Clinical trial NCT05699525: Personalized Mobile Cognitive Behavioral Therapy Application
Official title: Efficacy of Personalized Mobile Cognitive Behavioral Therapy Targeting Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Depression
Bipolar Disorder
Symptoms
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Children's Health Fund
First posted: 2023-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

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

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.

Primary outcomes:
measure: Change in anxiety symptoms from pre-intervention to post-intervention as measured by the HAM-A.
timeFrame: Baseline to endpoint [Week 6]
measure: Change in depressive symptoms from pre-intervention to post-intervention as measured by HAM-D.
timeFrame: Baseline to endpoint [Week 6]
measure: Change in anxiety symptoms from pre-intervention to post-intervention as measured by the anxiety subscale of the DASS.
timeFrame: Baseline to endpoint [Week 6]
measure: Change in depressive symptoms from pre-intervention to post-intervention as measured by the depression subscale of the DASS.
timeFrame: Baseline to endpoint [Week 6]
Secondary outcomes:
measure: Change in anxiety measure scores pre-intervention to post-active learning phase as measured by HAM-A
timeFrame: Baseline to end of active learning phase [week 4]
measure: Change in anxiety measure scores pre-intervention to post-active learning phase as measured by the anxiety subscale of the DASS.
timeFrame: Baseline to end of active learning phase [week 4]
measure: Change in depression measure scores pre-intervention to post-active learning phase as measured by HAM-D.
timeFrame: Baseline to end of active learning phase [week 4]
measure: Change in depression measure scores pre-intervention to post-active learning phase as measured by the depression subscale of the DASS.
timeFrame: Baseline to end of active learning phase [week 4]
measure: Change in social anxiety from pre-intervention to post-intervention as measured by LSAS.
timeFrame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
measure: Change in anxiety sensitivity from pre-intervention to post-intervention as measured by ASI.
timeFrame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
measure: Change in avoidance from pre-intervention to post-intervention as measured by MEAQ.
timeFrame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
measure: Change in anhedonia from pre-intervention to post-intervention as measured by TEPS.
timeFrame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
measure: Change in Negative affect from pre-intervention to post-intervention as measured by PANAS
timeFrame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
measure: Bipolar symptoms from pre-intervention to post-intervention as measured by ISS.
timeFrame: Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jennifer Bress, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: