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Improving the Exposure Therapy Through Projection-based Augmented Reality for the Treatment of Cockroach Phobia

Primary Purpose

Animal Phobia

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Alternating single stimulus and multiple stimuli
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Animal Phobia focused on measuring Specific Phobia, Cockroach phobia, Exposure therapy, Augmented Reality, Projection-Based, Single case study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Universitat Jaume I

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Alternating treatments condition - 10 days wait

Alternating treatments condition - 9 days wait

Alternating treatments condition - 13 days wait

Alternating treatments condition - 12 days wait

Arm Description

The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.

The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.

The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.

The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.

Outcomes

Primary Outcome Measures

Change in fear, avoidance, belief in negative thoughts and coping ability with the feared stimulus levels.
Item1: If you see a cockroach in front of you at this moment… To what extent would you be scared of it? Item 2: If you see a cockroach in front of you at this moment… to what extent would you avoid it?, Item 3: If you see a cockroach in front of you at this moment… To what extent would you believe that it is dangerous for you?, Item 4: To what extent you believe that you could cope with a cockroach of different size, colour and shape? Ranged from 0 (nothing) to 10 (very much)
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 evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (interacts with the cockroach).
Change in Behavioral Avoidance Test through AR (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)
Patients will be confronted to a novel projected cockroach (not used before in any treatment condition) 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 evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (interacts with the cockroach).

Secondary Outcome Measures

Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995)
This questionnaire assesses the level of fear to cockroaches. It has 18 items evaluated in a scale ranging from 1 (nothing) to 7 (very much).
Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976).
This instrument evaluates the degree of improvement of the patient' symptoms after the treatment compared to the start. It is ranged from 1 (much worse) and 7 (much better).

Full Information

First Posted
July 1, 2020
Last Updated
November 22, 2022
Sponsor
Universitat Jaume I
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1. Study Identification

