Anxiety Disorders and SymptomsNCT05699525
Personalized Mobile Cognitive Behavioral Therapy Application
A study testing Personalized MAYA Mobile App and General MAYA Mobile App in people with Anxiety Disorders and Symptoms and Depression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study aims to compare the effectiveness of a standard mobile cognitive behavioral therapy program to a personalized mobile cognitive behavioral therapy program that introduces new skills over a shorter period of time. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Anxiety Disorders and Symptoms, Depression, Bipolar Disorder
- What is being tested?
- Personalized MAYA Mobile App and General MAYA Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 25 years.
- Primary diagnosis of an anxiety, depressive, or bipolar disorder as determined by a score of 4 or greater on the Clinical Severity Rating of the Anxiety Disorders Interview Schedule (ADIS).
- If an individual is diagnosed with bipolar disorder, they must be currently euthymic or experiencing a depressive episode.
- Access to an Apple iPhone, iPad, or Android device.
Who cannot join
- History of neurologic disorder that may affect the neural systems of interest or participant's ability to participate
- Lifetime diagnosis of a psychotic disorder.
- Current hypomanic or manic episode.
- Currently in cognitive behavior therapy.
- Change in dose of a psychiatric medication in the past 12 weeks.
- Initiation of psychotherapy in the past 12 weeks.
- Intent or plan to attempt suicide.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
Jennifer Bress, Ph.D, 914.997.8683, jeb2061@med.cornell.edu
Maddy Schier, (646) 289-5271 ext. 720, mas4019@med.cornell.edu
About this study
Official title: Efficacy of Personalized Mobile Cognitive Behavioral Therapy Targeting Anxiety and Depression
This study aims to compare the effectiveness of a standard mobile cognitive behavioral therapy program to a personalized mobile cognitive behavioral therapy program that introduces new skills over a shorter period of time. Participants will use the Maya app for two days per week, at least 20 minutes per day, for six weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and optional electroencephalographic (EEG) recordings at the beginning and end of the 6-week intervention. The investigators think that that the less burdensome personalized program will be just as effective at improving symptoms of anxiety and depression as the general program.
Read the detailed description
Growing evidence suggests a need for anxiety and mood interventions that can be disseminated easily to adolescents and young adults. The goal of this study is to optimize a mobile application that teaches well-established, research-supported psychotherapeutic techniques to adolescents and young adults who are experiencing symptoms of anxiety, depression, and/or bipolar disorder. The study aims to compare the efficacy of a personalized mobile cognitive behavioral therapy program to a more general mobile cognitive behavioral therapy program.
Study participants will randomly receive one of two versions of Maya, a mobile cognitive behavior therapy (CBT) app for adolescents and young adults: either a standard version that includes a variety of skills typically used in CBT, or a personalized version with skills matched to the participant's symptom profile. In contrast to the general condition, which may introduce new material over all six weeks of the intervention, all new material in the personalized condition will be introduced within the first four weeks. The remaining two weeks in the personalized condition will consist of practicing previously learned skills. Participants will use the Maya app for two days per week, at least 20 minutes per day for six weeks and will complete assessments at baseline, week 4, week 6 (end of intervention), and a follow-up assessment at week 12. Participants may also choose to complete an optional electroencephalographic (EEG) recordings at the baseline and end of intervention (week 6).
- Conditions
- Anxiety Disorders and Symptoms, Depression, Bipolar Disorder, Symptoms
- Being tested
- Personalized MAYA Mobile App, General MAYA Mobile App
- Medical subject headings
- Anxiety Disorders, Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized MAYA Mobile AppBehavioural
All new material in the personalized condition will be introduced within the first four weeks and will contain modules targeting participant's personal symptom profiles. The remaining two weeks in the personalized condition will consist of practicing previously learned skills.
General MAYA Mobile AppBehavioural
New material will be introduced to participants over all the six weeks of the intervention and will include all application modules.
| Study group | Role | What they receive |
|---|---|---|
| Personalized | Experimental | Participants receive the personalized Maya app intervention for 6 weeks Receives: Behavioral: Personalized MAYA Mobile App |
| General Non-Personalized | Active comparator | Participants receive the general MAYA app intervention for 6 weeks Receives: Behavioral: General MAYA Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety symptoms from pre-intervention to post-intervention as measured by the HAM-A.
The primary symptom measure for anxiety will be the Hamilton Rating Scale for Anxiety (HAM-A). The HAM-A is a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety. The scores range from 0 to 56, 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 pre-intervention to post-intervention as measured by HAM-D.
The primary symptom measure for depression will be the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 24-item questionnaire measuring the severity of depression symptoms. The scale ranges from 0 to 76, where higher scores indicate higher severity of depressive symptoms.
Measured: Baseline to endpoint [Week 6]
Change in anxiety symptoms from pre-intervention to post-intervention as measured by the anxiety subscale of the DASS.
Anxiety will be measured by the anxiety subscale of the Depression Anxiety Stress Scale (DASS). The anxiety subscale measures of the severity of anxiety symptoms. The scores range from 0 to 42, 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 pre-intervention to post-intervention as measured by the depression subscale of the DASS.
