Online Psychological Treatment for Rat Phobia Guided by a Virtual Assistant
Primary Purpose
Specific Phobia, Anxiety Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-applied treatment for phobias
Sponsored by

About this trial
This is an interventional treatment trial for Specific Phobia focused on measuring Virtual therapeutic assistant, Small animal phobia, Exposure therapy, Self-applied treatment, Serious games, 360º videos
Eligibility Criteria
Inclusion Criteria:
- Meet the diagnostic criteria for specific phobia towards rats (with a mild to moderate symptomatology).
- Have basic digital knowledge and skills (computer and internet use).
- Have the necessary technological devices: email, computer / laptop, Smartphone, microphone, internet connection, and Bluetooth.
- Sign the informed consent.
Exclusion Criteria:
- Receiving another type of psychological or psychopharmacological treatment.
- Being diagnosed with another type of anxiety disorder or some psychopathology.
- Present any medical condition that puts the life of the person at risk (eg. heart disease, respiratory disease, pregnancy, among others).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self-applied treatment with THERA
Control without treatment
Arm Description
Participants in this group will use the Self-applied treatment with THERA for a maximum period of one month.
Participants in this group keep on a waiting list, after one month, they will receive the self-applied treatment
Outcomes
Primary Outcome Measures
Change in the scores of the fear to the rats
It is a questionnaire that has been adapted from the Fear of Spider Questionnaire for this, the word spiders have been modified for rats and the questions have been adapted to assess phobia rats. The Fear of Spiders Questionnaire has been adapted into Castilian Spanish, is a self-reported instrument that contains 18 items that assess fear of spiders. The items are answered on a seven-point Likert scale (0 = "it is not characteristic of me" up to 6 = "it is very characteristic of me"), the minimum score is 0 and the maximum score is 108. It is expected a statistically significant change (P < 0.05) for the fear of the rat.
Change on the avoidance of the presence of the rat.
The Fear Questionnaire contains 23 items that evaluate a total of 5 subscales: agoraphobia, phobia of blood and wounds, social phobia, concern about feeling anxious and depressed as well as the assessment of the global present state of phobic symptoms. The first part contains 16 items that assess the frequency with which a person avoids phobic situations on a scale of 0 to 8 (0 = I do not avoid it and 8 = I always avoid it), the minimum score is 0 and the maximum score is 120 and the second part contains 7 items that evaluate: 1) the degree to which you are worried about feeling anxious and depressed (0 = almost nothing and 8 = very severely worried), the minimum score is 0 and the maximum is 40; 2) the overall severity of the phobic symptoms (0 = there is no phobia and 8 = very severely disturbing /disabling), the minimum score is 0 and the maximum score is 8. It is expected a statistically significant change (P < 0.05) for the avoidance and fear of the presence of the rat.
Change in anxiety symptoms
The State-Trait Anxiety Inventory will be used. It contains 40 statements that are grouped into two self-assessment scales that measure two different dimensions of anxiety, contain four response options with different criteria for each dimension: 1) Anxiety-trait (almost never, some sometimes, frequently and almost always); 2) Anxiety-state (no, little, regular and a lot). Answers are scored 1, 2, 3, and 4 in the positive reagents (the higher the score, the higher anxiety) and 4, 3, 2, and 1 in negative items (the higher the score, the lower the anxiety). The score can range from a minimum score of 20, up to a maximum score of 80. It is expected a statistically significant change (P < 0.05) for symptoms of anxiety.
Secondary Outcome Measures
Level of satisfaction with self-administered treatment with a virtual assistant
The Client Satisfaction Questionnaire contains 8 questions with a total score ranging from 8 to 32 that measures the level of satisfaction of the self-administered treatment with an assistant virtual Thera; and contains a question that explores the degree to which the treatment is perceived as aversive, it is measured on a scale from 0 (not at all) to 10 (very much).
Perception of the level of effectiveness and ease of use of the self-applied system for fear of rats with a virtual assistant
The Telehealth Usability Questionnaire will be used, it contains 12 questions with 7 response options (1 = disagree and 7 = agree) that evaluate the participant's perception in relation to the effectiveness and ease of use of the self-administered treatment.
Degree of presence and degree of Judgment of reality
Two questions will be used that uses a Likert scale from 0 to 10 (0 = not at all and 10 = too much), the first question assesses the degree to which the patient feels immersed in the virtual environment; the second assesses the degree to which the patient perceives the virtual experience as real (exposure of the rats through 360 ° videos).
Patient perception in the change of fear of rats.
An item adapted from the Clinical Global Impression scale will be used, the question assesses the perception that the patient has in relation to the change in fear of rats after treatment. The question contains a 7-point scale (1 = much better and 7 = much worse). The minimum score is 0 and the maximum score is 7.
