Anxiety Disorders and SymptomsNCT05130281
Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
A study testing Maya mobile app, Social Support and Gain Framed in people with Anxiety Disorders and Symptoms, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Anxiety Disorders and Symptoms
- What is being tested?
- Maya mobile app, Social Support and Gain Framed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2021to 8 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
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.
Read the 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).
- Conditions
- Anxiety Disorders and Symptoms
- Being tested
- Maya mobile app, Social Support, Gain Framed, Loss Framed
- Keywords
- anxiety, mental health, adolescents, young adults, CBT, mobile app, Cognitive Behavior Therapy
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maya mobile appBehavioural
The Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.
Social SupportBehavioural
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 FramedBehavioural
Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message.
Loss FramedBehavioural
Participants lost points and badges for not completing sessions, homework, and skills on time and receive post session feedback via text message.
| Study group | Role | What they receive |
|---|---|---|
| Social Support | Experimental | Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks. Receives: Behavioral: Maya mobile app; Behavioral: Social Support |
| Gain Framed | Experimental | Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks. Receives: Behavioral: Maya mobile app; Behavioral: Gain Framed |
| Loss Framed | Experimental | Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks. Receives: Behavioral: Maya mobile app; Behavioral: Loss Framed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to week 6 (end of intervention)
Secondary outcomes (2)
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.
Measured: End of intervention (week 6)
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.
Measured: End of intervention (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start18 Jun 2021
- Primary completion3 Nov 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorders and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faith Gunning, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130281
- Sponsor's protocol ID
- 1803019086
- Status last verified
- Oct 2024
- First submitted
- 11 Nov 2021
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39163044
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders
- ClinicalTrials.gov ID
- NCT05130281
- Acronym / sponsor ID
- 1803019086
- Conditions
- Anxiety Disorders and Symptoms
- Keywords
- anxiety, mental health, adolescents, young adults, CBT, mobile app, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Social Support | Experimental | Behavioral: Maya mobile app, Behavioral: Social SupportParticipants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks. |
| Gain Framed | Experimental | Behavioral: Maya mobile app, Behavioral: Gain FramedParticipants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks. |
| Loss Framed | Experimental | Behavioral: Maya mobile app, Behavioral: Loss FramedParticipants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maya mobile appThe Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety. | Behavioural | Gain Framed, Loss Framed, Social Support |
| Social SupportParticipants 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. | Behavioural | Social Support |
| Gain FramedParticipants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message. | Behavioural | Gain Framed |
| Loss FramedParticipants lost points and badges for not completing sessions, homework, and skills on time and receive post session feedback via text message. | Behavioural | Loss Framed |
Primary outcome
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.
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 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.
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 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.
2 secondary outcomes
Mean Number of Sessions Completed
Time frame: End of intervention (week 6)
Mean Rating Score on the Mobile Application Rating Scale
Time frame: End of intervention (week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39163044Bress 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faith Gunning, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maya mobile app, Social Support and Gain Framed in people with Anxiety Disorders and Symptoms, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxious Symptoms From Baseline to End of Treatment (Week 6) (time frame: Baseline to week 6 (end of intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05130281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.