Personalized Mobile Cognitive Behavioral Therapy Application
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized MAYA Mobile App, General MAYA Mobile App.
- Who it may be relevant to
- Registry conditions: Anxiety Disorders and Symptoms, Depression, Bipolar Disorder, Symptoms. Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Personalized Mobile Cognitive Behavioral Therapy Targeting Anxiety and Depression
Overview
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).
Interventions
- Behavioral Personalized MAYA Mobile App
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. - Behavioral General MAYA Mobile App
New material will be introduced to participants over all the six weeks of the intervention and will include all application modules.
Primary outcome measures
- Change in anxiety symptoms from pre-intervention to post-intervention as measured by the HAM-A. [Time frame: 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]]
- 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]]
- 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]]
Secondary outcome measures (10)
- 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]]
Eligibility criteria
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, iPad, or Android device.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Weill Cornell Medical College — New York
Identifiers
NCT: NCT05699525 · 21-09023953