Mobile Cognitive Behavioral Therapy for Medical and Graduate Students

NCT05823922 | Terminated

• 1 other identifier: 22-08025115
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess and compare clinician-delivered cognitive behavior therapy (CBT) supplemented with "MAYA", a mobile cognitive behavioral therapy app program to clinician-delivered cognitive behavioral therapy alone. The experimental group will be asked to use the mobile application at least two times per week for six weeks, for at least 20 minutes on each of the two days in addition to the clinician-delivered CBT. Participants will complete a weekly self-report assessment battery designed to assess anxiety and mood symptoms. The investigators think that clinician-delivered CBT supplemented with "MAYA" will improve more effective at improving symptoms of anxiety and depression than clinician-delivered CBT alone.

Conditions

Anxiety Disorders; Depression

Keywords

Anxiety; Mobile Application; Cognitive Behavioral Therapy; Graduate Students

Outcome Measures

Primary Outcomes (2)

• Change in anxiety symptoms from baseline to end of treatment as measured by the GAD-7.

  The primary symptom measure for anxiety will be the Generalized Anxiety Disorder 7-item scale. The GAD-7 is a 7-item self-report questionnaire measure of the severity of generalized anxiety symptoms. Scores range from 0 to 27 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 baseline to end of treatment as measured by the PHQ-9

  The primary symptom measure for depression will be the Patient Health Questionnaire 9-item measure (PHQ-9). The PHQ-9 is a 9-item self-report questionnaire measure of the severity of depression symptoms. Scores range from 0 to 27, where higher scores indicate a greater severity of symptoms, and lower scores indicate mild to no depression symptoms.

  Baseline to endpoint [Week 6]

Secondary Outcomes (2)

• Adherence as measured by the mean difference in total number of completed clinician assigned homework between groups

  Endpoint [Week 6]

• Retention as measured by the mean difference in total number of completed study weeks between groups

  Endpoint [Week 6]

Study Arms (2)

Clinician-delivered Cognitive Behavioral Therapy only

ACTIVE COMPARATOR

Participants receive treatment with a licensed clinician for 6 weeks.

Behavioral: Clinician Delivered CBT

Clinician-delivered CBT + Supplemental app

EXPERIMENTAL

Mobile application at least two times per week for six weeks, for at least 20 minutes on each of the two days in addition to the clinician-delivered CBT

Behavioral: Clinician Delivered CBT; Behavioral: Supplemental MAYA App

Interventions

Clinician Delivered CBT BEHAVIORAL

Clinicians teach cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety and depression. Participants will attend weekly sessions with their clinician for 6 weeks.

Clinician-delivered CBT + Supplemental app; Clinician-delivered Cognitive Behavioral Therapy only

Supplemental MAYA App BEHAVIORAL

The Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety. Participants will attend weekly sessions with their clinician as well as using the MAYA application for at least 20 minutes twice a week

Clinician-delivered CBT + Supplemental app

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 40 years.
• Clinically significant anxiety (as determined by a score of 10 or greater on the GAD-7) or clinically significant depression (as determined by a score of 10 or greater on the PHQ-9).
• Current graduate student at Weill Cornell Medicine.
• Access to an Apple iPhone

You may not qualify if:

• Lifetime diagnosis of a bipolar or psychotic disorder.
• Intent or plan to attempt suicide.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Patricia Marino

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a randomized clinical trial designed to compare the efficacy of clinician-delivered cognitive behavior therapy supplemented with a mobile cognitive behavioral therapy program in improving anxiety and depression in graduate students. Participants will be randomized to one of two conditions: 1) Clinician-delivered Cognitive Behavior Therapy 2) Clinician-delivered Cognitive Behavior Therapy and CBT mobile app

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: November 17, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)