Facing Fears From Home: Development, Feasibility and Maximization of FobiApp (FobiApp)
7 settembre 2026 aggiornato da: Universitat Jaume I
Facing Fears From Home. Development, Feasibility and Maximization of an App for Self-applied Exposure Treatment of Small Animal Phobia (FobiApp)
The aim of this study is to evaluate the feasibility (including usability, acceptance and satisfaction) and preliminary effectiveness of a smartphone App for self-administered exposure therapy using Augmented reality for cockroach phobia (FobiApp), compared to the same self-administered exposure therapy combined with training in attentional bias modification (ABM).
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Specific phobia (SP) is an intense and disproportionate fear or anxiety response toward a specific object or situation, which is actively avoided or confronted with significant distress. The prevalence of specific phobias is high, with annual prevalence estimates ranging from 3% to 15%. Despite this, only a small proportion of affected individuals seek or receive psychological treatment.
Currently, the treatment of choice for specific phobias is exposure to the feared stimulus, which involves systematic and gradual confrontation to reduce fear responses. In vivo exposure therapy, which consists of direct confrontation with the feared stimulus in real-life situations, has the strongest empirical support, although it has certain limitations. Although exposure therapy is the gold-standard treatment, barriers such as patient reluctance and logistical constraints limit its dissemination. Technological advances, including augmented reality-based exposure and attentional bias modification, have emerged as promising approaches to increase accessibility and effectiveness of interventions.
This study will be conducted following the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement for pilot and feasibility studies, the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and online
TeleHealth guidelines, and the Standard Protocol Items:
Recommendations for Interventional Trials (SPIRIT) guidelines.
Specific objectives of the study include: (1) To analyse the feasibility of different recruitment and data collection methods (e.g., how broad or restrictive are the eligibility criteria, how willing are patients to participate, time needed to collect data), (2) To explore reasons for non-participation and drop-outs from treatment, (3) To assess patient satisfaction and acceptance of treatment (both quantitatively and qualitatively), (4) In addition, as a secondary objective to explore the potential effectiveness of the treatment at post-treatment and treatment at post-treatment and follow- up. A total of 40 participants will be included in the feasibility trial, with 20 participants per group.
Data will be analyzed using descriptive statistics to summarize sociodemographic and clinical characteristics, as well as feasibility outcomes including recruitment, adherence, and dropout rates. Normality assumptions will be assessed prior to analysis. Feasibility indicators will be expressed as percentages with confidence intervals. Preliminary efficacy outcomes will be explored using within-group (pre-post and follow-up) and between-group comparisons, and effect sizes will be calculated. Quantitative analyses will be performed using IBM SPSS Statistics. Qualitative data will be analyzed using thematic analysis to identify themes related to acceptability and user experience.
Tipo di studio
Interventistico
Iscrizione (Stimato)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Soledad Quero, Ph.D
- Numero di telefono: +34 964 38 76 41
- Email: squero@uji.es
Backup dei contatti dello studio
- Nome: Lucía V Gómez-Fernández, Master's degree
- Numero di telefono: +34 644329743
- Email: al404316@uji.es
Luoghi di studio
-
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Valencia
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Castellon, Valencia, Spagna, 12006
- Universitat Jaume I
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Contatto:
- Soledad Quero, Ph.D
- Numero di telefono: +34 964 38 76 41
- Email: squero@uji.es
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Age ≥ 18 years
- Meeting diagnostic criteria for Specific Phobia (animal subtype: cockroaches) based on DSM-5-TR diagnostic criteria.
- Have had the phobia for at least one year.
- Having a score of at least 4 on the fear and avoidance scales of the administered diagnostic interview.
- Sign an informed consent.
- Having a smartphone and access to the Internet.
- Having an e-mail address.
Exclusion Criteria:
- Presence of another psychological problem that requires immediate attention
- Having current dependence or abuse of alcohol or drugs, psychosis or serious organic disease.
- Being currently treated in a similar treatment program.
- Being able to put his/her hands into a plastic container with a cockroach (during the behavioral test).
- Taking anxiolytics during the study (or if taking them, changing the drug or dose during the study).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: FobiApp with self-administered AR exposure therapy alone.
