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Specific PhobiaNCT05081323

Online Psychological Treatment for Rat Phobia Guided by a Virtual Assistant

A study testing Self-applied treatment for phobias in people with Specific Phobia and Anxiety Disorder, run by Universidad Autonoma de Baja California.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Specific Phobia, Anxiety Disorder
What is being tested?
Self-applied treatment for phobias
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Jan 2023to Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

No sites are listed yet.

Victoria M Meza-Kubo, PhD contact

+52-646 152 8222 ext. 64915

mmeza@uabc.edu.mx

Alejandro Domínguez, PhD contact

+526644713277

alejandro.dominguez.r@campusviu.es

About this study

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

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.

Read the 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.

Being tested
Self-applied treatment for phobias
Keywords
Virtual therapeutic assistant, Small animal phobia, Exposure therapy, Self-applied treatment, Serious games, 360º videos
Medical subject headings
Phobia, Specific, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-applied treatment for phobiasBehavioural

    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.

Study groups in NCT05081323
Study groupRoleWhat they receive
Self-applied treatment with THERAExperimentalParticipants in this group will use the Self-applied treatment with THERA for a maximum period of one month.
Receives: Behavioral: Self-applied treatment for phobias
Control without treatmentNo interventionParticipants in this group keep on a waiting list, after one month, they will receive the self-applied treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions

  2. 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.

    Measured: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions

  3. 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.

    Measured: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions

Secondary outcomes (4)

  1. 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).

    Measured: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions

  2. 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.

    Measured: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions

  3. 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).

    Measured: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions

  4. 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.

    Measured: From 2 to 4 weeks, depending on the development of the patient and the completion of the 4 sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study startJan 2023 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05081323
Sponsor's protocol ID
239
Status last verified
Nov 2022
First submitted
5 Oct 2021
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Albor YC, Benjet C, Mendez E, Medina-Mora ME. Persistence of Specific Phobia From Adolescence to Early Adulthood: Longitudinal Follow-Up of the Mexican Adolescent Mental Health Survey. J Clin Psychiatry. 2017 Mar;78(3):340-346. doi: 10.4088/JCP.15m10569.

    PubMed 28394508

  • Campos D, Breton-Lopez J, Botella C, Mira A, Castilla D, Mor S, Banos R, Quero S. Efficacy of an internet-based exposure treatment for flying phobia (NO-FEAR Airlines) with and without therapist guidance: a randomized controlled trial. BMC Psychiatry. 2019 Mar 6;19(1):86. doi: 10.1186/s12888-019-2060-4.

    PubMed 30841930

  • Felix IB, Guerreiro MP, Cavaco A, Claudio AP, Mendes A, Balsa J, Carmo MB, Pimenta N, Henriques A. Development of a Complex Intervention to Improve Adherence to Antidiabetic Medication in Older People Using an Anthropomorphic Virtual Assistant Software. Front Pharmacol. 2019 Jun 21;10:680. doi: 10.3389/fphar.2019.00680. eCollection 2019.

    PubMed 31281256

  • Jimenez-Molina A, Franco P, Martinez V, Martinez P, Rojas G, Araya R. Internet-Based Interventions for the Prevention and Treatment of Mental Disorders in Latin America: A Scoping Review. Front Psychiatry. 2019 Sep 13;10:664. doi: 10.3389/fpsyt.2019.00664. eCollection 2019.

    PubMed 31572242

  • Wechsler TF, Kumpers F, Muhlberger A. Inferiority or Even Superiority of Virtual Reality Exposure Therapy in Phobias?-A Systematic Review and Quantitative Meta-Analysis on Randomized Controlled Trials Specifically Comparing the Efficacy of Virtual Reality Exposure to Gold Standard in vivo Exposure in Agoraphobia, Specific Phobia, and Social Phobia. Front Psychol. 2019 Sep 10;10:1758. doi: 10.3389/fpsyg.2019.01758. eCollection 2019.

    PubMed 31551840

  • Brown TA, Di Nardo PA & Barlow DH. Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV): Client Interview Schedule. Oxford University Press. 1994.

  • Morán AL, Ramírez-Fernández C & Meza-Kubo V. Design of smart objects of fear with a taxonomy of factors affecting the user experience of exposure therapy systems for small-animal phobias. Journal of Ambient Intelligence and Humanized Computing. 2020

  • Bibiloni N, Torre AC, Angles MV, Terrasa SA, Vazquez Pena FR, Sommer J, Plazzotta F, Luna D, Mazzuoccolo LD. [Validation of a Spanish questionnaire on telemedicine usability]. Medicina (B Aires). 2020;80(6):649-653. Spanish.

    PubMed 33254109

  • Hemyari C, Dolatshahi B, Sahraian A, Koohi-Hosseinabadi O, Zomorodian K. Evaluation of the Effectiveness of One- and Multi-Session Exposure-Based Treatments in Reducing Biological and Psychological Responses to Rat Phobia Among Students. Psychol Res Behav Manag. 2020 Aug 12;13:665-679. doi: 10.2147/PRBM.S256781. eCollection 2020.

    PubMed 32848483

  • Juan MC, Alcaniz M, Monserrat C, Botella C, Banos RM, Guerrero B. Using augmented reality to treat phobias. IEEE Comput Graph Appl. 2005 Nov-Dec;25(6):31-7. doi: 10.1109/mcg.2005.143. No abstract available.

    PubMed 16315475

  • Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. doi: 10.1016/0005-7967(79)90041-x. No abstract available.

    PubMed 526242

  • Palma-Gomez A, Herrero R, Banos R, Garcia-Palacios A, Castaneiras C, Fernandez GL, Llull DM, Torres LC, Barranco LA, Cardenas-Gomez L, Botella C. Efficacy of a self-applied online program to promote resilience and coping skills in university students in four Spanish-speaking countries: study protocol for a randomized controlled trial. BMC Psychiatry. 2020 Apr 5;20(1):148. doi: 10.1186/s12888-020-02536-w.

    PubMed 32248795

  • Ruiz-Garcia A, Valero-Aguayo L. Multimedia intervention for specific phobias: A clinical and experimental study. Psicothema. 2020 Aug;32(3):298-306. doi: 10.7334/psicothema2020.87.

    PubMed 32711663

  • Díaz-Guerrero R, & Spielberger CD. IDARE: Inventario de ansiedad: rasgo-estado. El Manual Moderno. 1975.

  • Guy W. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration. 1976.

Questions about this trial

What is this clinical trial studying?

A study testing Self-applied treatment for phobias in people with Specific Phobia and Anxiety Disorder, run by Universidad Autonoma de Baja California.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Victoria M Meza-Kubo, PhD (+52-646 152 8222 ext. 64915, mmeza@uabc.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05081323, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

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