Mobile Cognitive Behavioral Therapy for Medical and Graduate Students

Feasibility and Efficacy of Mobile Cognitive Behavioral Therapy for Medical and Graduate Students

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety Disorders
• Intervention / Treatment: Behavioral: Clinician Delivered CBT; Behavioral: Supplemental MAYA App

Detailed Description

Growing evidence suggests a need for anxiety and depression treatments that can be disseminated easily to young adults. Many do not seek out treatment for reasons including lack of availability and high cost. There is a growing need for accessible, affordable, research-supported treatments designed to increase the practice of skills and therefore improve treatment outcomes. Graduate students use mobile devices frequently; thus, mobile app-based interventions may be particularly appealing to individuals in this age range with anxiety or depression who are unable to access more traditional psychotherapy administered in person by a therapist.

The study aims to compare the efficacy and feasibility of clinician-delivered cognitive behavior therapy supplemented with the mobile app program to clinician- delivered cognitive behavioral therapy alone. Young adults with anxiety and/or depression will be randomized to clinician-delivered CBT (active control group) or to the clinician CBT + mobile app (intervention group). In the active control group, participants will participate in weekly clinician-delivered Cognitive Behavior Therapy. In the intervention group, participants will participate in weekly clinician-delivered Cognitive Behavior Therapy and use a mobile application for at least 20 minutes two times per week for six weeks.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Marino, Ph.D; Phone Number: 914-997-8691; Email: pam2029@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medical College
      • Contact: Patricia Marino, Ph.D; Phone Number: 914-997-8691; Email: pam2029@med.cornell.edu
      • Principal Investigator: Patricia Marino, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinician-delivered Cognitive Behavioral Therapy only; Participants receive treatment with a licensed clinician for 6 weeks.	Behavioral: Clinician Delivered CBT; 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.
Experimental: Clinician-delivered CBT + Supplemental app; 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; 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.; Behavioral: Supplemental MAYA App; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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]

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Patricia Marino, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Cognitive Behavioral Therapy; Mobile Application; Graduate Students
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 22-08025115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No