RecruitingNot ApplicableNCT06788119

Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders

Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders: a Randomized Controlled Trial Using a Mixed Methods Approach

Sponsor

Universitat Jaume I

Enrollment

158 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Disorders Social Anxiety Disorder Specific Phobia Panic Disorder Agoraphobia

Summary

The aim of this study is to develop and test the efficacy of first-of-its-kind, fully instrumented sensor-based smartphone-guided in-vivo exposure therapy using a just-in-time intervention for anxiety disorder. The main hypotheses are: 1. Both treatment conditions (CBT treatment with IVE and CBT treatment with IVE+SYMPTOMS-JIT) will show efficacy and no statistically significant differences will be found between them. The efficacy will be determined for the differences in pre-post treatment in the used outcome measures. 2. The therapeutic gains obtained in both treatment conditions (IVE and (IVE+SYMPTOMS-JIT) will be maintained at 1-, 6-, and 12-month follow-up periods. 3. Both treatment conditions will be efficient, that is, they will be well-valued by patients and therapists. However, IVE+SYMPTOMS-JIT will be preferred and perceived as less aversive than IVE. 4. The main barriers for the use of this technology are not technological, but rather attitudinal and they can be identified through qualitative studies.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a mobile app called SYMPTOMS-JIT can improve the results of a standard treatment for anxiety disorders called exposure therapy — a technique where you gradually face the things you fear in a safe setting. The study aims to see if having real-time digital support helps people engage more effectively with the therapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with one of the following: specific phobia, agoraphobia (fear of open or crowded spaces), panic disorder, or social phobia (social anxiety disorder) - You are willing and able to follow the study conditions - You can sign a consent form **You may NOT be eligible if...** - You have another psychological condition that needs urgent treatment - You currently have alcohol or drug dependence, psychosis, or a severe brain-related illness - You are already enrolled in a similar treatment program - You are taking anti-anxiety medications during the study (or change your medication or dosage during the study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive behavioral therapy with in vivo exposure

CBT will be used as the chosen approach for ADs. The main components will be psychoeducation and to help patients to challenge and change unhelpful cognitive distortions (e.g., thoughts, beliefs, and attitudes) and behaviors (e.g., avoidance), develop emotion regulation strategies (e.g., cognitive reappraisal), and learn coping strategies that target problem-solving. The practice is developed in several sessions that usually last between 10 and 20 sessions. Specifically, the exposure component will be considered as the first-line treatment. During the exposure component, patients will confront themselves over a long period of time, repetitively, with a feared stimulus until distress has decreased significantly by the exposure.In this condition participants will receive CBT treatment and be exposed to in vivo situations.

BEHAVIORALCognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT

CBT will be used as the chosen approach for ADs. The main components will be psychoeducation and to help patients to challenge and change unhelpful cognitive distortions (e.g., thoughts, beliefs, and attitudes) and behaviors (e.g., avoidance), develop emotion regulation strategies (e.g., cognitive reappraisal), and learn coping strategies that target problem-solving. The practice is developed in several sessions that usually last between 10 and 20 sessions. Specifically, the exposure component will be considered as the first-line treatment. During the exposure component, patients will confront themselves over a long period of time, repetitively, with a feared stimulus until distress has decreased significantly by the exposure. In this condition participants will receive CBT treatment and be exposed to in vivo situations with the support of SYMPTOMS-JIT.

Locations(1)

University Jaume I

Castellon, Castellón, Spain

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NCT06788119

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