Anxiety DisordersNCT06788119
Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders
A study testing Cognitive behavioral therapy with in vivo exposure and Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT in people with Anxiety Disorders and Specific Phobia, run by Universitat Jaume I at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Specific Phobia, Panic Disorder
- What is being tested?
- Cognitive behavioral therapy with in vivo exposure and Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University Jaume I
Castellon, Castellón, 12071
Juana María Bretón-López, Lecturer, +34 964 38 76 42, breton@uji.es
Iratxe Alonso-Olea, Phd student, +34 964 38 76 51, iolea@uji.es
About this study
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
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:
- 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.
- 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.
- 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.
- The main barriers for the use of this technology are not technological, but rather attitudinal and they can be identified through qualitative studies.
Read the 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.
- Being tested
- Cognitive behavioral therapy with in vivo exposure, Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT
- Keywords
- Anxiety disorders, In vivo exposure, app, smartphone, smartwatch
- Medical subject headings
- Anxiety Disorders, Phobia, Specific, Panic Disorder, Agoraphobia, Phobia, Social, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy with in vivo exposureBehavioural
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-JITBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT Treatment with in vivo exposure | Active comparator | In this condition participants will receive CBT treatment and be exposed to in vivo situations. Receives: 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. Receives: Behavioral: Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 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")
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Secondary outcomes (14)
Severity Measure for Specific Phobia - Adult
The SMSP-A is a 10-item measure that assesses the severity of specific phobia in adults during the last 7 days. Each item is rated on a 5-point scale, from 0 (never) to 4 (all of the time). Greater scores indicate more severe specific phobia, being the overall score 40.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Acrophobia Questionnaire
The AQ evaluates severity of anxiety and avoidance related to different situations that have to do with heights. It consists of 40 items divided into two subscales. On the one hand, there is an anxiety subscale where it is necessary to indicate the degree of anxiety, tension, or discomfort caused in the situations described, responding on a 0 to 6 point Likert-type scale ("no anxiety, calm and relaxed" - "extremely anxious"); and on the other hand, there is an avoidance subscale, where the response is coded on a 0 to 2 point Likert-type scale ("I would not try to avoid it" - "I would not bear it under any circumstances")
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Claustrophoby Questionnaire
The CLQ consists of descriptions of 26 claustrophobic situations. Participants are asked about the degree to which they would feel anxious in these situations according to a 5-alternative Likert-type scale, where (0) is "not at all anxious" and (4) is "extremely anxious." The CLQ consists of two subscales: restriction of movement, ranging from items 1 to 12, and suffocation, ranging from items 13 to 26.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Fear of Flying Questionnaire II
This is a list of 30 situations related to flying that can cause discomfort or anxiety, divided into three subscales: in-flight situations, pre-flight situations, and vicarious situations. The items (each representing a situation) are rated on Likert scales from 1 (minimal discomfort) to 10 (maximum discomfort), and therefore the score ranges from 30 to 300.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Anxiety Sensitivity Inventory
The ASI is a scale composed of 16 items specifying a possible negative consequence to anxiety: additional anxiety or fear, illness, embarrassment and loss of control. The patient is required to rate each item in a 5-point scale, ranging from 0 (very little) to 4 (very much). The ASI has adequate test/retest reliability.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Fear Questionnaire (FQ)
The FQ is a 15-item questionnaire that yields four scores: main phobia, global phobia, total phobia and anxiety-depression; the total phobia score is composed of agoraphobia, social and blood-injury subgroups. It is reliable and valid.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Social Interaction Anxiety Inventory (SIAS)
The SIAS assesses fears of general social interaction. It comprises 20 items, rated on a 5-point Likert scale, from 0 (not at all characteristic of me) to 4 (extremely characteristic of me). Internal consistency and test-retest reliability is high.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Fear of negative evaluation scale
The FNE is a 30-item true-false inventory measuring anticipation of and distress about being negatively evaluated by others.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Social avoidance and distress scale
The SAD is a 28-item true-false questionnaire measuring subjective distress experienced in social situations and avoidance of such situations.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Panic Disorder Severity Scale (PDSS-SR)
The PDSS-SR is a self-report that consists of seven items rating frequency of panic attacks on a 5-point scale from 0 to 4, being the total score 28. It has good test-retest reliability and is sensitive to change with treatment.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Agoraphobia Inventory
This instrument measures the types of altered responses (motor (to places, means of transportation, and situations), subjective psychophysiological, and cognitive) of the patient, alone and in company, to the most common stimulus situations, as well as the variability of altered responses. Among the proposed items, patients must also indicate the symptoms that cause them the most difficulties in daily life.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Overall Depression Severity and Impairment Scale
The ODSIS is a five-item instrument designed to measure severity and impairment of depressive symptoms. Items are coded from 0 to 4 and are summed to obtain one total score.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Overall Anxiety Severity and Impairment Scale
The OASIS is a five-item continuous measure of anxiety-related severity and impairment. Items are coded from 0 to 4 and are summed to obtain one total score. The OASIS have shown high internal consistency, excellent test-retest reliability, and convergent and discriminant validity in clinical and non-clinical samples (i.e., Norman et al., 2006)
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Behavioral Avoidance Test
Behavioral Avoidance Tests (BATs) are fundamental tools in the assessment and treatment of specific anxiety disorders, such as claustrophobia, acrophobia, panic disorder, and social anxiety. For claustrophobia, a BAT may involve progressively entering confined spaces, such as an elevator or a windowless room, while recording their anxiety level and avoidance behavior. For acrophobia, a BAT could involve gradually climbing to elevated locations, such as stairs or balconies, allowing observation of how they tolerate exposure to height. For panic disorder, interoceptive BATs are used, in which feared physical sensations (such as hyperventilating or spinning in a chair) are induced to assess the patient's reaction to bodily symptoms associated with panic. On the other hand, in social anxiety, a common task in a BAT is to ask the patient to give a speech in front of a small audience or a camera, thereby assessing their level of discomfort, physiological arousal, and avoidance behaviors.
