Clinical trial NCT05130281: Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
Official title: Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Keywords: anxiety
mental health
adolescents
young adults
CBT
mobile app
Cognitive Behavior Therapy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Anxious Symptoms From Baseline to End of Treatment (Week 6)
timeFrame: Baseline to week 6 (end of intervention)
measure: Change in Anxious Symptoms From Baseline to End of Treatment (Week 6)
timeFrame: Baseline to week 6 (end of intervention)
measure: Change in Anxious Symptoms From Baseline to End of Treatment (Week 6)
timeFrame: Baseline to week 6 (end of intervention)
Secondary outcomes:
measure: Mean Number of Sessions Completed
timeFrame: End of intervention (week 6)
measure: Mean Rating Score on the Mobile Application Rating Scale
timeFrame: End of intervention (week 6)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Faith Gunning, PhD
role: PRINCIPAL_INVESTIGATOR
References: