Anxiety Disorders and Symptoms
Conditions
Keywords
anxiety, mental health, adolescents, young adults, CBT, mobile app, Cognitive Behavior Therapy
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).
Interventions
BEHAVIORALMaya mobile app
The Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.
BEHAVIORALSocial 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.
BEHAVIORALGain Framed
Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message.
BEHAVIORALLoss Framed
Participants lost points and badges for not completing sessions, homework, and skills on time and receive post session feedback via text message.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Sessions Completed | 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. |
| Mean Rating Score on the Mobile Application Rating Scale | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through online advertisements, local college and university e-mail lists, and physical flyers posted across local colleges and universities between June 2021 and September 2022. The first particpant was enrolled 6/18/2021 and the last participant was enrolled 9/8/2022.
Pre-assignment details
Eligible participants had a primary diagnosis of an anxiety disorder, were ages 18-25, and fluent in English. Exclusion criteria included current cognitive behavioral therapy, change in psychotropic medication dose in the past 12 weeks, or suicidal ideation with intent and/or plan. Of 68 people evaluated, 59 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Social Support Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks.
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.
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. | 18 |
| Gain Framed Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks.
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.
Gain Framed: Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message. | 30 |
| Loss Framed Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks.
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.
Loss Framed: Participants lost points and badges for not completing sessions, homework, and skills on time and receive post session feedback via text message. | 11 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Social Support | Gain Framed | Loss Framed | Total |
|---|---|---|---|---|
| Age, Continuous | 24 years STANDARD_DEVIATION 1.2 | 22.9 years STANDARD_DEVIATION 1.9 | 22.4 years STANDARD_DEVIATION 2.4 | 23.1 years STANDARD_DEVIATION 1.9 |
| Anxiety Sensitivity Index (ASI) | 22.4 units on a scale STANDARD_DEVIATION 13.3 | 28.1 units on a scale STANDARD_DEVIATION 15.1 | 22.3 units on a scale STANDARD_DEVIATION 12.4 | 25.3 units on a scale STANDARD_DEVIATION 14.2 |
| Education Associate degree | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Education College | 12 Participants | 16 Participants | 4 Participants | 32 Participants |
| Education Did not answer | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Education Graduate/Professional | 4 Participants | 7 Participants | 1 Participants | 12 Participants |
| Education High school | 0 Participants | 4 Participants | 2 Participants | 6 Participants |
| Education Some college | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 28 Participants | 7 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Hamilton Depression Rating Scale (HAM-D) | 15.9 units on a scale STANDARD_DEVIATION 6.3 | 16.4 units on a scale STANDARD_DEVIATION 6.2 | 14.4 units on a scale STANDARD_DEVIATION 4.3 | 15.9 units on a scale STANDARD_DEVIATION 5.9 |
| Hamilton Rating Scale for Anxiety (HAM-A) | 14.3 units on a scale STANDARD_DEVIATION 5.8 | 16.7 units on a scale STANDARD_DEVIATION 7.3 | 11.5 units on a scale STANDARD_DEVIATION 3.4 | 15.0 units on a scale STANDARD_DEVIATION 6.5 |
| Liebowitz Social Anxiety Scale (LSAS) | 47.1 units on a scale STANDARD_DEVIATION 27.3 | 59.3 units on a scale STANDARD_DEVIATION 26.8 | 44.2 units on a scale STANDARD_DEVIATION 29.7 | 52.7 units on a scale STANDARD_DEVIATION 27.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 14 Participants | 2 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 7 Participants | 12 Participants | 6 Participants | 25 Participants |
| Sex/Gender, Customized Gender Did not answer | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Gender Female | 18 Participants | 23 Participants | 5 Participants | 46 Participants |
| Sex/Gender, Customized Gender Male | 0 Participants | 6 Participants | 4 Participants | 10 Participants |
| Sex/Gender, Customized Gender Non-binary | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| The Anxiety and Related Disorders Interview Schedule for DSM-5 (adult) Clinical Severity Rating | 5.1 units on a scale STANDARD_DEVIATION 0.7 | 5.4 units on a scale STANDARD_DEVIATION 0.8 | 5.0 units on a scale STANDARD_DEVIATION 0.8 | 5.2 units on a scale STANDARD_DEVIATION 0.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 30 | 0 / 11 |
| other Total, other adverse events | 1 / 18 | 1 / 30 | 0 / 11 |
| serious Total, serious adverse events | 0 / 18 | 0 / 30 | 0 / 11 |
Outcome results
Primary
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.
Time frame: Baseline to week 6 (end of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Support | Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 4.78 units on a scale | Standard Error 1.03 |
| Gain Framed | Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 6.93 units on a scale | Standard Error 1.41 |
| Loss Framed | Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 6.09 units on a scale | Standard Error 1.54 |
Primary
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.
Time frame: Baseline to week 6 (end of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Support | Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 7.22 units on a scale | Standard Error 2.19 |
| Gain Framed | Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 11.73 units on a scale | Standard Error 2.16 |
| Loss Framed | Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 12.27 units on a scale | Standard Error 3.86 |
Primary
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 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.
Time frame: Baseline to week 6 (end of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Support | Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 36.06 units on a scale | Standard Error 5.72 |
| Gain Framed | Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 43.77 units on a scale | Standard Error 3.91 |
| Loss Framed | Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) | 27.45 units on a scale | Standard Error 7.14 |
Secondary
Mean Number of Sessions Completed
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.
Time frame: End of intervention (week 6)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Support | Mean Number of Sessions Completed | 11.56 sessions | Standard Error 0.2 |
| Gain Framed | Mean Number of Sessions Completed | 10.67 sessions | Standard Error 0.41 |
| Loss Framed | Mean Number of Sessions Completed | 10.00 sessions | Standard Error 0.88 |
Secondary
Mean Rating Score on the Mobile Application Rating Scale
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.
Time frame: End of intervention (week 6)
Population: 2 participants in the loss framed arm, and 1 participant in the gain framed arm had missing data from various timepoints for this measure, and therefore were not included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social Support | Mean Rating Score on the Mobile Application Rating Scale | 4.19 units on a scale | Standard Error 0.08 |
| Gain Framed | Mean Rating Score on the Mobile Application Rating Scale | 4.18 units on a scale | Standard Error 0.1 |
| Loss Framed | Mean Rating Score on the Mobile Application Rating Scale | 3.91 units on a scale | Standard Error 0.15 |