- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05699525
Personalized Mobile Cognitive Behavioral Therapy Application
Efficacy of Personalized Mobile Cognitive Behavioral Therapy Targeting Anxiety and Depression
Study Overview
Status
Intervention / Treatment
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 magnetic resonance imaging (MRI) and/or electroencephalographic (EEG) recording at the baseline and end of intervention (week 6).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maddy Schier
- Phone Number: 720 (646) 289-5271
- Email: mas4019@med.cornell.edu
Study Contact Backup
- Name: Zareen Mir
- Phone Number: 705 (646)-289-5271
- Email: zam4005@med.cornell.edu
Study Locations
-
-
New York
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New York, New York, United States, 10065
- Weill Cornell Medical College
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Contact:
- Maddy Schier
- Phone Number: 720 (646) 289-5271
- Email: mas4019@med.cornell.edu
-
Contact:
- Jennifer Bress, Ph.D
- Phone Number: 914-997-8683
- Email: jeb2061@med.cornell.edu
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Principal Investigator:
- Jennifer Bress, Ph.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Personalized
Participants receive the personalized Maya app intervention for 6 weeks
|
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.
|
Active Comparator: General Non-Personalized
Participants receive the general MAYA app intervention for 6 weeks
|
New material will be introduced to participants over all the six weeks of the intervention and will include all application modules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
|
Baseline to endpoint [Week 6]
|
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.
|
Baseline to endpoint [Week 6]
|
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.
|
Baseline to endpoint [Week 6]
|
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.
|
Baseline to endpoint [Week 6]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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]
|
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 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
|
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]
|
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.
|
Baseline to end of active learning phase [week 4]
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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]
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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.
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Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
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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]
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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.
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Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
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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]
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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.
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Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
|
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]
|
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.
|
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]
|
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.
|
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]
|
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.
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Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
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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]
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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.
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Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
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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]
|
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.
|
Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jennifer Bress, Ph.D., Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-09023953
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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