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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Jaume I

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • FobiApp AR Exposure therapy, Self-administered augmented reality exposure for cockroach phobia

    Behavioral

    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.

  • FobiApp AR Exposure therapy + ABM, Self- administered augmented reality exposure combined with attentional bias modification training for cockroach phobia.

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: FobiApp with self-administered AR exposure therapy alone.Active comparator 1 intervention
Group B: FobiApp with AR exposure therapy combined with ABM.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Expectations and Satisfaction Questionnaire adapted from Borkovec and Nau (1972).

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.

Time frame
Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
2

Quantitative and qualitative opinion measure

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).

Time frame
immediately after the intervention (post-treatment)
3

Total score obtained in System Usability Scale (SUS)

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.

Time frame
immediately after the intervention (post-treatment)

Secondary outcomes

1

Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991).

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.

Time frame
Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
2

Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski &; O'Donohue, 1995).

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.

Time frame
Baseline (pre-treatment), immediately after the intervention (post-treatment) and follow-up 6 months after the intervention
3

Change in attentional biases.

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.

Time frame
Baseline (pre-treatment), after the intervention (post- treatment), and 6 months after the intervention
4

Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979).

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.

Time frame
Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.

Other outcomes

1

Diagnostic interview for SP in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia.

Assessed using the Phobia Section of the Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV; Di Nardo, Brown \& Barlow, 1994).

Time frame
Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention
2

Pretreatment levels of Depressive Symptoms

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.

Time frame
Baseline (pre-treatment)
3

Change in Disgust Propensity and Sensitivity Scale-Revised-12 (DPSS-R-12; Sandín et al., 2008)

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).

Time frame
Baseline (pre-treatment), after the intervention (post-treatment), and follow-up 6 months after the intervention.
4

Pretreatment levels of State-Trait Anxiety Inventory (adapted from Laux, Glanzmann, Schaffner & Spielberger, 1981)

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).

Time frame
Baseline (pre-treatment).

Sponsors and contacts

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Universitat Jaume I

Lead sponsor

Generalitat Valenciana

Collaborator

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