Mobile Cognitive Behavioral Therapy for Medical and Graduate Students

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823922
• Other study ID #: 22-08025115
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Weill Medical College of Cornell University
• Contact: Patricia Marino, Ph.D
• Phone: 914-997-8691
• Email: pam2029[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	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	Adherence as measured by the mean difference in total number of completed clinician assigned homework between groups		Endpoint [Week 6]
Secondary	Retention as measured by the mean difference in total number of completed study weeks between groups		Endpoint [Week 6]