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Facing Fears From Home: Development, Feasibility and Maximization of FobiApp (FobiApp)

7. September 2026 aktualisiert von: 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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Soledad Quero, Ph.D
  • Telefonnummer: +34 964 38 76 41
  • E-Mail: squero@uji.es

Studieren Sie die Kontaktsicherung

  • Name: Lucía V Gómez-Fernández, Master's degree
  • Telefonnummer: +34 644329743
  • E-Mail: al404316@uji.es

Studienorte

  • Spanien
    • Valencia
      • Castellon, Valencia, Spanien, 12006
        • Universitat Jaume I
        • Kontakt:
          • Soledad Quero, Ph.D
          • Telefonnummer: +34 964 38 76 41
          • E-Mail: squero@uji.es

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Verhalten: FobiApp AR Exposure therapy, Self-administered augmented reality exposure for cockroach phobia
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.
Aktiver Komparator: 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).
Verhalten: FobiApp AR Exposure therapy + ABM, Self- administered augmented reality exposure combined with attentional bias modification training for cockroach phobia.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).
Zeitfenster: Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
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.
Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
Quantitative and qualitative opinion measure
Zeitfenster: immediately after the intervention (post-treatment)
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).
immediately after the intervention (post-treatment)
Total score obtained in System Usability Scale (SUS)
Zeitfenster: immediately after the intervention (post-treatment)
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.
immediately after the intervention (post-treatment)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991).
Zeitfenster: Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
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.
Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski &; O'Donohue, 1995).
Zeitfenster: Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
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.
Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
Change in attentional biases.
Zeitfenster: Baseline (pre-treatment), after the intervention (post- treatment), and 6 months after the intervention
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.
Baseline (pre-treatment), after the intervention (post- treatment), and 6 months after the intervention
Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979).
Zeitfenster: Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.
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.
Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Diagnostic interview for SP in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia.
Zeitfenster: Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention
Assessed using the Phobia Section of the Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV; Di Nardo, Brown & Barlow, 1994).
Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention
Pretreatment levels of Depressive Symptoms
Zeitfenster: Baseline (pre-treatment)
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.
Baseline (pre-treatment)
Change in Disgust Propensity and Sensitivity Scale-Revised-12 (DPSS-R-12; Sandín et al., 2008)
Zeitfenster: Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.
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).
Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.
Pretreatment levels of State-Trait Anxiety Inventory (adapted from Laux, Glanzmann, Schaffner & Spielberger, 1981)
Zeitfenster: Baseline (pre-treatment).
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).
Baseline (pre-treatment).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universitat Jaume I

Mitarbeiter

Generalitat Valenciana

Ermittler

  • Hauptermittler: Soledad Quero, Ph.D, Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
  • Studienleiter: Almudena Duque, Ph.D, School of Psychology, Pontifical University of Salamanca, Spain.
  • Studienstuhl: Lucía V Gómez-Fernández, Master's degree, Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

28. Februar 2028

Studienabschluss (Geschätzt)

31. August 2028

Studienanmeldedaten

Zuerst eingereicht

23. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. September 2026

Zuerst gepostet (Tatsächlich)

10. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Ujaume I_FobiApp
  • CIAICO/2024/66 (Andere Zuschuss-/Finanzierungsnummer: Generalitat Valenciana)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

Data will be available upon reasonable request after publication of the main study results.

IPD-Sharing-Zugriffskriterien

Access to de-identified data may be granted upon reasonable request for the purpose of verifying, reproducing, or further evaluating published findings.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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