Depression will be measured by the depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale measures of the severity of depressive symptoms. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no symptoms.
Measured: Baseline to endpoint [Week 6]
Secondary outcomes (10)
Change in anxiety measure scores pre-intervention to post-active learning phase as measured by HAM-A
Anxiety will be measured using the Hamilton Rating Scale for Anxiety (HAM-A). The HAM-A is a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety. The scores range from 0 to 56, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
Measured: Baseline to end of active learning phase [week 4]
Change in anxiety measure scores pre-intervention to post-active learning phase as measured by the anxiety subscale of the DASS.
Anxiety will be measured by the anxiety subscale of the Depression Anxiety Stress Scale (DASS). The anxiety subscale measures of the severity of anxiety symptoms. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
Measured: Baseline to end of active learning phase [week 4]
Change in depression measure scores pre-intervention to post-active learning phase as measured by HAM-D.
Depression will be scored using the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 24-item questionnaire measuring the severity of depression symptoms. The scale ranges from 0 to 76, where higher scores indicate higher severity of depressive symptoms.
Measured: Baseline to end of active learning phase [week 4]
Change in depression measure scores pre-intervention to post-active learning phase as measured by the depression subscale of the DASS.
Depression will be measured by the depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale measures of the severity of depressive symptoms. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no symptoms.
Measured: Baseline to end of active learning phase [week 4]
Change in social anxiety from pre-intervention to post-intervention as measured by LSAS.
Social anxiety will be measured using the Liebowitz Social Anxiety Scale (LSAS). The items measure social anxiety and extent of avoidance. Scores range from 0 to 144 where higher scores indicate higher levels of social anxiety.
Measured: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Change in anxiety sensitivity from pre-intervention to post-intervention as measured by ASI.
Anxiety sensitivity will be measured using the Anxiety Sensitivity Index (ASI). The items measure distress intolerance and fear of anxiety related sensations. Scores range from 0 to 72 where higher scores indicate higher levels of anxiety sensitivity.
Measured: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Change in avoidance from pre-intervention to post-intervention as measured by MEAQ.
Experiential avoidance will be measured using the Multidimensional Experiential Avoidance Questionnaire (MEAQ). The 62-item scale measures avoidance of negative internal experiences. Scores range from 62 to 372 where higher scores indicate higher levels of anxiety sensitivity.
Measured: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Change in anhedonia from pre-intervention to post-intervention as measured by TEPS.
Anhedonia will be measured using the Temporal Experience of Pleasure Scale (TEPS). The items measure anticipatory and consummatory experiences of pleasure. Scores range from 18 to 108 where higher scores indicate stronger feelings of anticipating and experiencing pleasure.
Measured: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Change in Negative affect from pre-intervention to post-intervention as measured by PANAS
Negative affect will be measured using the negative affect subscale of the Positive and Negative Affect Schedule (PANAS). Scores on the 10-item subscale range from 10 to 50, where higher scores indicate higher levels of negative affect.
Measured: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Bipolar symptoms from pre-intervention to post-intervention as measured by ISS.
Bipolar symptoms will be measured using the Internal State Scale (ISS). The ISS is a 15 item self-report instrument using a visual analog line scale format (i.e. participant chooses from 0-100 on the scale to respond to each item). The scale contains four subscales (Activation, Well Being, Depression Index, and Perceived Conflict). Scores range from 0 to 1500 where higher scores represent higher severity of symptoms for each subscale.
Measured: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start2 Aug 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorders and SymptomsStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Health Fund
- Responsible party
- Sponsor
- Investigators
- Jennifer Bress, Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699525
- Sponsor's protocol ID
- 21-09023953
- Status last verified
- May 2026
- First submitted
- 17 Jan 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Personalized Mobile Cognitive Behavioral Therapy Targeting Anxiety and Depression
- ClinicalTrials.gov ID
- NCT05699525
- Acronym / sponsor ID
- 21-09023953
- Conditions
- Anxiety Disorders and Symptoms, Depression, Bipolar Disorder, Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Children's Health Fund
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Jan 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.
This study aims to compare the effectiveness of a standard mobile cognitive behavioral therapy program to a personalized mobile cognitive behavioral therapy program that introduces new skills over a shorter period of time. Participants will use the Maya app for two days per week, at least 20 minutes per day, for six weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and optional electroencephalographic (EEG) recordings at the beginning and end of the 6-week intervention. The investigators think that that the less burdensome personalized program will be just as effective at improving symptoms of anxiety and depression as the general program.
Detailed description
Growing evidence suggests a need for anxiety and mood interventions that can be disseminated easily to adolescents and young adults. The goal of this study is to optimize a mobile application that teaches well-established, research-supported psychotherapeutic techniques to adolescents and young adults who are experiencing symptoms of anxiety, depression, and/or bipolar disorder. The study aims to compare the efficacy of a personalized mobile cognitive behavioral therapy program to a more general mobile cognitive behavioral therapy program.
