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Personalized Mobile Cognitive Behavioral Therapy Application

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Enrolling

Conditions

Anxiety Disorders and Symptoms
Bipolar Disorder
Depression
Symptoms

Treatments

Behavioral: Personalized MAYA Mobile App
Behavioral: General MAYA Mobile App

Study type

Interventional

Funder types

Other

Identifiers

NCT05699525
21-09023953

Details and patient eligibility

About

This study aims to compare the effectiveness of a standard mobile iPhone cognitive behavioral therapy program to a personalized mobile iPhone 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 magnetic resonance imaging (MRI) and 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.

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18 to 25 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Personalized
Experimental group
Description:
Participants receive the personalized Maya app intervention for 6 weeks
Treatment:
Behavioral: Personalized MAYA Mobile App
General Non-Personalized
Active Comparator group
Description:
Participants receive the general MAYA app intervention for 6 weeks
Treatment:
Behavioral: General MAYA Mobile App

Trial contacts and locations

1

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Central trial contact

Zareen Mir; Maddy Schier

Data sourced from clinicaltrials.gov

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