Anxiety DisordersNCT05823922
Mobile Cognitive Behavioral Therapy for Medical and Graduate Students
A study testing Clinician Delivered CBT and Supplemental MAYA App in people with Anxiety Disorders and Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- Clinician Delivered CBT and Supplemental MAYA App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Lifetime diagnosis of a bipolar or psychotic disorder.
- Intent or plan to attempt suicide.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Feasibility and Efficacy of Mobile Cognitive Behavioral Therapy for Medical and Graduate Students
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.
Read the 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.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- Clinician Delivered CBT, Supplemental MAYA App
- Keywords
- Anxiety, Mobile Application, Cognitive Behavioral Therapy, Graduate Students
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician Delivered CBTBehavioural
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 AppBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Clinician-delivered Cognitive Behavioral Therapy only | Active comparator | Participants receive treatment with a licensed clinician for 6 weeks. Receives: Behavioral: Clinician Delivered CBT |
| Clinician-delivered CBT + Supplemental app | Experimental | 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 Receives: Behavioral: Clinician Delivered CBT; Behavioral: Supplemental MAYA App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to endpoint [Week 6]
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.
Measured: Baseline to endpoint [Week 6]
Secondary outcomes (2)
Adherence as measured by the mean difference in total number of completed clinician assigned homework between groups
Measured: Endpoint [Week 6]
Retention as measured by the mean difference in total number of completed study weeks between groups
Measured: Endpoint [Week 6]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start17 Nov 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Marino, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823922
- Sponsor's protocol ID
- 22-08025115
- Status last verified
- Feb 2025
- First submitted
- 10 Apr 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Mobile Cognitive Behavioral Therapy for Medical and Graduate Students
- ClinicalTrials.gov ID
- NCT05823922
- Acronym / sponsor ID
- 22-08025115
- Conditions
- Anxiety Disorders, Depression
- Keywords
- Anxiety, Mobile Application, Cognitive Behavioral Therapy, Graduate Students
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Clinician-delivered Cognitive Behavioral Therapy only | Active comparator | Behavioral: Clinician Delivered CBTParticipants receive treatment with a licensed clinician for 6 weeks. |
| Clinician-delivered CBT + Supplemental app | Experimental | Behavioral: Clinician Delivered CBT, Behavioral: Supplemental 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Lifetime diagnosis of a bipolar or psychotic disorder.
- Intent or plan to attempt suicide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician Delivered CBTClinicians 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. | Behavioural | Clinician-delivered CBT + Supplemental app, Clinician-delivered Cognitive Behavioral Therapy only |
| Supplemental MAYA AppThe 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 | Behavioural | Clinician-delivered CBT + Supplemental app |
Primary outcome
Change in anxiety symptoms from baseline to end of treatment as measured by the GAD-7.
Time frame: 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.
Change in depressive symptoms from baseline to end of treatment as measured by the PHQ-9
Time frame: Baseline 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.
2 secondary outcomes
Adherence as measured by the mean difference in total number of completed clinician assigned homework between groups
Time frame: Endpoint [Week 6]
Retention as measured by the mean difference in total number of completed study weeks between groups
Time frame: Endpoint [Week 6]
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Marino principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician Delivered CBT and Supplemental MAYA App in people with Anxiety Disorders and Depression, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety symptoms from baseline to end of treatment as measured by the GAD-7. (time frame: Baseline to endpoint [Week 6]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.