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

Universitat Jaume I

Status: Enrolling

Conditions: Panic Disorder; Specific Phobia; Social Anxiety Disorder; Agoraphobia; Anxiety Disorders

Treatments: Behavioral: Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT; Behavioral: Cognitive behavioral therapy with in vivo exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT06788119

UJaumeI_Symptoms_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being at least 18 years or older.
• Meeting DSM-5 diagnostic criteria (APA, 2013) for anxiety disorder, specifically specific phobia, agoraphobia, panic disorder and social phobia.
• Being willing to follow the study conditions.
• Sign the consent form.

Exclusion criteria

• Having another psychological problem that requires immediate attention.
• Having current alcohol or drug dependence or abuse, psychosis or severe organic illness.
• Currently being treated in a similar treatment program.
• Taking anxiolytics during the study (or in the case of taking them, changing drug or dose during the study).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

158 participants in 2 patient groups

CBT Treatment with in vivo exposure

Active Comparator group

Description:

In this condition participants will receive CBT treatment and be exposed to in vivo situations.

Treatment:

Behavioral: Cognitive behavioral therapy with in vivo exposure

CBT Treatment with in vivo exposure plus SYMPTOMS-JIT

Experimental group

Description:

In this condition participants will receive CBT treatment and be exposed to in vivo situations with the support of SYMPTOMS-JIT.

Treatment:

Behavioral: Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT