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NCT Number: NCT06946823

Implementation of a Just-In-Time Adaptive Intervention for Adolescent Anxiety

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)

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Key information

Conditions

Anxiety Anxiety Disorder of Childhood Anxiety Disorders Mental Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Just-In-Time Adaptive Intervention for Adolescent Anxiety

Device

A JITAI smartphone app to reduce anxiety levels among rural adolescents by delivering somatic-based activity recommendations

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Pragmatic and Hedonic User Experience

    Time frame: 3 months after baseline

    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.

  2. Technology Engagement

    Time frame: 3 months after baseline

    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.

  3. User Engagement

    Time frame: 3 months after baseline

    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.

  4. Percentage of app-based intervention activities completed by participants

    Time frame: Baseline through 3-month treatment period

    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.

  5. Number of participants who complete the study

    Time frame: End of treatment period (3 months after baseline)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Murnane, PhD

CONTACT

[email protected]

603-646-0775

Sponsors and collaborators

Lead sponsor

Trustees of Dartmouth College

Other

Registry information

Official study title

Community-Engaged Design and Implementation of a Just-In-Time Adaptive Intervention (JITAI) to Improve Adolescent Anxiety in Rural Populations

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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