Mobile CBT for Middle Aged and Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorWeill Medical College of Cornell University
About this trial
This study aims to assess a mobile app called MAYA for use in middle-aged and older adults with anxiety or mood disorders. The MAYA app is designed to teach coping skills for anxiety and depression that are drawn from cognitive behavioral therapy. Participants will be asked to use the app for at least two days a week, 20 minutes on each day, for six weeks. Participants will have weekly check-ins as well as longer assessments at the beginning of the study, week 3, week 6 (end of treatment), and week 12 (follow up). During assessments, participants will answer brief questionnaires designed to assess their symptoms and impressions of the app. The main hypotheses of the study are that participants will complete most of the assigned sessions and that they will rate their impressions of the app highly. The secondary hypotheses are that symptoms of depression and anxiety will decrease with use of the MAYA app.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40 or older
Primary diagnosis of an anxiety or depressive disorder as determined by a clinical severity rating score of 4 or greater on the Anxiety Disorders Interview Schedule (ADIS).
Mini Mental Status Exam (MMSE) no more than 1 SD below the mean score for patient's age and education. If the remote version of the MMSE is used (e.g. during an evaluation on Zoom), the remote MMSE score will be converted to a standard MMSE score.
Access to an Apple iPhone, iPad, or Android device.
Disqualifiers
Lifetime diagnosis of a bipolar or psychotic disorder.
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.
Trial design
Design model
Single group
Treatments tested in this trial
MAYA Mobile Application
BehavioralThe mobile cognitive behavioral therapy (CBT) application, MAYA, teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, exposure and psychoeducation (i.e. information about anxiety and depression). The application includes an interactive dashboard to provide the user with statistics for tracking progress toward their goals. Although the MAYA application is new, its content and structure are similar to how CBT- a well-established and widely used psychosocial intervention - is commonly delivered in the more traditional setting of a psychotherapist's office.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: MAYA Mobile AppExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability of the MAYA application as measured by mean uMARS scores at Baseline
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Time frame
Week 1 (Baseline)2
Acceptability of the MAYA application as measured by mean uMARS scores at Midpoint
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Time frame
Week 3 (Midpoint)3
Acceptability of the MAYA application as measured by mean uMARS scores at Endpoint
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Time frame
Week 6 (Endpoint)4
Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Endpoint
Total number of sessions completed by the end of the administered intervention
Time frame
Week 6 (Endpoint)Secondary outcomes
1
Change in anxiety symptoms 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, Week 6 (Endpoint), and Week 12 (Follow Up)2
Change in depressive symptoms as measured by the MADRS
Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is a 10-item questionnaire measuring the severity of depression symptoms. Scores range from 0 to 60, where higher scores indicate higher severity of depressive symptoms.
Time frame
Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
Joseph S. Sanchez Foundation
Collaborator
Source ClinicalTrials.gov