Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders
NCT ID: NCT06788119
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
158 participants
INTERVENTIONAL
2025-04-30
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CBT Treatment with in vivo exposure
In this condition participants will receive CBT treatment and be exposed to in vivo situations.
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.
CBT Treatment with in vivo exposure plus SYMPTOMS-JIT
In this condition participants will receive CBT treatment and be exposed to in vivo situations with the support of SYMPTOMS-JIT.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Universitat Jaume I
OTHER
Responsible Party
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Principal Investigators
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Juana María Bretón-López, Lecturer
Role: PRINCIPAL_INVESTIGATOR
University Jaume I
Carlos Granell, Lecturer
Role: PRINCIPAL_INVESTIGATOR
University Jaume I
Sven Casteleyn, Lecturer
Role: PRINCIPAL_INVESTIGATOR
University Jaume I
Locations
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University Jaume I
Castellon, Castellón, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Related Links
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Related Info
Other Identifiers
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UJaumeI_Symptoms_1
Identifier Type: -
Identifier Source: org_study_id
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