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Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05130281
Recruitment Status : Completed
First Posted : November 23, 2021
Last Update Posted : February 1, 2023
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders and Symptoms Behavioral: Maya mobile app Behavioral: Social Support Behavioral: Gain Framed Behavioral: Loss Framed Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized clinical trial designed to assess the feasibility of Maya, an app-based CBT intervention, and provide preliminary efficacy data for three different incentive strategies. Participants will be randomized to one of three incentive conditions: 1) a social support condition, 2) a gain-framed condition in which participants can earn "points" for completing assigned therapy sessions, and 3) a loss-framed condition in which participants begin with a specified number of points that they can lose for failing to complete assigned therapy sessions on time.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
Actual Study Start Date : June 18, 2021
Actual Primary Completion Date : November 3, 2022
Actual Study Completion Date : December 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in anxious symptoms from baseline to end of treatment (Week 6) [ Time Frame: Baseline to week 6 (end of intervention) ]
    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.

  2. Change in anxious symptoms from baseline to end of treatment (Week 6) [ Time Frame: Baseline to week 6 (end of intervention) ]
    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.

  3. Change in anxious symptoms from baseline to end of treatment (Week 6) [ Time Frame: Baseline to week 6 (end of intervention) ]
    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.


Secondary Outcome Measures :
  1. Number of sessions completed [ Time Frame: End of intervention (week 6) ]
    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.

  2. Mean rating score on the Mobile Application Rating Scale [ Time Frame: End of intervention (week 6) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130281


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Faith Gunning, PhD Weill Medical College of Cornell University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT05130281    
Other Study ID Numbers: 1803019086
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: February 1, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
anxiety
mental health
adolescents
young adults
 CBT
mobile app
Cognitive Behavior Therapy
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders