Personalized Mobile Cognitive Behavioral Therapy Application

NCT05699525 | Recruiting DMC

• 1 other identifier: 21-09023953
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (4)

• Change in anxiety symptoms from pre-intervention to post-intervention as measured by the HAM-A.

  The primary symptom measure for anxiety will be the Hamilton Rating Scale for Anxiety (HAM-A). The HAM-A is a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety. The scores range from 0 to 56, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.

  Baseline to endpoint [Week 6]

• Change in depressive symptoms from pre-intervention to post-intervention as measured by HAM-D.

  The primary symptom measure for depression will be the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 24-item questionnaire measuring the severity of depression symptoms. The scale ranges from 0 to 76, where higher scores indicate higher severity of depressive symptoms.

  Baseline to endpoint [Week 6]

• Change in anxiety symptoms from pre-intervention to post-intervention as measured by the anxiety subscale of the DASS.

  Anxiety will be measured by the anxiety subscale of the Depression Anxiety Stress Scale (DASS). The anxiety subscale measures of the severity of anxiety symptoms. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.

  Baseline to endpoint [Week 6]

• Change in depressive symptoms from pre-intervention to post-intervention as measured by the depression subscale of the DASS.

  Depression will be measured by the depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale measures of the severity of depressive symptoms. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no symptoms.

  Baseline to endpoint [Week 6]

Secondary Outcomes (10)

• Change in anxiety measure scores pre-intervention to post-active learning phase as measured by HAM-A

  Baseline to end of active learning phase [week 4]

• Change in anxiety measure scores pre-intervention to post-active learning phase as measured by the anxiety subscale of the DASS.

  Baseline to end of active learning phase [week 4]

• Change in depression measure scores pre-intervention to post-active learning phase as measured by HAM-D.

  Baseline to end of active learning phase [week 4]

• Change in depression measure scores pre-intervention to post-active learning phase as measured by the depression subscale of the DASS.

  Baseline to end of active learning phase [week 4]

• Change in social anxiety from pre-intervention to post-intervention as measured by LSAS.

  Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]

Study Arms (2)

Personalized

EXPERIMENTAL

Participants receive the personalized Maya app intervention for 6 weeks

Behavioral: Personalized MAYA Mobile App

General Non-Personalized

ACTIVE COMPARATOR

Participants receive the general MAYA app intervention for 6 weeks

Behavioral: General MAYA Mobile App

Interventions

Personalized MAYA Mobile App 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.

Personalized

General MAYA Mobile App BEHAVIORAL

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

General Non-Personalized

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Children's Health Fund: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Bipolar Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Jennifer Bress, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maddy Schier

CONTACT

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

Zareen Mir

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: August 2, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)