Clinical trial NCT05081323: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Specific Phobia
Anxiety Disorder
Keywords: Virtual therapeutic assistant
Small animal phobia
Exposure therapy
Self-applied treatment
Serious games
360º videos
Lead sponsor: Universidad Autonoma de Baja California
Sponsor class: OTHER
Collaborators: name: Universidad Internacional de Valencia
name: Universidad Nacional Autonoma de Mexico
name: Tecnológico Nacional de México
First posted: 2021-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in the scores of the fear to the rats
timeFrame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
measure: Change on the avoidance of the presence of the rat.
timeFrame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
measure: Change in anxiety symptoms
timeFrame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Secondary outcomes:
measure: Level of satisfaction with self-administered treatment with a virtual assistant
timeFrame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
measure: Perception of the level of effectiveness and ease of use of the self-applied system for fear of rats with a virtual assistant
timeFrame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
measure: Degree of presence and degree of Judgment of reality
timeFrame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
measure: Patient perception in the change of fear of rats.
timeFrame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
Other outcomes:
Locations:
Study officials:
affiliation: UNIVERSIDAD AUTONOMA DEL ESTADO DE BAJA CALIFORNIA
name: Sonia M. González Lozoya, MD
role: STUDY_CHAIR
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