Participants receive the standard intervention consisting solely of the self-administered AR exposure therapy module via FobiaApp.
Compliance requires utilizing the app for 30 minutes per session, 3 times per week for 2 weeks period.
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The intervention will be delivered through a mobile application (FobiApp) that offers AR self-exposure therapy and ABM training for cockroach phobia.
The AR Exposure Module consists of progressively increasing levels of difficulty and intensity, controlled by predefined variables (number of cockroaches, location, and required behavior).
These levels are interspersed with psychoeducation (addressing fear, anxiety, and the justification for exposure) and educational information to debunk catastrophic beliefs.
Participants are instructed to use the AR module for two weeks, at least three times per week, for 30 minutes per session.
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Comparatore attivo: FobiApp with AR exposure therapy combined with ABM.
Participants first complete the augmented reality exposure therapy module following the same protocol (30 minutes per session, 3 times per week for 2 weeks).
Following this, for an additional two weeks, participants complete the ABM training module.
This module requires participants to complete progressive levels of ABM that involve, on the one hand, changes aimed at reducing the initial rapid detection of cockroaches (hypervigilance bias) and, on the other hand, prolonged visual focus on cockroaches to produce changes aimed at reducing avoidance behavior (avoidance bias) and thus address and modify attentional biases related to the phobia (hypervigilance-avoidance attentional biases).
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The ABM Module (administered once participants in Arm 2 have completed the exposure module) presents different levels that require specific behaviors, such as directing initial attention to a positive stimulus instead of the cockroach and maintaining visual attention on the cockroaches for an extended period.
This training aims to systematically modify hypervigilance and sustained attentional biases inherent in cockroach phobia.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).
Lasso di tempo: Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
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Participants' expectations and Satisfaction about the intervention will be assessed before the start of the treatment using the Expectations and Satisfaction Scales adapted from Borkovec and Nau (1972).
This questionnaire consists of two different scales.
Both include 6 items rated from 1 ("Not at all") to 10 ("Highly"), and provide information on the degree to which: 1) the treatment is perceived as logical; 2) patients are satisfied 3) would recommend the treatment to a friend with the same problem; 4) the treatment would be useful for treating other psychological problems; 5) patients perceive the treatment as useful for their specific problem; and 6) the treatment is perceived as aversive.
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Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
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Quantitative and qualitative opinion measure
Lasso di tempo: immediately after the intervention (post-treatment)
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Participants' satisfaction and opinions about the intervention A semi-structured opinion interview including both quantitative and qualitative questions will be administered, adapted from a previous feasibility study conducted by the research group (Mor et al., 2022).
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immediately after the intervention (post-treatment)
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Total score obtained in System Usability Scale (SUS)
Lasso di tempo: immediately after the intervention (post-treatment)
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Users respond to 10 statements using a 5-point Likert scale (where 1 = strongly disagree and 5 = strongly agree, offering a final score from 0 to 100.
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immediately after the intervention (post-treatment)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991).
Lasso di tempo: Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
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Behavioral avoidance will be assessed using a Behavioral Avoidance Test (BAT), adapted from Öst, Salkovskis, and Hellström (1991), which measures participants' ability to approach cockroach-related stimuli during a structured behavioral task.
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Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
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Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski &; O'Donohue, 1995).
Lasso di tempo: Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
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Fear of cockroaches will be assessed using the Fear of Spiders Questionnaire adapted for cockroach phobia (FSQ; adapted from Szymanski & O'Donohue, 1995).
This self-report questionnaire measures the intensity of fear associated with cockroach-related situations.
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Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
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Change in attentional biases.
Lasso di tempo: Baseline (pre-treatment), after the intervention (post- treatment), and 6 months after the intervention
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Attentional bias will be measured using an eye-tracking task designed to assess visual attention patterns (hypervigilance and sustained attention) toward cockroach-related stimuli.
Specifically, this task assessesthe attentional biases in terms of total time spent in looking at cockroaches, first fixation direction and the number and duration of fixations.
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Baseline (pre-treatment), after the intervention (post- treatment), and 6 months after the intervention
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Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979).