Full Information
NCT ID
NCT05081323
First Posted
October 5, 2021
Last Updated
November 14, 2022
Sponsor
Universidad Autonoma de Baja California
Collaborators
Universidad Internacional de Valencia, Universidad Nacional Autonoma de Mexico, Tecnológico Nacional de México
1. Study Identification
Unique Protocol Identification Number
NCT05081323
Brief Title
Online Psychological Treatment for Rat Phobia Guided by a Virtual Assistant
Official Title
Effectiveness of an Online Self-applied Psychological Treatment for Rat Phobia Guided by a Virtual Assistant in the Mexican Population: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Baja California
Collaborators
Universidad Internacional de Valencia, Universidad Nacional Autonoma de Mexico, Tecnológico Nacional de México
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The research work proposes an exposure treatment through a virtual therapeutic assistant called Thera, that interacts verbally with the patient, to guide and control exposure therapies for phobias to small animals delivered through several channels at the same time that it analyzes the Physiological records of the patient in real-time to determine their emotional state during the intervention.
In this study it is proposed to evaluate the efficacy of a self-applied treatment where the virtual assistant allows to gradually guide an exposure treatment for rat phobias, taking advantage of intelligent devices for patient monitoring and being considered to determine the progress of the treatment.
Detailed Description
Specific phobias are a common disorder that deteriorates the lives of people who suffer from them. Exposure therapies have been shown to reduce the symptoms produced. However, low- and middle-income countries have the lowest rate of treatment for specific phobia due to multiple barriers that prevent approaching mental health problems, such as the disparity between the number of people who need care and the availability of professionals who can provide psychological services. To reduce the gap in the treatment of mental health problems in low and middle-income countries, the use of internet-based interventions has been proposed since they reduce the cost, the availability of the service, the waiting time, and they can be guided by a minimum amount of therapeutic care, which allows a greater number of people to receive treatment. Among the most effective proposals that have emerged to carry out psychological interventions for Specific Phobia are self-applied treatments. However, one of the main challenges posed by self-administered interventions in reducing the dropout rate of participants, since it is difficult to engage participants, which leads to attrition and non-completion of treatment. Therefore, it is necessary to consider elements that are attractive and motivate the participants to engage with the treatment. One option to increase patient's adherence could be a virtual therapist assistant that is an application focused on the area of health therapies that uses interaction with the user based on voice commands, it requires a reduced cognitive learning load and are accessible to most of the people. The content of the intervention will be self-applied through a web application including the guidance of a virtual therapist assistant. In order to integrate the benefits that Internet-based interventions provides and the assistance of a virtual therapist to guide and personalize the progress of the treatment according to the user.
The study will have two groups : 1) experimental, where the participants carry out the self-applied treatment for rat phobia supported by the virtual therapist assistant; and 2) control, where participants are on a waiting list and afterwards receive the treatment.
The group assignment of participants will be randomized.
Participants in both groups will be measured pre and post the intervention. The measurements to be obtained are the following:
Fear scale. Anxiety scale. Sense of presence and judgment of reality. User's satisfaction. Perception of utility and ease of use. Patient improvement scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia, Anxiety Disorder
Keywords
Virtual therapeutic assistant, Small animal phobia, Exposure therapy, Self-applied treatment, Serious games, 360º videos
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study has two arms, one is the experimental group that receives the treatment and the other is the comparison group that will receive treatment after the 2 months of the experimental group finished. The patients in both groups will be evaluated pre and post/treatment. The participants are assigned randomly to the intervention or comparison group.
Masking
Participant
Masking Description
The participants will not be aware the study includes two conditions. The conditions of the study are only known by the researchers and the Research Ethics Committee.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self-applied treatment with THERA
Arm Type
Experimental
Arm Description
Participants in this group will use the Self-applied treatment with THERA for a maximum period of one month.
Arm Title
Control without treatment
Arm Type
No Intervention
Arm Description
Participants in this group keep on a waiting list, after one month, they will receive the self-applied treatment
Intervention Type
Behavioral
Intervention Name(s)
Self-applied treatment for phobias
Intervention Description
The proposed treatment consists of four stages that use different visual elements to represent and replace a real rat in a gradual exposure treatment for specific phobia for animals. With the order of the stages, the intensity of the phobic stimulus increases. In each stage the participant is gradually exposed to a certain amount of elements that represent a phobic situation or object. Graduality considers an approach with realism, interaction, and intensity. The treatment also includes a virtual therapeutic assistant that guides, provides information, and tries to reduce any alteration captured by the participant's heart rate monitoring through deep breathing exercises.
