Cognitive-behavioural therapy (CBT) is the preferred treatment for anxiety disorders, and in vivo exposure (IVE) is a core therapeutic element. IVE requires patients to confront feared stimuli and situations progressively to foster habituation. Although effective, IVE is challenging for many patients to perform independently and typically requires considerable therapist time and resources to support and supervise exposures. Smartphones offer new opportunities to complement psychological treatments and to deliver adaptive, context-sensitive support.
This trial protocol describes a randomized controlled study to evaluate whether an app, SyMptOMS-ET, can enhance the delivery and efficacy of IVE by providing a just-in-time, momentary ecological intervention that monitors the patient’s state and context and delivers tailored guidance during exposure tasks. The primary objective is to determine whether CBT with IVE supported by SyMptOMS-ET improves fear and interference outcomes compared with CBT with traditional IVE.
The study is a randomized controlled trial with two parallel arms. A total of 158 adult participants meeting criteria for DSM-5 anxiety disorders will be randomized equally (1:1) into two groups:
Both arms receive CBT with IVE as the exposure modality; the distinguishing feature is the provision of the smartphone-based, just-in-time adaptive support in the experimental arm. Allocation details beyond randomization ratio were not reported in the source.
Participants are adult volunteers diagnosed with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) anxiety disorders. Included diagnostic categories specified in the protocol are specific phobia, agoraphobia, panic disorder, and social anxiety disorder.
Diagnostic assessment will use the Diagnostic Interview for DSM, Fourth Edition, Text Revision (DSM-IV-TR) anxiety disorder modules as the diagnostic measure. The source did not report additional inclusion or exclusion criteria, recruitment methods, or specific demographic targets.
The SyMptOMS-ET app is designed to provide a just-in-time momentary ecological intervention leveraging advanced smartphone features. According to the protocol description, the app will:
The source describes the app conceptually but does not report technical specifications, exact monitoring modalities, algorithms for determining intervention timing, user interface details, or implementation procedures within therapy sessions.
Primary outcomes will be assessed using the interference and fear scales from the Anxiety Disorders Interview Schedule for DSM-IV and with individualized target behaviours (presumably tied to each participant’s exposure goals). Secondary outcomes will evaluate acceptability, patient satisfaction, usability and app quality.
Assessments are scheduled at the following time points:
The source indicates both per-protocol and intention-to-treat analyses will be performed. Specific measurement instruments for acceptability, satisfaction, usability, or app quality were not detailed in the provided text.
Data will be analyzed both per-protocol and by intention-to-treat to evaluate the efficacy of the SyMptOMS-ET-supported IVE versus traditional IVE. The protocol description in the source did not provide further details on sample size calculations, statistical models, handling of missing data, adjustment for covariates, or planned subgroup analyses.
The study received ethical approval from the Universitat Jaume I Ethics Committee (Castellón, Spain), reference CEISH/51/2024. The trial is registered under number NCT06788119.
Investigators plan active dissemination of results through manuscript publications and presentations at national and international conferences. The source did not report timelines for data collection, planned publication venues, or other dissemination specifics.
Overall, this protocol outlines a randomized comparison of standard CBT plus traditional IVE versus CBT with smartphone-assisted, just-in-time support for IVE using SyMptOMS-ET among adults with DSM-5 anxiety disorders. The trial’s design, outcome schedule and primary measures are described, while several implementation and analytic details were not reported in the provided source text.