Specific Phobia
Conditions
Keywords
Attention Bias Modification, Augmented Reality, Cockroach Phobia, Cognitive Bias Modification, Exposure Therapy, Mobile Application, Animal Phobia
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALFobiApp 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.
BEHAVIORALFobiApp 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.
Sponsors
Universitat Jaume I
Generalitat Valenciana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants and investigators are aware of the intervention assigned through the mobile application.
Intervention model description
Participants will be assessed for eligibility and if they meet the inclusion criteria, they will be randomly assigned to one of two parallel groups (FobiApp with self-administered AR exposure therapy or FobiApp with self-administered AR exposure combined with ABM). The allocation schedule will be generated through an independent researcher who will be unaware of the characteristics of the study. Patients will agree to participate before the random allocation and without knowing to which treatment they will be assigned.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972). | 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. |
| Quantitative and qualitative opinion measure | 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). |
| Total score obtained in System Usability Scale (SUS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991). | 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. |
| Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski &; O'Donohue, 1995). | 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. |
| Change in attentional biases. | 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. |
| Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979). | 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. |
Countries
Spain
Contacts
CONTACTSoledad Quero, Ph.D
CONTACTLucía V Gómez-Fernández, Master's degree
PRINCIPAL_INVESTIGATORSoledad Quero, Ph.D
Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
STUDY_DIRECTORAlmudena Duque, Ph.D
School of Psychology, Pontifical University of Salamanca, Spain.
STUDY_CHAIRLucía V Gómez-Fernández, Master's degree
Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón, Spain
Outcome results
None listed