Clinical trial NCT06788119: Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders
Official title: Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders: a Randomized Controlled Trial Using a Mixed Methods Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Specific Phobia
Panic Disorder
Agoraphobia
Social Anxiety Disorder
Keywords: Anxiety disorders
In vivo exposure
app
smartphone
smartwatch
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Fear and avoidance scales
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Secondary outcomes:
measure: Severity Measure for Specific Phobia - Adult
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Acrophobia Questionnaire
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Claustrophoby Questionnaire
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Fear of Flying Questionnaire II
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Anxiety Sensitivity Inventory
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Fear Questionnaire (FQ)
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Social Interaction Anxiety Inventory (SIAS)
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Fear of negative evaluation scale
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Social avoidance and distress scale
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Panic Disorder Severity Scale (PDSS-SR)
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Agoraphobia Inventory
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Overall Depression Severity and Impairment Scale
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Overall Anxiety Severity and Impairment Scale
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Behavioral Avoidance Test
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Other outcomes:
measure: DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
timeFrame: Baseline, up to 12 weeks (average)
measure: The Clinician Severity Scale
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Item Short Form Health Survey (SF-12)
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Quality of Life Inventory
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: Patient's Improvement Scale (adapted from the Clinical Global Impression scale, CGI)
timeFrame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
measure: The Expectation of Treatment and Satisfaction with the Treatment scale (adapted from Borkovec and Nau)
timeFrame: Baseline, up to 12 weeks (average)
measure: Qualitative Interview
timeFrame: Up to 12 weeks (average)
measure: Preferences Questionnaire
timeFrame: Up to 12 weeks (average)
measure: The System Usability Scale (SUS)
timeFrame: Baseline, up to 12 weeks (average)
measure: User Version of the Mobile Application Rating Scale
timeFrame: Up to 12 weeks (average)
Locations:
city: Castellón de la plana
country: Spain
facility: University Jaume I
state: Castellón
Study officials:
affiliation: University Jaume I
name: Juana María Bretón-López, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: University Jaume I
name: Carlos Granell, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: University Jaume I
name: Sven Casteleyn, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plaisier I, Beekman AT, de Graaf R, Smit JH, van Dyck R, Penninx BW. Work functioning in persons with depressive and anxiety disorders: the role of specific psychopathological characteristics. J Affect Disord. 2010 Sep;125(1-3):198-206. doi: 10.1016/j.jad.2010.01.072. Epub 2010 Feb 24.
citation: Miralles I, Granell C, Diaz-Sanahuja L, Van Woensel W, Breton-Lopez J, Mira A, Castilla D, Casteleyn S. Smartphone Apps for the Treatment of Mental Disorders: Systematic Review. JMIR Mhealth Uhealth. 2020 Apr 2;8(4):e14897. doi: 10.2196/14897.
citation: Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015 Sep;17(3):327-35. doi: 10.31887/DCNS.2015.17.3/bbandelow.