Mobile Cognitive Behavioral Therapy for Medical and Graduate Students

NCT ID: NCT05823922

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety Disorders Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Clinician-delivered Cognitive Behavioral Therapy only

Participants receive treatment with a licensed clinician for 6 weeks.

Group Type ACTIVE_COMPARATOR

Clinician Delivered CBT

Intervention Type 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

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

Group Type EXPERIMENTAL

Clinician Delivered CBT

Intervention Type 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.

Supplemental MAYA App

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Marino

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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22-08025115

Identifier Type: -

Identifier Source: org_study_id

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