AnxietyNCT06946823
Implementation of a Just-In-Time Adaptive Intervention for Adolescent Anxiety
A study testing Just-In-Time Adaptive Intervention for Adolescent Anxiety in people with Anxiety and Anxiety Disorders, run by Trustees of Dartmouth College.
Trial summary
The goal of this clinical trial is to evaluate a smartphone based just-in-time adaptive intervention (JITAI) tool to deliver somatic behavioral recommendations for anxiety management among youth. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Anxiety, Anxiety Disorders, Anxiety Disorder of Childhood
- What is being tested?
- Just-In-Time Adaptive Intervention for Adolescent Anxiety
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent (age 13-17 years old)
- New Hampshire resident
- Fluency in English
- Able to provide assent
- At least mild (≥5) anxiety based on the GAD-7 assessment
Who cannot join
- Under 13 years old
- Over 17 years old
- Not a New Hampshire resident
- Unable to provide assent
- Less than mild (<5) anxiety based on the GAD-7 assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Community-Engaged Design and Implementation of a Just-In-Time Adaptive Intervention (JITAI) to Improve Adolescent Anxiety in Rural Populations
The goal of this clinical trial is to evaluate a smartphone based just-in-time adaptive intervention (JITAI) tool to deliver somatic behavioral recommendations for anxiety management among youth. The main questions it aims to answer are:
- Is the JITAI tool acceptable among the adolescent study population?
- Is the JITAI tool feasible to deliver to the adolescent study population?
- Does the study support preliminary efficacy of the JITAI tool among the adolescent study population?
Read more
The tool will be pilot-tested among a sample of 50 rural adolescents experiencing elevated anxiety levels who will be randomly assigned to the JITAI tool or a waitlist control, for a treatment period of 3 months.
Participants will be asked to:
- Use the smartphone based JITAI tool which will deliver somatic behavioral recommendations intended to manage anxiety levels for a treatment period of 3 months
- Respond to the tool's prompts on a daily basis and follow the delivered behavioral recommendations
- Complete anxiety and interoception assessments at study start, study end (3 months), and one-month follow-up
- Complete usability and user experience instruments at study end (3 months)
Read the detailed description
It is imperative to improve the inclusive reach of effective anxiety treatments for adolescents. Anxiety disorders are among the most common psychiatric conditions in adolescents yet they are largely undertreated, particularly in rural areas. Behavioral interventions are efficacious in reducing anxiety symptoms while providing individuals with a toolkit of knowledge, skills, and techniques that empower self-care. As anxiety disorders involve an interconnected relationship between psychological and physiological processes, behavioral interventions that combine mind-body practices are coming to be seen as a particularly powerful therapeutic approach. Such treatments can include physical exercises, expressive movements, and other activities that emphasize interoception, autonomic reactivity, and the role of the body in processing and regulating emotions. However, research is needed to tailor these somatic approaches to an adolescent population, more rigorously evaluate their efficacy in diverse settings, and enhance their accessibility in traditionally underserved communities. Further, it is key to ensure such interventions are responsive and available in real-time, considering in-the-moment support is a critical aspect of quality anxiety care. Mobile technology is a promising platform for delivering personalized behavioral interventions at-scale and on-demand, including through emerging designs like just-in-time adaptive intervention(JITAI). This project aims to design, develop, and test a smartphone based JITAI tool to deliver somatic behavioral recommendations to manage anxiety levels. It will use a community-engaged research approach that partners with adolescents. Following qualitative needfinding to understand anxiety experiences and care needs as well as participatory design of the digital intervention, the tool will be pilot tested with a sample of 50 rural adolescents experiencing elevated anxiety levels who will be randomly assigned to the JITAI tool or a waitlist control, for a treatment period of 3 months. Objectives include demonstrating the acceptability, feasibility, and preliminary efficacy of this intervention approach.
- Conditions
- Anxiety, Anxiety Disorders, Anxiety Disorder of Childhood
- Being tested
- Just-In-Time Adaptive Intervention for Adolescent Anxiety
- Keywords
- Anxiety, Just-In-Time Adaptive Intervention, Smartphone, Behavioral Health, Community-Engaged Research, Adolescents, Rural, Digital Intervention, Participatory Design, Somatic
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just-In-Time Adaptive Intervention for Adolescent AnxietyDevice
A JITAI smartphone app to reduce anxiety levels among rural adolescents by delivering somatic-based activity recommendations
| Study group | Role | What they receive |
|---|---|---|
| Just-In-Time Adaptive Intervention for Adolescent Anxiety | Experimental | Participants in the Just-In-Time Adaptive Intervention for Adolescent Anxiety Arm will receive the just-in-time adaptive smartphone tool and be instructed to respond to the tool's prompts and follow delivered behavioral recommendations throughout the 3-month intervention period. Receives: Device: Just-In-Time Adaptive Intervention for Adolescent Anxiety |
| Waitlist Control | No intervention | Participants in the Waitlist Control Arm will receive the just-in-time adaptive smartphone tool following the completion of the 3-month intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Symptoms of Generalized Anxiety at 3 Months
Units on a scale measured through the GAD-7 (Generalized Anxiety Disorder-7) self-report questionnaire. Minimum score = 0, maximum score = 21, with a higher score indicating worse anxiety symptoms.
