Facing Fears From Home: Development, Feasibility and Maximization of FobiApp (FobiApp)
7 de septiembre de 2026 actualizado por: 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).
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Soledad Quero, Ph.D
- Número de teléfono: +34 964 38 76 41
- Correo electrónico: squero@uji.es
Copia de seguridad de contactos de estudio
- Nombre: Lucía V Gómez-Fernández, Master's degree
- Número de teléfono: +34 644329743
- Correo electrónico: al404316@uji.es
Ubicaciones de estudio
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Valencia
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Castellon, Valencia, España, 12006
- Universitat Jaume I
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Contacto:
- Soledad Quero, Ph.D
- Número de teléfono: +34 964 38 76 41
- Correo electrónico: squero@uji.es
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991).
Periodo de tiempo: 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).
Periodo de tiempo: 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.
Periodo de tiempo: 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).
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic interview for SP in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia.
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Soledad Quero, Ph.D, Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
- Director de estudio: Almudena Duque, Ph.D, School of Psychology, Pontifical University of Salamanca, Spain.
- Silla de estudio: Lucía V Gómez-Fernández, Master's degree, Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
28 de febrero de 2028
Finalización del estudio (Estimado)
31 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
23 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de septiembre de 2026
Publicado por primera vez (Actual)
10 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Ujaume I_FobiApp
- CIAICO/2024/66 (Otro número de subvención/financiamiento: Generalitat Valenciana)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Data will be available upon reasonable request after publication of the main study results.
Criterios de acceso compartido de IPD
Access to de-identified data may be granted upon reasonable request for the purpose of verifying, reproducing, or further evaluating published findings.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .