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Mobile Cognitive Behavioral Therapy for Medical and Graduate Students

Not Applicable
Recruiting
Conditions
Anxiety Disorders
Depression
Interventions
Behavioral: Clinician Delivered CBT
Behavioral: Supplemental MAYA App
Registration Number
NCT05823922
Lead Sponsor
Weill Medical College of Cornell University
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
100
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
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Exclusion Criteria
  • Lifetime diagnosis of a bipolar or psychotic disorder.
  • Intent or plan to attempt suicide.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Clinician-delivered Cognitive Behavioral Therapy onlyClinician Delivered CBTParticipants receive treatment with a licensed clinician for 6 weeks.
Clinician-delivered CBT + Supplemental appClinician Delivered CBTMobile 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
Clinician-delivered CBT + Supplemental appSupplemental MAYA AppMobile 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
Primary Outcome Measures
NameTimeMethod
Change in depressive symptoms from baseline to end of treatment as measured by the PHQ-9Baseline to endpoint [Week 6]

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.

Change in anxiety symptoms from baseline to end of treatment as measured by the GAD-7.Baseline to endpoint [Week 6]

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.

Secondary Outcome Measures
NameTimeMethod
Adherence as measured by the mean difference in total number of completed clinician assigned homework between groupsEndpoint [Week 6]
Retention as measured by the mean difference in total number of completed study weeks between groupsEndpoint [Week 6]

Trial Locations

Locations (1)

Weill Cornell Medical College

🇺🇸

New York, New York, United States

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