Clinical trial NCT05823922: 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
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety Disorders
Depression
Keywords: Anxiety
Mobile Application
Cognitive Behavioral Therapy
Graduate Students
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in anxiety symptoms from baseline to end of treatment as measured by the GAD-7.
timeFrame: Baseline to endpoint [Week 6]
measure: Change in depressive symptoms from baseline to end of treatment as measured by the PHQ-9
timeFrame: Baseline to endpoint [Week 6]
Secondary outcomes:
measure: Adherence as measured by the mean difference in total number of completed clinician assigned homework between groups
timeFrame: Endpoint [Week 6]
measure: Retention as measured by the mean difference in total number of completed study weeks between groups
timeFrame: Endpoint [Week 6]
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Patricia Marino
role: PRINCIPAL_INVESTIGATOR
References: