Online Psychological Treatment for Rat Phobia Guided by a Virtual Assistant

NCT ID: NCT05081323

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2023-06-30

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.

Conditions

Specific Phobia; Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-applied treatment with THERA

Participants in this group will use the Self-applied treatment with THERA for a maximum period of one month.

Group Type: EXPERIMENTAL

Self-applied treatment for phobias

Intervention Type: BEHAVIORAL

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.

Control without treatment

Participants in this group keep on a waiting list, after one month, they will receive the self-applied treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Internacional de Valencia

OTHER

Sponsor Role: collaborator

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role: collaborator

Tecnológico Nacional de México

UNKNOWN

Sponsor Role: collaborator

Universidad Autonoma de Baja California

OTHER

Sponsor Role: lead

Responsible Party

María Victoria Meza Kubo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonia M. González Lozoya, MD

Role: STUDY_CHAIR

UNIVERSIDAD AUTONOMA DEL ESTADO DE BAJA CALIFORNIA

Central Contacts

Victoria M Meza-Kubo, PhD

Role: CONTACT

mmeza@uabc.edu.mx

+52-646 152 8222 ext. 64915

Alejandro Domínguez, PhD

Role: CONTACT

alejandro.dominguez.r@campusviu.es

+526644713277

References

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.

Reference Type: BACKGROUND

PMID: 28394508 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30841930 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31281256 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31572242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31551840 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: RESULT

PMID: 33254109 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32848483 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16315475 (View on PubMed)

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.

Reference Type: RESULT

PMID: 526242 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32248795 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32711663 (View on PubMed)

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

Reference Type: RESULT

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.

Reference Type: RESULT

Gonzalez-Lozoya SM, Meza-Kubo V, Dominguez-Rodriguez A, Ramirez-Fernandez C, Bautista-Valerio E, Moreyra-Jimenez L, Moran AL. An internet-based self-applied rat phobia treatment using a Virtual Therapy Assistant: Study protocol for a randomized controlled trial. PLoS One. 2023 Feb 15;18(2):e0281338. doi: 10.1371/journal.pone.0281338. eCollection 2023.

Reference Type: DERIVED

PMID: 36791089 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

239

Identifier Type: -

Identifier Source: org_study_id