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Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

Primary Purpose

Anxiety Disorders and Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maya mobile app
Social Support
Gain Framed
Loss Framed
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders and Symptoms focused on measuring anxiety, mental health, adolescents, young adults, CBT, mobile app, Cognitive Behavior Therapy

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Social Support

Gain Framed

Loss Framed

Arm Description

Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks.

Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks.

Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 11, 2021
Last Updated
January 31, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT05130281
Brief Title
Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
Official Title
Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
November 3, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders and Symptoms
Keywords
anxiety, mental health, adolescents, young adults, CBT, mobile app, Cognitive Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Support
Arm Type
Experimental
Arm Description
Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks.
Arm Title
Gain Framed
Arm Type
Experimental
Arm Description
Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks.
Arm Title
Loss Framed
Arm Type
Experimental
Arm Description
Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Maya mobile app
Intervention Description
The Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.
Intervention Type
Behavioral
Intervention Name(s)
Social Support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gain Framed
Intervention Description
Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message.
Intervention Type
Behavioral
Intervention Name(s)
Loss Framed
Intervention Description
Participants lost points and badges for not completing sessions, homework, and skills on time and receive post session feedback via text message.
Primary Outcome Measure Information:
Title
Change in anxious symptoms from baseline to end of treatment (Week 6)
Description
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.
Time Frame
Baseline to week 6 (end of intervention)
Title
Change in anxious symptoms from baseline to end of treatment (Week 6)
Description
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.
Time Frame
Baseline to week 6 (end of intervention)
Title
Change in anxious symptoms from baseline to end of treatment (Week 6)
Description
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.
Time Frame
Baseline to week 6 (end of intervention)
Secondary Outcome Measure Information:
Title
Number of sessions completed
Description
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.
Time Frame
End of intervention (week 6)
Title
Mean rating score on the Mobile Application Rating Scale
Description
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.
Time Frame
End of intervention (week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith Gunning, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

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