Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Change in Anxious Symptoms From Baseline to End of Treatment (Week 6)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Social Support
Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks.
Intervention: Maya mobile app (Behavioral)
Social Support
Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks.
Intervention: Social Support (Behavioral)
Gain Framed
Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks.
Intervention: Maya mobile app (Behavioral)
Gain Framed
Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks.
Intervention: Gain Framed (Behavioral)
Loss Framed
Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks.
Intervention: Maya mobile app (Behavioral)
Loss Framed
Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks.
Intervention: Loss Framed (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Mean Number of Sessions Completed(End of intervention (week 6))
- Mean Rating Score on the Mobile Application Rating Scale(End of intervention (week 6))