Lasso di tempo: Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.
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Patient improvement will be assessed using The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994).
which rates overall clinical change following the intervention assessed by the clinician.
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Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Diagnostic interview for SP in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia.
Lasso di tempo: Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention
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Assessed using the Phobia Section of the Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV; Di Nardo, Brown & Barlow, 1994).
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Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention
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Pretreatment levels of Depressive Symptoms
Lasso di tempo: Baseline (pre-treatment)
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Depressive symptoms will be measured using the Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996), a widely used self-report measure assessing the severity of depressive symptoms.
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Baseline (pre-treatment)
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Change in Disgust Propensity and Sensitivity Scale-Revised-12 (DPSS-R-12; Sandín et al., 2008)
Lasso di tempo: Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.
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This questionnaire includes two subscales that measure propensity to disgust and sensitivity to disgust.
It contains 12 items ranged from 1 (never) to 5 (always).
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Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.
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Pretreatment levels of State-Trait Anxiety Inventory (adapted from Laux, Glanzmann, Schaffner & Spielberger, 1981)
Lasso di tempo: Baseline (pre-treatment).
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This instrument includes two scales designed to assess state and trait anxiety respectively.
Each scale contains 20 items ranged from 0 (nothing/rarely) to 3 (very much/always).
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Baseline (pre-treatment).
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Soledad Quero, Ph.D, Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
- Direttore dello studio: Almudena Duque, Ph.D, School of Psychology, Pontifical University of Salamanca, Spain.
- Cattedra di studio: Lucía V Gómez-Fernández, Master's degree, Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Bar-Haim Y, Lamy D, Pergamin L, Bakermans-Kranenburg MJ, van IJzendoorn MH. Threat-related attentional bias in anxious and nonanxious individuals: a meta-analytic study. Psychol Bull. 2007 Jan;133(1):1-24. doi: 10.1037/0033-2909.133.1.1.
- First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available.
- Carl E, Stein AT, Levihn-Coon A, Pogue JR, Rothbaum B, Emmelkamp P, Asmundson GJG, Carlbring P, Powers MB. Virtual reality exposure therapy for anxiety and related disorders: A meta-analysis of randomized controlled trials. J Anxiety Disord. 2019 Jan;61:27-36. doi: 10.1016/j.janxdis.2018.08.003. Epub 2018 Aug 10.
- Mogoase C, David D, Koster EH. Clinical efficacy of attentional bias modification procedures: an updated meta-analysis. J Clin Psychol. 2014 Dec;70(12):1133-57. doi: 10.1002/jclp.22081. Epub 2014 Mar 20.
- Wechsler TF, Kumpers F, Muhlberger A. Inferiority or Even Superiority of Virtual Reality Exposure Therapy in Phobias?-A Systematic Review and Quantitative Meta-Analysis on Randomized Controlled Trials Specifically Comparing the Efficacy of Virtual Reality Exposure to Gold Standard in vivo Exposure in Agoraphobia, Specific Phobia, and Social Phobia. Front Psychol. 2019 Sep 10;10:1758. doi: 10.3389/fpsyg.2019.01758. eCollection 2019.
- Garcia-Palacios A, Botella C, Hoffman H, Fabregat S. Comparing acceptance and refusal rates of virtual reality exposure vs. in vivo exposure by patients with specific phobias. Cyberpsychol Behav. 2007 Oct;10(5):722-4. doi: 10.1089/cpb.2007.9962.
- Fodor LA, Georgescu R, Cuijpers P, Szamoskozi S, David D, Furukawa TA, Cristea IA. Efficacy of cognitive bias modification interventions in anxiety and depressive disorders: a systematic review and network meta-analysis. Lancet Psychiatry. 2020 Jun;7(6):506-514. doi: 10.1016/S2215-0366(20)30130-9. Epub 2020 May 20.
- Baus O, Bouchard S. Moving from virtual reality exposure-based therapy to augmented reality exposure-based therapy: a review. Front Hum Neurosci. 2014 Mar 4;8:112. doi: 10.3389/fnhum.2014.00112. eCollection 2014.
