Facing Fears From Home: Development, Feasibility and Maximization of FobiApp (FobiApp)
2026年9月7日 更新者：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).
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Soledad Quero, Ph.D
- 電話番号：+34 964 38 76 41
- メール：squero@uji.es
研究連絡先のバックアップ
- 名前：Lucía V Gómez-Fernández, Master's degree
- 電話番号：+34 644329743
- メール：al404316@uji.es
研究場所
-
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Valencia
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Castellon、Valencia、スペイン、12006
- Universitat Jaume I
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コンタクト：
- Soledad Quero, Ph.D
- 電話番号：+34 964 38 76 41
- メール：squero@uji.es
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).
時間枠：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
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991).
時間枠：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).
時間枠：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.
時間枠：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).
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diagnostic interview for SP in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia.
時間枠：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).
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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
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Soledad Quero, Ph.D、Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
- スタディディレクター：Almudena Duque, Ph.D、School of Psychology, Pontifical University of Salamanca, Spain.
- スタディチェア：Lucía V Gómez-Fernández, Master's degree、Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2028年2月28日
研究の完了 (推定)
2028年8月31日
試験登録日
最初に提出
2026年7月23日
QC基準を満たした最初の提出物
2026年9月7日
最初の投稿 (実際)
2026年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- Ujaume I_FobiApp
- CIAICO/2024/66 (その他の助成金/資金番号：Generalitat Valenciana)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Data will be available upon reasonable request after publication of the main study results.
IPD 共有アクセス基準
Access to de-identified data may be granted upon reasonable request for the purpose of verifying, reproducing, or further evaluating published findings.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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