Improving the Efficacy of Exposure Therapy for the Treatment of Cockroach Phobia

NCT04563403 | Recruiting DMC

• 1 other identifier: TERA-P MS SS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to test the efficacy and efficiency of the Projection-Based augmented reality therapy under two conditions: multiple stimuli (different types of cockroaches) (P-ARET MS) versus single stimulus (one cockroach) (P-ARET SS) for the treatment of participants diagnosed with cockroach phobia.

Conditions

Specific Phobia, Animal

Keywords

Specific Phobia; Cockroach phobia; Exposure therapy; Projection-Based augmented reality therapy; Multiple Stimuli; Single Stimulus; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

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

  Patients will be confronted to a real cockroach and they will be encouraged to get closer and interact with the stimulus as much as they can. The anxiety level (0-10), distance and level of interaction with the animal will be registered and evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (the participant interacts with the cockroach).

  Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.

Secondary Outcomes (7)

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

  Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.

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

  Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.

• Change in Cockroach Phobia Beliefs Questionnaire (SBQ; adapted from Spider Phobia Beliefs Questionnaire; SBQ, Arntz, Lavy, van der Berg & van Rijssoort, 1993).

  Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.

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

  Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.

• Change in Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976).

  Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.

Other Outcomes (4)

• Change in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)

  Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.

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

  Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.

• Change in The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994).

  Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.

Study Arms (2)

Treatment with Multiple Stimuli

EXPERIMENTAL

Projection-based augmented reality therapy (P-ARET) with Multiple Stimuli (MS) (P-ARET MS). Intervention group that receives P-ARET treatment varying the stimuli available in the system (different cockroaches in colour, size, etc).

Behavioral: Projection-based augmented reality therapy (P-ARET)

Treatment with Single Stimuli

EXPERIMENTAL

Projection-based augmented reality therapy (P-ARET) with Single Stimuli (SS) (P-ARET SS). Intervention group that receives P-ARET treatment using a single stimulus (one cockroach).

Behavioral: Projection-based augmented reality therapy (P-ARET)

Interventions

Projection-based augmented reality therapy (P-ARET) BEHAVIORAL

The intervention will be based on exposure therapy to cockroaches using P-ARET. The treatment will follow the guidelines of the "one-session treatment" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention.

Treatment with Multiple Stimuli; Treatment with Single Stimuli

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being at least 18 years old
• Meeting DSM-5 diagnostic criteria for SP (animal subtype) to cockroaches -
• Having a minimum of six-month duration of the phobia
• Sign an informed consent
• Presenting a score of at least 4 on the fear and avoidance scales of the diagnostic interview applied

You may not qualify if:

• Presence of another severe mental disorder that requires immediate attention
• Having current alcohol or drug dependence or abuse, psychosis or severe organic illness
• Currently being treated in a similar treatment program
• Being capable of inserting their hands in a plastic container with a cockroach (during the behavioral test)
• Receiving other psychological treatment during the study for cockroach phobia
• Start receiving pharmacological treatment during the study (or in case of being already taking them, change the drug or dose)

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12071, Spain

RECRUITING

Related Publications (3)

• Shiban Y, Schelhorn I, Pauli P, Muhlberger A. Effect of combined multiple contexts and multiple stimuli exposure in spider phobia: A randomized clinical trial in virtual reality. Behav Res Ther. 2015 Aug;71:45-53. doi: 10.1016/j.brat.2015.05.014. Epub 2015 May 28.

  PMID: 26072451 BACKGROUND

• Botella C, Mira A, Moragrega I, Garcia-Palacios A, Breton-Lopez J, Castilla D, Riera Lopez Del Amo A, Soler C, Molinari G, Quero S, Guillen-Botella V, Miralles I, Nebot S, Serrano B, Majoe D, Alcaniz M, Banos RM. An Internet-based program for depression using activity and physiological sensors: efficacy, expectations, satisfaction, and ease of use. Neuropsychiatr Dis Treat. 2016 Feb 23;12:393-406. doi: 10.2147/NDT.S93315. eCollection 2016.

  PMID: 27042067 BACKGROUND

• Palau-Batet M, Breton-Lopez J, Grimaldos J, Diaz-Sanahuja L, Quero S. Improving the efficacy of exposure therapy using projection-based augmented reality for the treatment of cockroach phobia: a randomised clinical trial protocol. BMJ Open. 2023 May 19;13(5):e069026. doi: 10.1136/bmjopen-2022-069026.

  PMID: 37208142 DERIVED

MeSH Terms

Conditions

Phobia, Specific

Central Study Contacts

Soledad Quero, Psychology

CONTACT

615063917; squero@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial with two treatment conditions

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 24, 2020
• Study Start: November 30, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)