- Beard C. Cognitive bias modification for anxiety: current evidence and future directions. Expert Rev Neurother. 2011 Feb;11(2):299-311. doi: 10.1586/ern.10.194.
- Wardenaar KJ, Lim CCW, Al-Hamzawi AO, Alonso J, Andrade LH, Benjet C, Bunting B, de Girolamo G, Demyttenaere K, Florescu SE, Gureje O, Hisateru T, Hu C, Huang Y, Karam E, Kiejna A, Lepine JP, Navarro-Mateu F, Oakley Browne M, Piazza M, Posada-Villa J, Ten Have ML, Torres Y, Xavier M, Zarkov Z, Kessler RC, Scott KM, de Jonge P. The cross-national epidemiology of specific phobia in the World Mental Health Surveys. Psychol Med. 2017 Jul;47(10):1744-1760. doi: 10.1017/S0033291717000174. Epub 2017 Feb 22.
- Olatunji, B. O., Deacon, B. J., & Abramowitz, J. S. (2009). The Cruelest Cure? Ethical Issues in the Implementation of Exposure-Based Treatments. Cognitive and Behavioral Practice, 16(2), 172-180. https://doi.org/10.1016/j.cbpra.2008.07.003
- Nathan, P., & Gorman, J. (2015). A guide to treatments that work (P. Nathan & J. Gorman (eds.)). Oxford University Press.
- Kazdin, A. E., & Rabbitt, S. M. (2013). Novel Models for Delivering Mental Health Services and Reducing the Burdens of Mental Illness. Clinical Psychological Science, 1(2), 170-191. https://doi.org/10.1177/2167702612463566
- Grimaldos, J., Duque, A., Bretón-López, J., Díaz-Sanahuja, L. y Quero, S. (2024). Is everyone afraid of them? Attentional biases in cockroach phobia: Evidence from eye-tracking. Submitted to Journal of Behavior Therapy and Experimental Psychiatry.
- Fox E, Zougkou K, Ashwin C, Cahill S. Investigating the efficacy of attention bias modification in reducing high spider fear: The role of individual differences in initial bias. J Behav Ther Exp Psychiatry. 2015 Dec;49(Pt A):84-93. doi: 10.1016/j.jbtep.2015.05.001. Epub 2015 May 13.
- Eaton WW, Bienvenu OJ, Miloyan B. Specific phobias. Lancet Psychiatry. 2018 Aug;5(8):678-686. doi: 10.1016/S2215-0366(18)30169-X.
- Craske, M. G., Antony, M. M., & Barlow, D. H. (2006). Mastering your fears and phobias. Oxford University Press.
- Clauss K, Gorday JY, Bardeen JR. Eye tracking evidence of threat-related attentional bias in anxiety- and fear-related disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2022 Apr;93:102142. doi: 10.1016/j.cpr.2022.102142. Epub 2022 Mar 7.
- Botella, C., Baños, R. M., García-Palacios, A., & Quero, S. (2017). Virtual Reality and Other Realities. In The Science of Cognitive Behavioral Therapy (pp. 551-590). Elsevier. https://doi.org/10.1016/B978-0-12-803457- 6.00022-2
- Armstrong T, Hemminger A, Olatunji BO. Attentional bias in injection phobia: overt components, time course, and relation to behavior. Behav Res Ther. 2013 Jun;51(6):266-73. doi: 10.1016/j.brat.2013.02.008. Epub 2013 Mar 4.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
28 febbraio 2028
Completamento dello studio (Stimato)
31 agosto 2028
Date di iscrizione allo studio
Primo inviato
23 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
7 settembre 2026
Primo Inserito (Effettivo)
10 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Ujaume I_FobiApp
- CIAICO/2024/66 (Altro numero di sovvenzione/finanziamento: Generalitat Valenciana)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Only aggregated data will be shared.
If additional data are requested for scientific purposes or to support published findings, they will be provided in an anonymized form and in accordance with applicable ethical and data protection regulations.
Periodo di condivisione IPD
Data will be available upon reasonable request after publication of the main study results.
Criteri di accesso alla condivisione IPD
Access to de-identified data may be granted upon reasonable request for the purpose of verifying, reproducing, or further evaluating published findings.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .