Anxiety Disorder Clinical Trial
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
NCT number | NCT05081323 |
Other study ID # | 239 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2023 |
Est. completion date | June 2023 |
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | June 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universidad Autonoma de Baja California | Tecnológico Nacional de México, Universidad Internacional de Valencia, Universidad Nacional Autonoma de Mexico |
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions | |
Primary | 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. | From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions | |
Primary | 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. | From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions | |
Secondary | 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). | From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions | |
Secondary | 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. | From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions | |
Secondary | 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). | From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions | |
Secondary | 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. | From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions |
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