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Mobile Cognitive Behavioral Therapy for Medical and Graduate Students

Primary Purpose

Anxiety Disorders, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinician Delivered CBT
Supplemental MAYA App
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Anxiety, Mobile Application, Cognitive Behavioral Therapy, Graduate Students

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Cornell Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clinician-delivered Cognitive Behavioral Therapy only

Clinician-delivered CBT + Supplemental app

Arm Description

Participants receive treatment with a licensed clinician for 6 weeks.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2023
Last Updated
September 29, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT05823922
Brief Title
Mobile Cognitive Behavioral Therapy for Medical and Graduate Students
Official Title
Feasibility and Efficacy of Mobile Cognitive Behavioral Therapy for Medical and Graduate Students
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression
Keywords
Anxiety, Mobile Application, Cognitive Behavioral Therapy, Graduate Students

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinician-delivered Cognitive Behavioral Therapy only
Arm Type
Active Comparator
Arm Description
Participants receive treatment with a licensed clinician for 6 weeks.
Arm Title
Clinician-delivered CBT + Supplemental app
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Clinician Delivered CBT
Intervention Description
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
Intervention Name(s)
Supplemental MAYA App
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in anxiety symptoms from baseline to end of treatment as measured by the GAD-7.
Description
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.
Time Frame
Baseline to endpoint [Week 6]
Title
Change in depressive symptoms from baseline to end of treatment as measured by the PHQ-9
Description
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.
Time Frame
Baseline to endpoint [Week 6]
Secondary Outcome Measure Information:
Title
Adherence as measured by the mean difference in total number of completed clinician assigned homework between groups
Time Frame
Endpoint [Week 6]
Title
Retention as measured by the mean difference in total number of completed study weeks between groups
Time Frame
Endpoint [Week 6]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Marino, Ph.D
Phone
914-997-8691
Email
pam2029@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Marino
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Marino, Ph.D
Phone
914-997-8691
Email
pam2029@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Patricia Marino, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mobile Cognitive Behavioral Therapy for Medical and Graduate Students

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