Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

Anxiety Disorders and Symptoms Clinical Trial

Official title:

Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130281
• Other study ID #: 1803019086
• Status: Completed
• Phase: N/A
• Start date: June 18, 2021
• Est. completion date: December 8, 2022

Study information

• Verified date: January 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 8, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Disorders and Symptoms

Intervention

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.
• 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.
• Gain Framed
Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message.
• Loss Framed
Participants lost points and badges for not completing sessions, homework, and skills on time and receive post session feedback via text message.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)