An interventional study of Self-applied treatment for phobias in Specific Phobia and Anxiety Disorder, sponsored by Universidad Autonoma de Baja California. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Universidad Autonoma de Baja California · Not applicable, Interventional, and Treatment
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.
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.
85 studies on the registry are indexed under Phobia, Specific; 13 are open to participants now.
This study's planned enrollment of 30 is below the median of 74 across 81 interventional studies indexed under Phobia, Specific.
Browse Phobia, Specific studies →Universidad Autonoma de Baja California is the lead sponsor of 33 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in this group keep on a waiting list, after one month, they will receive the self-applied treatment
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.
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.
Time frame: 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.
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
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.
Time frame: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions
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).
Time frame: 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
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
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).
Time frame: 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.
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
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Informed consent form
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.
Access criteria: Through the servers of the journal(s) where we will publish the articles.
Start is estimated for Jan 2023; primary completion for Mar 2023, 2 months later.
Of 48 non-industry interventional studies with no phase under Phobia, Specific, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 2 months is below that.
Counting every sponsor, half of 49 studies reached it within 28 months; a quarter within 11 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Universidad Autonoma de Baja California