Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

This study aims to examine different ways of motivating people to make use of Maya, a mobile cognitive behavior therapy (CBT) program for adolescents and young adults experiencing anxiety symptoms, and to assess whether social supports are as efficacious, or more efficacious, than other non-monetary incentives. Subjects will use the Maya app for at least 20 minutes per day, 2 days per week, for 6 weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and an optional magnetic resonance imaging (MRI) recording.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders and Symptoms
• Intervention / Treatment: Behavioral: Maya mobile app; Behavioral: Social Support; Behavioral: Gain Framed; Behavioral: Loss Framed

Detailed Description

There is a growing need for easily accessed anxiety treatments designed for young adults. Mobile app-based interventions can be disseminated more broadly than traditional psychosocial interventions and may be particularly appealing to this age group, which uses mobile devices frequently. Mobile apps can also collect real-time data about patient symptom severity and provide tailored, in-the-moment coping strategies.

This study aims to examine different ways of motivating people to make use of Maya, a mobile cognitive behavior therapy (CBT) app for adolescents and young adults experiencing anxiety symptoms, and to assess whether social supports are as efficacious, or more efficacious, than other non-monetary incentives. Young adults with anxiety will be randomized to one of three conditions: a social support condition, a gain-framed condition in which participants can earn "points" for completing their assigned sessions, and a loss-framed condition in which participants lose "points" for failing to complete their assigned sessions. Subjects will use the Maya app for at least 20 minutes per day, 2 days per week, for 6 weeks and will complete assessments at baseline, week 3, week 6 (end of treatment), and a follow-up assessment at week 12. Subjects may also choose to complete an optional magnetic resonance imaging (MRI) recording at the baseline and end of treatment (week 6).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between the ages of 18 and 25
• Primary diagnosis of an anxiety disorder, as determined by a score of 4 on the Clinical Severity Rating from the Anxiety Disorders Interview Schedule (ADIS)

Exclusion Criteria:

• Score of < 4 on the ADIS
• Primary psychiatric diagnosis other than an anxiety disorder
• Currently in cognitive behavioral therapy outside of the study
• Change in dose of a psychiatric medication in the past 12 weeks
• Intent or plan to attempt suicide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Support; Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks.	Behavioral: Maya mobile app; The Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.; Behavioral: Social Support; Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message. Participants can identify a person they know to receive updates about their progress and support them throughout their time in the program. Participants will not be required to choose a person they know to receive updates about their use of the program; instead, they can choose to have a member of the study team serve as their social support if they are assigned to this condition.
Experimental: Gain Framed; Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks.	Behavioral: Maya mobile app; The Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.; Behavioral: Gain Framed; Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message.
Experimental: Loss Framed; Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks.	Behavioral: Maya mobile app; The Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.; Behavioral: Loss Framed; Participants lost points and badges for not completing sessions, homework, and skills on time and receive post session feedback via text message.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxious symptoms from baseline to end of treatment (Week 6)	Change in anxiety between the three incentive conditions will be measured using the Hamilton Rating Scale for Anxiety (HAM-A), a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety, where higher scores, defined by a score range of 18-56, indicate a greater presence of symptoms and lower scores, defined by a score range of 0-17, indicate mild to no anxiety symptoms.	Baseline to week 6 (end of intervention)
Change in anxious symptoms from baseline to end of treatment (Week 6)	Change in anxiety between the three incentive conditions will be measured using the Anxiety Sensitivity Index (ASI). The ASI is an 18-item scale containing three subscales measuring physical, cognitive, and social concerns regarding anxiety. Higher scores, defined by a score range of 18-72, reflect greater self-reported concern and lower scores, defined by a score range of 0-17, reflect little self-reported concern.	Baseline to week 6 (end of intervention)
Change in anxious symptoms from baseline to end of treatment (Week 6)	Change in anxiety between the three incentive conditions will be measured using the the Leibowitz Social Anxiety Scale (LSAS). The LSAS is a 24-item scale measuring fear and avoidance across social situations. Higher scores, defined by a score range of 50-95 or greater, indicate greater fear and avoidance severity and lower scores, defined by a score range of 0-49, indicate mild to no fear or avoidance.	Baseline to week 6 (end of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sessions completed	Number of sessions completed in the mobile app over the course of treatment will be totaled. A greater number of sessions completed over the course of treatment will indicate greater engagement.	End of intervention (week 6)
Mean rating score on the Mobile Application Rating Scale	Average of all three rating score on the uMARS throughout the intervention (average of week 1, 3, and 6) for each participant. The Mobile Application Rating Scale (uMARS) is a 26-item measure of mobile application engagement, functionality, aesthetics, quality of information, and perceived impact. Higher scores, defined by a mean score of 4 or greater, indicate greater application feasibility and lower scores, defined by a mean score of 3 or lower, indicate poorer application feasibility.	End of intervention (week 6)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: mental health; anxiety; adolescents; young adults; CBT; Cognitive Behavior Therapy; mobile app
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1803019086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No