Unique Protocol Identification Number
NCT04553120
Brief Title
Improving the Exposure Therapy Through Projection-based Augmented Reality for the Treatment of Cockroach Phobia
Official Title
Improving the Exposure Therapy Through Projection-based Augmented Reality for the Treatment of Cockroach Phobia: A Multiple-baseline Single Case Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to test the efficacy and efficiency of varying the phobic stimuli during the augmented reality (AR) exposure therapy using multiple stimuli versus one single stimulus through projection-based AR (P-ARET) for the treatment of participants diagnosed with cockroach phobia.
Detailed Description
Specific phobia (SP) refers to an extreme and persistent fear of a specific object or situation that is out of proportion to the actual danger or threat. SP is the most prevalent anxiety disorder with substantial impairment and comorbidity. Animal fear is one of the most prevalent subtypes of SP. In vivo exposure is the treatment of choice for this problem, but this technique is associated to limitations in its implementation related to the access and acceptability (i.e., low acceptance on the part of patients and therapists, high dropout rates, limited access to the treatment and, difficulties in its application in the clinical context). Augmented Reality (AR) offers some advantages in delivering the exposure technique: 1) Exposure to multiple virtual stimuli; 2) Going beyond reality; 3) Allowing complete control over the situation; 4) It allows privacy and confidentiality. Particularly, the most significant aspect of AR is that the virtual elements add relevant and helpful information to the physical information available in the real world. The study will follow the guidelines of a multiple-baseline single case design with alternating treatments. Participants (N = 4) who received a diagnosis of SP for cockroaches (DSM-5), will be randomly assigned to different baselines (ranging between 8 and 14 days) and all of them will receive the two experimental conditions: 1) AR exposure therapy with multiple stimuli and; 2) AR exposure therapy with a single stimulus. Five evaluation moments will be included: pre-intervention (baseline), post- intervention, and follow-up at the first month, 6 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Animal Phobia
Keywords
Specific Phobia, Cockroach phobia, Exposure therapy, Augmented Reality, Projection-Based, Single case study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single case, multiple-baseline AB design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alternating treatments condition - 10 days wait
Arm Type
Experimental
Arm Description
The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.
Arm Title
Alternating treatments condition - 9 days wait
Arm Type
Experimental
Arm Description
The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.
Arm Title
Alternating treatments condition - 13 days wait
Arm Type
Experimental
Arm Description
The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.
Arm Title
Alternating treatments condition - 12 days wait
Arm Type
Experimental
Arm Description
The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.
Intervention Type
Behavioral
Intervention Name(s)
Alternating single stimulus and multiple stimuli
Intervention Description
P-ARET for cockroach phobia alternating between two interventions: exposure to a single stimulus (always using the same projected cockroach) and exposure to multiple stimuli (different cockroaches in terms of number, shape, colour and movement). It will be counterbalanced to start the same number of participants in each of the two modalities. The two conditions will be randomly applied for each participant, with the restriction of that each condition will be applied 3 times. There will be 6 weekly sessions of approximately 1 hour. The purpose of this exposure treatment is to confront patients to the phobic stimuli in a controlled manner, which favors the habituation process and allows them to accept that the negative consequences they fear do not actually occur. All exposure sessions should be recorded (patients will sign informed consent for recording prior to treatment initiation).
Primary Outcome Measure Information:
Title
Change in fear, avoidance, belief in negative thoughts and coping ability with the feared stimulus levels.
Description
Item1: If you see a cockroach in front of you at this moment… To what extent would you be scared of it? Item 2: If you see a cockroach in front of you at this moment… to what extent would you avoid it?, Item 3: If you see a cockroach in front of you at this moment… To what extent would you believe that it is dangerous for you?, Item 4: To what extent you believe that you could cope with a cockroach of different size, colour and shape? Ranged from 0 (nothing) to 10 (very much)
Time Frame
Once a day (from the start of the baseline until the end of the treatment) and at 1, 6 and 12 months after the end of the treatment.
Title
Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)
Description
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 evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (interacts with the cockroach).
Time Frame
At the beginning of the intervention and immediately after the treatment
Title
Change in Behavioral Avoidance Test through AR (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)
Description
Patients will be confronted to a novel projected cockroach (not used before in any treatment condition) 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 evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (interacts with the cockroach).
Time Frame
At the beginning of the intervention and immediately after the treatment
Secondary Outcome Measure Information:
Title
Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995)
Description
This questionnaire assesses the level of fear to cockroaches. It has 18 items evaluated in a scale ranging from 1 (nothing) to 7 (very much).
Time Frame
At the beginning of the intervention and immediately after the treatment
Title
Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976).
Description
This instrument evaluates the degree of improvement of the patient' symptoms after the treatment compared to the start. It is ranged from 1 (much worse) and 7 (much better).
Time Frame
At the beginning of the intervention and immediately after the treatment
Other Pre-specified Outcome Measures:
Title
Change in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia
Description
Diagnostic interview for specific phobia based on DSM-IV-TR criteria.
Time Frame
At the beginning of the intervention and immediately after the treatment, and at 1, 6 and 12 months after the end of the treatment.
Title
Change in The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994).
Description
This instrument assesses the severity of symptoms evaluated by the clinician and the scale ranged from 0 (absent) to 8 (very severe).
Time Frame
At the beginning of the intervention and immediately after the treatment
Title
Change in Scale of expectation and satisfaction with the treatment (adapted from Borkovec y Nau, 1972)
Description
This instrument contains 6 items ranged from 0 (nothing) to 10 (very much) assessing the patient's opinions about the treatment, focusing on their expectations and degree of satisfaction.
Time Frame
At the beginning of the intervention and immediately after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Universitat Jaume I
City
Castellón De La Plana
State/Province
Castellón
ZIP/Postal Code
12071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26072451
Citation
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.
Results Reference
background
Citation
Wrzesien, M., Botella, C., Bretón-López, J., del Río González, E., Burkhardt, J. M., Alcañiz, M., & Pérez-Ara, M. Á. (2015). Treating small animal phobias using a projective-augmented reality system: A single-case study. Computers in Human Behavior, 49, 343-353.
Results Reference
background
PubMed Identifier
27042067
Citation
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.
Results Reference
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Improving the Exposure Therapy Through Projection-based Augmented Reality for the Treatment of Cockroach Phobia

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