Online Psychological Treatment for Rat Phobia Guided by a Virtual Assistant

November 14, 2022 updated by: María Victoria Meza Kubo, Universidad Autonoma de Baja California

Effectiveness of an Online Self-applied Psychological Treatment for Rat Phobia Guided by a Virtual Assistant in the Mexican Population: A Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Victoria M Meza-Kubo, PhD
  • Phone Number: 64915 +52-646 152 8222
  • Email: mmeza@uabc.edu.mx

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Meet the diagnostic criteria for specific phobia towards rats (with a mild to moderate symptomatology).
  2. Have basic digital knowledge and skills (computer and internet use).
  3. Have the necessary technological devices: email, computer / laptop, Smartphone, microphone, internet connection, and Bluetooth.
  4. Sign the informed consent.

Exclusion Criteria:

  1. Receiving another type of psychological or psychopharmacological treatment.
  2. Being diagnosed with another type of anxiety disorder or some psychopathology.
  3. Present any medical condition that puts the life of the person at risk (eg. heart disease, respiratory disease, pregnancy, among others).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-applied treatment with THERA
Participants in this group will use the Self-applied treatment with THERA for a maximum period of one month.
Behavioral: Self-applied treatment for phobias
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.
No Intervention: Control without treatment
Participants in this group keep on a waiting list, after one month, they will receive the self-applied treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the scores of the fear to the rats
Time Frame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
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.
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Change on the avoidance 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
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.
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Change in anxiety symptoms
Time Frame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
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.
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of satisfaction with self-administered treatment with a virtual assistant
Time Frame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
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).
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Perception of the level of effectiveness and ease of use of the self-applied system for fear of rats with a virtual assistant
Time Frame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
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.
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Degree of presence and degree of Judgment of reality
Time Frame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
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).
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Patient perception in the change of fear of rats.
Time Frame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
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.
From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Baja California

Collaborators

Universidad Internacional de Valencia
Universidad Nacional Autonoma de Mexico
Tecnológico Nacional de México

Investigators

  • Study Chair: Sonia M. González Lozoya, MD, UNIVERSIDAD AUTONOMA DEL ESTADO DE BAJA CALIFORNIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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