Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-18

Study Completion Date

2022-12-08

Brief Summary

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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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Detailed Description

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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).

Conditions

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Anxiety Disorders and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Social Support

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

Group Type EXPERIMENTAL

Maya mobile app

Intervention Type 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

Intervention Type 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

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

Group Type EXPERIMENTAL

Maya mobile app

Intervention Type BEHAVIORAL

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

Gain Framed

Intervention Type BEHAVIORAL

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

Loss Framed

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

Group Type EXPERIMENTAL

Maya mobile app

Intervention Type BEHAVIORAL

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

Loss Framed

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Gain Framed

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No