Measured: Baseline and 3 months
Change from Post-Treatment Symptoms of Generalized Anxiety to 1-month follow-up
Units on a scale measured through the GAD-7 (Generalized Anxiety Disorder-7) self-report questionnaire. Minimum score = 0, maximum score = 21, with a higher score indicating worse anxiety symptoms.
Measured: Post-Treatment (3 months after baseline) and 1-month follow-up (4 months after baseline)
Change from Baseline in Interoceptive Awareness at 3 Months
Units on a scale measured through the MAIA-Y (Multidimensional Assessment of Interoceptive Awareness for Youth) self-report questionnaire. Minimum score = 1, maximum score = 5, with higher scores indicating greater interoceptive awareness.
Measured: Baseline and 3 months
Change from Post-Treatment Interoceptive Awareness to 1-month follow-up
Units on a scale measured through the MAIA-Y (Multidimensional Assessment of Interoceptive Awareness for Youth) self-report questionnaire. Minimum score = 1, maximum score = 5, with higher scores indicating greater interoceptive awareness.
Measured: Post-Treatment (3 months after baseline) and 1-month follow-up (4 months after baseline)
Secondary outcomes (5)
Pragmatic and Hedonic User Experience
The AttrakDiff instrument assesses 4 dimensions of user experience (usability, stimulation, identity, and attractiveness) using a 7-point semantic differential scale where respondents choose between bipolar adjective pairs to produce an overall mean score. Minimum score = -3, maximum score = +3, where higher scores indicate a more usable and appealing tool.
Measured: 3 months after baseline
Technology Engagement
The GiggleGauge instrument assesses user engagement through a self-report questionnaire with a binary ordinal scale. Minimum score = 5, maximum score = 10, where higher scores indicate a more engaging tool.
Measured: 3 months after baseline
User Engagement
The User Engagement Scale (UES) instrument assesses user engagement with digital interventions through a self-report questionnaire on a 5-point Likert scale. Minimum score = 1, maximum score = 5, where higher scores indicate a more engaging tool.
Measured: 3 months after baseline
Percentage of app-based intervention activities completed by participants
Compliance will be assessed by calculating the percentage of assigned app-based intervention activities completed by each participant over the 3-month treatment period. Completion data will be automatically recorded by the app.
Measured: Baseline through 3-month treatment period
Number of participants who complete the study
Retention will be defined as the number of participants who remain enrolled and complete all study procedures through the end of the treatment period at 3 months.
Measured: End of treatment period (3 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study startJan 2027 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 50 rural adolescents experiencing elevated anxiety levels will be randomly assigned to the JITAI tool for a treatment period of 3 months or a waitlist control.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth L. Murnane, Trustees of Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946823
- Sponsor's protocol ID
- STUDY00033184
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Engaged Design and Implementation of a Just-In-Time Adaptive Intervention (JITAI) to Improve Adolescent Anxiety in Rural Populations
- ClinicalTrials.gov ID
- NCT06946823
- Acronym / sponsor ID
- STUDY00033184
- Conditions
- Anxiety, Anxiety Disorders, Anxiety Disorder of Childhood
- Keywords
- Anxiety, Just-In-Time Adaptive Intervention, Smartphone, Behavioral Health, Community-Engaged Research, Adolescents, Rural, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate a smartphone based just-in-time adaptive intervention (JITAI) tool to deliver somatic behavioral recommendations for anxiety management among youth. The main questions it aims to answer are:
- Is the JITAI tool acceptable among the adolescent study population?
- Is the JITAI tool feasible to deliver to the adolescent study population?
- Does the study support preliminary efficacy of the JITAI tool among the adolescent study population?
The tool will be pilot-tested among a sample of 50 rural adolescents experiencing elevated anxiety levels who will be randomly assigned to the JITAI tool or a waitlist control, for a treatment period of 3 months.
