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

7 września 2026 zaktualizowane przez: 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).

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Soledad Quero, Ph.D
  • Numer telefonu: +34 964 38 76 41
  • E-mail: squero@uji.es

Kopia zapasowa kontaktu do badania

  • Nazwa: Lucía V Gómez-Fernández, Master's degree
  • Numer telefonu: +34 644329743
  • E-mail: al404316@uji.es

Lokalizacje studiów

  • Hiszpania
    • Valencia
      • Castellon, Valencia, Hiszpania, 12006
        • Universitat Jaume I
        • Kontakt:
          • Soledad Quero, Ph.D
          • Numer telefonu: +34 964 38 76 41
          • E-mail: squero@uji.es

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny 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.
Behawioralne: 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.
Aktywny 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).
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991).
Ramy czasowe: 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).
Ramy czasowe: 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.
Ramy czasowe: 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).
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Diagnostic interview for SP in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia.
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Universitat Jaume I

Współpracownicy

Generalitat Valenciana

Śledczy

  • Główny śledczy: Soledad Quero, Ph.D, Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
  • Dyrektor Studium: Almudena Duque, Ph.D, School of Psychology, Pontifical University of Salamanca, Spain.
  • Krzesło do nauki: Lucía V Gómez-Fernández, Master's degree, Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

28 lutego 2028

Ukończenie studiów (Szacowany)

31 sierpnia 2028

Daty rejestracji na studia

Pierwszy przesłany

23 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 września 2026

Pierwszy wysłany (Rzeczywisty)

10 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Ujaume I_FobiApp
  • CIAICO/2024/66 (Inny numer grantu/finansowania: Generalitat Valenciana)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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