Primary Outcome Measure Information:
Title
Change in the scores of the fear to the rats
Description
It is a questionnaire that has been adapted from the Fear of Spider Questionnaire for this, the word spiders have been modified for rats and the questions have been adapted to assess phobia rats. The Fear of Spiders Questionnaire has been adapted into Castilian Spanish, is a self-reported instrument that contains 18 items that assess fear of spiders. The items are answered on a seven-point Likert scale (0 = "it is not characteristic of me" up to 6 = "it is very characteristic of me"), the minimum score is 0 and the maximum score is 108. It is expected a statistically significant change (P < 0.05) for the fear of the rat.
Time Frame
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Title
Change on the avoidance of the presence of the rat.
Description
The Fear Questionnaire contains 23 items that evaluate a total of 5 subscales: agoraphobia, phobia of blood and wounds, social phobia, concern about feeling anxious and depressed as well as the assessment of the global present state of phobic symptoms. The first part contains 16 items that assess the frequency with which a person avoids phobic situations on a scale of 0 to 8 (0 = I do not avoid it and 8 = I always avoid it), the minimum score is 0 and the maximum score is 120 and the second part contains 7 items that evaluate: 1) the degree to which you are worried about feeling anxious and depressed (0 = almost nothing and 8 = very severely worried), the minimum score is 0 and the maximum is 40; 2) the overall severity of the phobic symptoms (0 = there is no phobia and 8 = very severely disturbing /disabling), the minimum score is 0 and the maximum score is 8. It is expected a statistically significant change (P < 0.05) for the avoidance and fear of the presence of the rat.
Time Frame
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Title
Change in anxiety symptoms
Description
The State-Trait Anxiety Inventory will be used. It contains 40 statements that are grouped into two self-assessment scales that measure two different dimensions of anxiety, contain four response options with different criteria for each dimension: 1) Anxiety-trait (almost never, some sometimes, frequently and almost always); 2) Anxiety-state (no, little, regular and a lot). Answers are scored 1, 2, 3, and 4 in the positive reagents (the higher the score, the higher anxiety) and 4, 3, 2, and 1 in negative items (the higher the score, the lower the anxiety). The score can range from a minimum score of 20, up to a maximum score of 80. It is expected a statistically significant change (P < 0.05) for symptoms of anxiety.
Time Frame
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Secondary Outcome Measure Information:
Title
Level of satisfaction with self-administered treatment with a virtual assistant
Description
The Client Satisfaction Questionnaire contains 8 questions with a total score ranging from 8 to 32 that measures the level of satisfaction of the self-administered treatment with an assistant virtual Thera; and contains a question that explores the degree to which the treatment is perceived as aversive, it is measured on a scale from 0 (not at all) to 10 (very much).
Time Frame
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Title
Perception of the level of effectiveness and ease of use of the self-applied system for fear of rats with a virtual assistant
Description
The Telehealth Usability Questionnaire will be used, it contains 12 questions with 7 response options (1 = disagree and 7 = agree) that evaluate the participant's perception in relation to the effectiveness and ease of use of the self-administered treatment.
Time Frame
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Title
Degree of presence and degree of Judgment of reality
Description
Two questions will be used that uses a Likert scale from 0 to 10 (0 = not at all and 10 = too much), the first question assesses the degree to which the patient feels immersed in the virtual environment; the second assesses the degree to which the patient perceives the virtual experience as real (exposure of the rats through 360 ° videos).
Time Frame
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Title
Patient perception in the change of fear of rats.
Description
An item adapted from the Clinical Global Impression scale will be used, the question assesses the perception that the patient has in relation to the change in fear of rats after treatment. The question contains a 7-point scale (1 = much better and 7 = much worse). The minimum score is 0 and the maximum score is 7.
Time Frame
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Meet the diagnostic criteria for specific phobia towards rats (with a mild to moderate symptomatology).
Have basic digital knowledge and skills (computer and internet use).
Have the necessary technological devices: email, computer / laptop, Smartphone, microphone, internet connection, and Bluetooth.
Sign the informed consent.
Exclusion Criteria:
Receiving another type of psychological or psychopharmacological treatment.
Being diagnosed with another type of anxiety disorder or some psychopathology.
Present any medical condition that puts the life of the person at risk (eg. heart disease, respiratory disease, pregnancy, among others).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria M Meza-Kubo, PhD
Phone
+52-646 152 8222
Ext
64915
Email
mmeza@uabc.edu.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Domínguez, PhD
Phone
+526644713277
Email
alejandro.dominguez.r@campusviu.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia M. González Lozoya, MD
Organizational Affiliation
UNIVERSIDAD AUTONOMA DEL ESTADO DE BAJA CALIFORNIA
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study.
IPD Sharing Time Frame
This data will be available approximately in April 2023 and it will be permanently available. It will be shared in the databases of the journal where the article(s) will be published.
IPD Sharing Access Criteria
Through the servers of the journal(s) where we will publish the articles.
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Online Psychological Treatment for Rat Phobia Guided by a Virtual Assistant
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