NCT06788119

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Universitat Jaume I · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Anxiety Disorders are one of the most prevalent psychological problems around the world and if not treated they tend to become chronic. Cognitive Behavioral Therapy (CBT) is the treatment of choice, being the component of in vivo exposure (IVE) the central feature. Despite its efficacy it is still a hard component to implement for the patients. Information and Communication Technologies (ICT) can help assisting and/or applying psychological interventions. The proposed study will fill the existing gap in this sense as it will assess the efficacy of a fully configurable, sensor-guided and location-based (GPS) app for the in vivo exposure component. It will also address the shortage of clinical validation studies of mHealth apps thanks to the proposed RCT. The study will expand our knowledge about the use of technologies in mental health problems and help improve the effectiveness of exposure therapy.

Conditions

• Anxiety Disorders
• Specific Phobia
• Panic Disorder
• Agoraphobia
• Social Anxiety Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive 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.
BEHAVIORAL	Cognitive 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.

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-01-22
• Last updated: 2025-05-16

Locations

1 site across 1 country: Spain