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

NCT06788119 | Recruiting DMC

• 1 other identifier: UJaumeI_Symptoms_1
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 4.The main barriers for the use of this technology are not technological, but rather attitudinal and they can be identified through qualitative studies.

Conditions

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

Keywords

Anxiety disorders; In vivo exposure; app; smartphone; smartwatch

Outcome Measures

Primary Outcomes (2)

• Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)

  It is a specific diagnostic semistructured interview for the diagnosis of anxiety disorders. Phobias, Agoraphobia and Social Phobia Sections will be used. For the majority of anxiety disorders, this interview has demonstrated appropriate psychometric qualities and good to exceptional reliability (Orsillo \& Roemer, 2001). This instrument includes relevant clinical measures such as interference and distress as perceived by the participant on a scale from 0 to 8 (wherein 0 = "Not at all" and 8 = "Very severe")

  Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

• Fear and avoidance scales

  The participants and therapists identify the situations and physical sensations that cause the participants the most fear and distress, as well as the negative thoughts associated with them. Next, they assess, on a scale of 0-10, the degree of fear (0="no fear"; 10="extreme fear") and avoidance (0="never avoid"; 10="always avoid") for each feared situation and sensation. In addition, the degree of belief in the negative thoughts related with the target behaviors and sensations are also assessed, using a scale ranging from 0 ("I do not believe the content of the thought at all") to 10 ("I believe the thought is totally true")

  Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

Secondary Outcomes (14)

• Severity Measure for Specific Phobia - Adult

  Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

• Acrophobia Questionnaire

  Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

• Claustrophoby Questionnaire

  Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

• Fear of Flying Questionnaire II

  Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

• Anxiety Sensitivity Inventory

  Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

Other Outcomes (10)

• DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)

  Baseline, up to 12 weeks (average)

• The Clinician Severity Scale

  Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

• Item Short Form Health Survey (SF-12)

  Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)

Study Arms (2)

CBT Treatment with in vivo exposure

ACTIVE COMPARATOR

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

Behavioral: Cognitive behavioral therapy with in vivo exposure

CBT Treatment with in vivo exposure plus SYMPTOMS-JIT

EXPERIMENTAL

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

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

Interventions

Cognitive behavioral therapy with in vivo exposure BEHAVIORAL

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

Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT BEHAVIORAL

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.

CBT Treatment with in vivo exposure plus SYMPTOMS-JIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

University Jaume I

Castellon, Castellón, 12071, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 20185180 BACKGROUND

• 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.

  PMID: 32238332 BACKGROUND

• 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.

  PMID: 26487813 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Specific; Panic Disorder; Agoraphobia; Phobia, Social; Alzheimer Disease

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Juana María Bretón-López, Lecturer

  University Jaume I

  PRINCIPAL INVESTIGATOR

• Carlos Granell, Lecturer

  University Jaume I

  PRINCIPAL INVESTIGATOR

• Sven Casteleyn, Lecturer

  University Jaume I

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iratxe Alonso-Olea, Phd Student

CONTACT

+34 964 38 76 51; iolea@uji.es

Juana María Bretón-López, Lecturer

CONTACT

+34 964 38 76 42; breton@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 22, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

ES (1)