Measured: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start30 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juana María Bretón-López, Lecturer, Principal investigator, University Jaume ICarlos Granell, Lecturer, Principal investigator, University Jaume ISven Casteleyn, Lecturer, Principal investigator, University Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788119
- Sponsor's protocol ID
- UJaumeI_Symptoms_1
- Status last verified
- May 2025
- First submitted
- 19 Dec 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20185180Miralles 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.
PubMed 32238332Bandelow 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.
PubMed 26487813Alonso-Olea I, Gual-Montolio P, Diaz-Sanahuja L, Nino-Ruiz L, Mira A, Casteleyn S, Granell C, Garcia-Palacios A, Breton-Lopez J. Maximising the efficacy of in vivo exposure therapy using smartphone-assisted just-in-time adaptive intervention for anxiety disorders: study protocol for a randomised controlled trial. BMJ Open. 2026 Sep 22;16(9):e117124. doi: 10.1136/bmjopen-2026-117124.
PubMed 42772863
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06788119
- Acronym / sponsor ID
- UJaumeI_Symptoms_1
- Keywords
- Anxiety disorders, In vivo exposure, app, smartphone, smartwatch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT Treatment with in vivo exposure | Active comparator | Behavioral: Cognitive behavioral therapy with in vivo exposureIn this condition participants will receive CBT treatment and be exposed to in vivo situations. |
| CBT Treatment with in vivo exposure plus SYMPTOMS-JIT | Experimental | Behavioral: Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JITIn this condition participants will receive CBT treatment and be exposed to in vivo situations with the support of SYMPTOMS-JIT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapy with in vivo exposureCBT 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. | Behavioural | CBT Treatment with in vivo exposure |
| Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JITCBT 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. | Behavioural | CBT Treatment with in vivo exposure plus SYMPTOMS-JIT |
Primary outcome
Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
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")
Fear and avoidance scales
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
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")
14 secondary outcomes
Severity Measure for Specific Phobia - Adult
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Acrophobia Questionnaire
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Claustrophoby Questionnaire
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Fear of Flying Questionnaire II
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Anxiety Sensitivity Inventory
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Fear Questionnaire (FQ)
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Social Interaction Anxiety Inventory (SIAS)
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Fear of negative evaluation scale
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Social avoidance and distress scale
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Panic Disorder Severity Scale (PDSS-SR)
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Agoraphobia Inventory
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Overall Depression Severity and Impairment Scale
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Overall Anxiety Severity and Impairment Scale
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Behavioral Avoidance Test
Time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 20185180Plaisier 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.
- Background: PubMed 32238332Miralles 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.
- Background: PubMed 26487813Bandelow 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.
- Derived from this study: PubMed 42772863Alonso-Olea I, Gual-Montolio P, Diaz-Sanahuja L, Nino-Ruiz L, Mira A, Casteleyn S, Granell C, Garcia-Palacios A, Breton-Lopez J. Maximising the efficacy of in vivo exposure therapy using smartphone-assisted just-in-time adaptive intervention for anxiety disorders: study protocol for a randomised controlled trial. BMJ Open. 2026 Sep 22;16(9):e117124. doi: 10.1136/bmjopen-2026-117124.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juana María Bretón-López, Lecturer principal investigator
University Jaume I
Carlos Granell, Lecturer principal investigator
University Jaume I
Sven Casteleyn, Lecturer principal investigator
University Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy with in vivo exposure and Cognitive behavorial therapy with in vivo exposure plus SYMPTOMS-JIT in people with Anxiety Disorders and Specific Phobia, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iratxe Alonso-Olea, Phd Student (+34 964 38 76 51, iolea@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) (time frame: Baseline, up to 12 weeks (average), follow-ups (3 months, 6 months, 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788119, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.