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Mobile Cognitive Behavioral Therapy for Anxiety and Depression
N/A
Recruiting
Led By Patricia Marino
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up endpoint [week 6]
Awards & highlights
Study Summary
This trial aims to compare how effective CBT with a mobile app is compared to CBT alone for improving anxiety and depression.
Who is the study for?
This trial is for medical and graduate students aged 18-40 at Weill Cornell Medicine who are experiencing significant anxiety or depression, as indicated by specific scores on recognized scales. It's not open to those with a history of bipolar or psychotic disorders, or current severe suicidal intentions.Check my eligibility
What is being tested?
The study compares two approaches: standard clinician-delivered cognitive behavioral therapy (CBT) versus CBT with the addition of 'MAYA', a mobile app designed to support mental health. Participants will use MAYA twice weekly alongside regular CBT sessions and complete weekly self-assessments.See study design
What are the potential side effects?
While using the MAYA app isn't expected to have physical side effects, participants may experience emotional discomfort when confronting difficult thoughts or feelings during cognitive behavioral therapy exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ endpoint [week 6]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~endpoint [week 6]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in anxiety symptoms from baseline to end of treatment as measured by the GAD-7.
Change in depressive symptoms from baseline to end of treatment as measured by the PHQ-9
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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Clinician-delivered CBT + Supplemental appExperimental Treatment2 Interventions
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 II: Clinician-delivered Cognitive Behavioral Therapy onlyActive Control1 Intervention
Participants receive treatment with a licensed clinician for 6 weeks.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,316,043 Total Patients Enrolled
16 Trials studying Anxiety Disorders
881 Patients Enrolled for Anxiety Disorders
Patricia MarinoPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have access to an Apple iPhone.I am between 18 and 40 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Clinician-delivered CBT + Supplemental app
- Group 2: Clinician-delivered Cognitive Behavioral Therapy only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anxiety Disorders Patient Testimony for trial: Trial Name: NCT05823922 — N/A
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