Personalized Mobile Cognitive Behavioral Therapy Application
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Personalized MAYA Mobile App
BehavioralAll 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 App
BehavioralNew material will be introduced to participants over all the six weeks of the intervention and will include all application modules.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PersonalizedExperimental treatment 1 intervention
Group B: General Non-PersonalizedActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to endpoint [Week 6]2
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.
Time frame
Baseline to endpoint [Week 6]3
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.
Time frame
Baseline to endpoint [Week 6]4
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.
Time frame
Baseline to endpoint [Week 6]Secondary outcomes
1
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.
Time frame
Baseline to end of active learning phase [week 4]2
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.
Time frame
Baseline to end of active learning phase [week 4]3
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.
Time frame
Baseline to end of active learning phase [week 4]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.
Time frame
Baseline to end of active learning phase [week 4]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
Children's Health Fund
Collaborator
Source ClinicalTrials.gov