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Completed

NCT Number: NCT05130281

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.

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Key information

Conditions

Anxiety Disorders and Symptoms Anxiety Disorders Behavior Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College

New York, 10065, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maya mobile app

Behavioral

The Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.

Social Support

Behavioral

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

Behavioral

Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message.

Loss Framed

Behavioral

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

Primary outcomes

  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 with a total score range of 0-144. Higher scores, defined by a total score range of 50-95 or greater, indicate greater fear and avoidance severity and lower scores, defined by a total score range of 0-49, indicate mild to no fear or avoidance.

Secondary outcomes

  1. Mean Number of Sessions Completed

    Time frame: End of intervention (week 6)

    Mean number of sessions completed in the mobile app over the course of treatment. 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)

    The mean rating score is a average of four rating sub-scales (engagement, functionality, aesthetics, quality of information) 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. The mean rating score has a total range of 1-5, with higher total scores, defined by a mean score of 4 or greater, indicating greater application feasibility and lower scores, defined by a mean score of 3 or lower, indicating poorer application feasibility.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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