Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

• ClinicalTrials.gov Identifier: NCT05130281
• Recruitment Status: Completed
• First Posted: November 23, 2021
• Last Update Posted: February 1, 2023
• Sponsor: Weill Medical College of Cornell University
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Tracking Information

• First Submitted Date: November 11, 2021
• First Posted Date: November 23, 2021
• Last Update Posted Date: February 1, 2023
• Actual Study Start Date: June 18, 2021
• Actual Primary Completion Date: November 3, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 11, 2021)

• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 11, 2021)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
• Official Title: Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
• 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.

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
• Study Phase: Not Applicable

Study Design

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

• Condition: 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.
• 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.
• Behavioral: Gain Framed
  Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message.
• 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.

Study Arms

• Experimental: Social Support
  Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks.
  Interventions:

  • Behavioral: Maya mobile app
  • Behavioral: Social Support
• Experimental: Gain Framed
  Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks.
  Interventions:

  • Behavioral: Maya mobile app
  • Behavioral: Gain Framed
• Experimental: Loss Framed
  Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks.
  Interventions:

  • Behavioral: Maya mobile app
  • Behavioral: Loss Framed

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2023): 60
• Original Estimated Enrollment (submitted: November 11, 2021): 120
• Actual Study Completion Date: December 8, 2022
• Actual Primary Completion Date: November 3, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 25 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05130281
• Other Study ID Numbers: 1803019086
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Weill Medical College of Cornell University
• Original Responsible Party: Same as current
• Current Study Sponsor: Weill Medical College of Cornell University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Faith Gunning, PhD; Weill Medical College of Cornell University

• PRS Account: Weill Medical College of Cornell University
• Verification Date: January 2023