Study participants will randomly receive one of two versions of Maya, a mobile cognitive behavior therapy (CBT) app for adolescents and young adults: either a standard version that includes a variety of skills typically used in CBT, or a personalized version with skills matched to the participant's symptom profile. In contrast to the general condition, which may introduce new material over all six weeks of the intervention, all new material in the personalized condition will be introduced within the first four weeks. The remaining two weeks in the personalized condition will consist of practicing previously learned skills. Participants will use the Maya app for two days per week, at least 20 minutes per day for six weeks and will complete assessments at baseline, week 4, week 6 (end of intervention), and a follow-up assessment at week 12. Participants may also choose to complete an optional electroencephalographic (EEG) recordings at the baseline and end of intervention (week 6).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized | Experimental | Behavioral: Personalized MAYA Mobile AppParticipants receive the personalized Maya app intervention for 6 weeks |
| General Non-Personalized | Active comparator | Behavioral: General MAYA Mobile AppParticipants receive the general MAYA app intervention for 6 weeks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 25 years.
- Primary diagnosis of an anxiety, depressive, or bipolar disorder as determined by a score of 4 or greater on the Clinical Severity Rating of the Anxiety Disorders Interview Schedule (ADIS).
- If an individual is diagnosed with bipolar disorder, they must be currently euthymic or experiencing a depressive episode.
- Access to an Apple iPhone, iPad, or Android device.
Key exclusion criteria (7 listed)
- History of neurologic disorder that may affect the neural systems of interest or participant's ability to participate
- Lifetime diagnosis of a psychotic disorder.
- Current hypomanic or manic episode.
- Currently in cognitive behavior therapy.
- Change in dose of a psychiatric medication in the past 12 weeks.
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 |
|---|---|---|
| Personalized MAYA Mobile AppAll new material in the personalized condition will be introduced within the first four weeks and will contain modules targeting participant's personal symptom profiles. The remaining two weeks in the personalized condition will consist of practicing previously learned skills. | Behavioural | Personalized |
| General MAYA Mobile AppNew material will be introduced to participants over all the six weeks of the intervention and will include all application modules. | Behavioural | General Non-Personalized |
Primary outcome
Change in anxiety symptoms from pre-intervention to post-intervention as measured by the HAM-A.
Time frame: Baseline to endpoint [Week 6]
The primary symptom measure for anxiety will be the Hamilton Rating Scale for Anxiety (HAM-A). The HAM-A is a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety. The scores range from 0 to 56, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
Change in depressive symptoms from pre-intervention to post-intervention as measured by HAM-D.
Time frame: Baseline to endpoint [Week 6]
The primary symptom measure for depression will be the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 24-item questionnaire measuring the severity of depression symptoms. The scale ranges from 0 to 76, where higher scores indicate higher severity of depressive symptoms.
Change in anxiety symptoms from pre-intervention to post-intervention as measured by the anxiety subscale of the DASS.
Time frame: Baseline to endpoint [Week 6]
Anxiety will be measured by the anxiety subscale of the Depression Anxiety Stress Scale (DASS). The anxiety subscale measures of the severity of anxiety symptoms. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
Change in depressive symptoms from pre-intervention to post-intervention as measured by the depression subscale of the DASS.
Time frame: Baseline to endpoint [Week 6]
Depression will be measured by the depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale measures of the severity of depressive symptoms. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no symptoms.
10 secondary outcomes
Change in anxiety measure scores pre-intervention to post-active learning phase as measured by HAM-A
Time frame: Baseline to end of active learning phase [week 4]
Change in anxiety measure scores pre-intervention to post-active learning phase as measured by the anxiety subscale of the DASS.
Time frame: Baseline to end of active learning phase [week 4]
Change in depression measure scores pre-intervention to post-active learning phase as measured by HAM-D.
Time frame: Baseline to end of active learning phase [week 4]
Change in depression measure scores pre-intervention to post-active learning phase as measured by the depression subscale of the DASS.
Time frame: Baseline to end of active learning phase [week 4]
Change in social anxiety from pre-intervention to post-intervention as measured by LSAS.
Time frame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Change in anxiety sensitivity from pre-intervention to post-intervention as measured by ASI.
Time frame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Change in avoidance from pre-intervention to post-intervention as measured by MEAQ.
Time frame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Change in anhedonia from pre-intervention to post-intervention as measured by TEPS.
Time frame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Change in Negative affect from pre-intervention to post-intervention as measured by PANAS
Time frame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Bipolar symptoms from pre-intervention to post-intervention as measured by ISS.
Time frame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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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.
Jennifer Bress, Ph.D. 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 Personalized MAYA Mobile App and General MAYA Mobile App in people with Anxiety Disorders and Symptoms 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 7 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maddy Schier ((646) 289-5271 ext. 720, mas4019@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety symptoms from pre-intervention to post-intervention as measured by the HAM-A. (time frame: Baseline to endpoint [Week 6]). The study lists 4 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 22 May 2026.