Participants will be asked to:
- Use the smartphone based JITAI tool which will deliver somatic behavioral recommendations intended to manage anxiety levels for a treatment period of 3 months
- Respond to the tool's prompts on a daily basis and follow the delivered behavioral recommendations
- Complete anxiety and interoception assessments at study start, study end (3 months), and one-month follow-up
- Complete usability and user experience instruments at study end (3 months)
Detailed description
It is imperative to improve the inclusive reach of effective anxiety treatments for adolescents. Anxiety disorders are among the most common psychiatric conditions in adolescents yet they are largely undertreated, particularly in rural areas. Behavioral interventions are efficacious in reducing anxiety symptoms while providing individuals with a toolkit of knowledge, skills, and techniques that empower self-care. As anxiety disorders involve an interconnected relationship between psychological and physiological processes, behavioral interventions that combine mind-body practices are coming to be seen as a particularly powerful therapeutic approach. Such treatments can include physical exercises, expressive movements, and other activities that emphasize interoception, autonomic reactivity, and the role of the body in processing and regulating emotions. However, research is needed to tailor these somatic approaches to an adolescent population, more rigorously evaluate their efficacy in diverse settings, and enhance their accessibility in traditionally underserved communities. Further, it is key to ensure such interventions are responsive and available in real-time, considering in-the-moment support is a critical aspect of quality anxiety care. Mobile technology is a promising platform for delivering personalized behavioral interventions at-scale and on-demand, including through emerging designs like just-in-time adaptive intervention(JITAI). This project aims to design, develop, and test a smartphone based JITAI tool to deliver somatic behavioral recommendations to manage anxiety levels. It will use a community-engaged research approach that partners with adolescents. Following qualitative needfinding to understand anxiety experiences and care needs as well as participatory design of the digital intervention, the tool will be pilot tested with a sample of 50 rural adolescents experiencing elevated anxiety levels who will be randomly assigned to the JITAI tool or a waitlist control, for a treatment period of 3 months. Objectives include demonstrating the acceptability, feasibility, and preliminary efficacy of this intervention approach.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50 rural adolescents experiencing elevated anxiety levels will be randomly assigned to the JITAI tool for a treatment period of 3 months or a waitlist control.
| Arm | Type | Receives |
|---|---|---|
| Just-In-Time Adaptive Intervention for Adolescent Anxiety | Experimental | Device: Just-In-Time Adaptive Intervention for Adolescent AnxietyParticipants in the Just-In-Time Adaptive Intervention for Adolescent Anxiety Arm will receive the just-in-time adaptive smartphone tool and be instructed to respond to the tool's prompts and follow delivered behavioral recommendations throughout the 3-month intervention period. |
| Waitlist Control | No intervention | –Participants in the Waitlist Control Arm will receive the just-in-time adaptive smartphone tool following the completion of the 3-month intervention period. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Adolescent (age 13-17 years old)
- New Hampshire resident
- Fluency in English
- Able to provide assent
- At least mild (≥5) anxiety based on the GAD-7 assessment
Key exclusion criteria (5 listed)
- Under 13 years old
- Over 17 years old
- Not a New Hampshire resident
- Unable to provide assent
- Less than mild (<5) anxiety based on the GAD-7 assessment
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 |
|---|---|---|
| Just-In-Time Adaptive Intervention for Adolescent AnxietyA JITAI smartphone app to reduce anxiety levels among rural adolescents by delivering somatic-based activity recommendations | Device | Just-In-Time Adaptive Intervention for Adolescent Anxiety |
Primary outcome
Change from Baseline in Symptoms of Generalized Anxiety at 3 Months
Time frame: Baseline and 3 months
Units on a scale measured through the GAD-7 (Generalized Anxiety Disorder-7) self-report questionnaire. Minimum score = 0, maximum score = 21, with a higher score indicating worse anxiety symptoms.
Change from Post-Treatment Symptoms of Generalized Anxiety to 1-month follow-up
Time frame: Post-Treatment (3 months after baseline) and 1-month follow-up (4 months after baseline)
Units on a scale measured through the GAD-7 (Generalized Anxiety Disorder-7) self-report questionnaire. Minimum score = 0, maximum score = 21, with a higher score indicating worse anxiety symptoms.
Change from Baseline in Interoceptive Awareness at 3 Months
Time frame: Baseline and 3 months
Units on a scale measured through the MAIA-Y (Multidimensional Assessment of Interoceptive Awareness for Youth) self-report questionnaire. Minimum score = 1, maximum score = 5, with higher scores indicating greater interoceptive awareness.
Change from Post-Treatment Interoceptive Awareness to 1-month follow-up
Time frame: Post-Treatment (3 months after baseline) and 1-month follow-up (4 months after baseline)
Units on a scale measured through the MAIA-Y (Multidimensional Assessment of Interoceptive Awareness for Youth) self-report questionnaire. Minimum score = 1, maximum score = 5, with higher scores indicating greater interoceptive awareness.
5 secondary outcomes
Pragmatic and Hedonic User Experience
Time frame: 3 months after baseline
Technology Engagement
Time frame: 3 months after baseline
User Engagement
Time frame: 3 months after baseline
Percentage of app-based intervention activities completed by participants
Time frame: Baseline through 3-month treatment period
Number of participants who complete the study
Time frame: End of treatment period (3 months after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Just-In-Time Adaptive Intervention for Adolescent Anxiety in people with Anxiety and Anxiety Disorders, run by Trustees of Dartmouth College.
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 5 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: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Murnane, PhD (603-646-0775, emurnane@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Symptoms of Generalized Anxiety at 3 Months (time frame: Baseline and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.