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

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).

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.

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).