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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Support | Experimental | Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks. |
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| Gain Framed | Experimental | Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks. |
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| Loss Framed | Experimental | Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 6 (end of intervention) |
| 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. | Baseline to week 6 (end of intervention) |
| 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. | Baseline to week 6 (end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of intervention (week 6) |
| Mean Rating Score on the Mobile Application Rating Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faith Gunning, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39163044 | Derived | Bress JN, Falk A, Schier MM, Jaywant A, Moroney E, Dargis M, Bennett SM, Scult MA, Volpp KG, Asch DA, Balachandran M, Perlis RH, Lee FS, Gunning FM. Efficacy of a Mobile App-Based Intervention for Young Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2428372. doi: 10.1001/jamanetworkopen.2024.28372. |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | units on a scale | Baseline to week 6 (end of intervention) |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin abrasion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maddy Schier | Weill Cornell Medicine | (646) 289-5271 | 720 | mas4019@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2023 | Jul 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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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.
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| 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. |
|
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. |
| End of intervention (week 6) |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| The Anxiety and Related Disorders Interview Schedule for DSM-5 (adult) Clinical Severity Rating | Clinical severity rating (CSR) of the primary diagnosis derived from the interview. CSR ratings range from 0 (absent) to 8 (very severely disturbing/disabling). The CSR takes into account intensity and frequency of the symptoms as well as interference of functioning. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Rating Scale for Anxiety (HAM-A) | The HAM-A is a clinician-administered 14-item measure of the severity of both psychic and somatic anxiety, with a total score range of 0-56. Total scores of ≤ 7 indicate no/minimal anxiety, 8-14 indicate mild anxiety, 15-23 indicate moderate anxiety, and ≥ 24 indicate severe anxiety. | Mean | Standard Deviation | units on a scale |
|
| Hamilton Depression Rating Scale (HAM-D) | The 24-item HAM-D measures depressive symptoms and has a total score range of 0-76, with ≤ 7 indicating absence of depression, 8-14 indicating borderline to mild depression, 15-25 indicating moderate to marked depression, and ≥ 26 indicating severe to extreme depression. | Mean | Standard Deviation | units on a scale |
|
| Anxiety Sensitivity Index (ASI) | The ASI consists of 18 self-report items across three domains (physiological, cognitive, and social concerns) assessing fear of the consequences of experiencing anxiety (anxiety sensitivity, or "fear of fear"). The toal score ranges from 0-72, with higher scores indicating greater anxiety sensitivity. | Mean | Standard Deviation | units on a scale |
|
| Liebowitz Social Anxiety Scale (LSAS) | The LSAS is a 24-item self-report rating scale measuring social anxiety, with a total score range of 0-144. Lower scores indicate lower levels of social anxiety, and higher scores indicate higher levels of social anxiety. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Baseline to week 6 (end of intervention) |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | Baseline to week 6 (end of intervention) |
|
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| 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. | Posted | Mean | Standard Error | sessions | End of intervention (week 6) |
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| 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. | 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. | Posted | Mean | Standard Error | units on a scale | End of intervention (week 6) |
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| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | 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. | 0 | 30 | 0 | 30 | 1 | 30 |
| EG002 | 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. | 0 | 11 | 0 | 11 | 0 | 11 |
| root canal | Surgical and medical procedures | Non-systematic Assessment |
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