition, which may introduce new material over all six weeks of the intervention, all new material in the personalized condition will be introduced within the first four weeks. The remaining two weeks in the personalized condition will consist of practicing previously learned skills. Participants will use the Maya app for two days per week, at least 20 minutes per day for six weeks and will complete assessments at baseline, week 4, week 6 (end of intervention), and a follow-up assessment at week 12. Participants may also choose to complete an optional magnetic resonance imaging (MRI) and/or electroencephalographic (EEG) recording at the baseline and end of intervention (week 6).

Conditions

Anxiety Disorders and Symptoms; Depression; Bipolar Disorder; Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Personalized

Participants receive the personalized Maya app intervention for 6 weeks

Group Type: EXPERIMENTAL

Personalized MAYA Mobile App

Intervention Type: BEHAVIORAL

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 Non-Personalized

Participants receive the general MAYA app intervention for 6 weeks

Group Type: ACTIVE_COMPARATOR

General MAYA Mobile App

Intervention Type: BEHAVIORAL

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

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Health Fund

UNKNOWN

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Bress, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maddy Schier

Role: CONTACT

mas4019@med.cornell.edu

(646) 289-5271 ext. 720

Zareen Mir

Role: CONTACT

zam4005@med.cornell.edu

(646)-289-5271 ext. 705

Facility Contacts

Jennifer Bress, Ph.D

Role: primary

jeb2061@med.cornell.edu

914-997-8683

Maddy Schier

Role: backup

mas4019@med.cornell.edu

(646) 289-5271 ext. 720

Other Identifiers

21-09023953

Identifier Type: -

Identifier Source: org_study_id