Online Psychological Treatment for Rat Phobia Guided by a Virtual Assistant

NCT05081323 | Unknown DMC

• 1 other identifier: 239
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Specific Phobia; Anxiety Disorder

Keywords

Virtual therapeutic assistant; Small animal phobia; Exposure therapy; Self-applied treatment; Serious games; 360º videos

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Level of satisfaction with self-administered treatment with a virtual assistant

  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

  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

  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.

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

Study Arms (2)

Self-applied treatment with THERA

EXPERIMENTAL

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

Control without treatment

NO INTERVENTION

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

Interventions

Self-applied treatment for phobias 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.

Self-applied treatment with THERA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead
• Universidad Internacional de Valencia: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator
• Tecnológico Nacional de México: collaborator

Related Publications (16)

• 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.

  PMID: 28394508 BACKGROUND

• 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.

  PMID: 30841930 BACKGROUND

• 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.

  PMID: 31281256 BACKGROUND

• 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.

  PMID: 31572242 BACKGROUND

• 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.

  PMID: 31551840 BACKGROUND

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

  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

  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.

  PMID: 33254109 RESULT

• 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.

  PMID: 32848483 RESULT

• 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.

  PMID: 16315475 RESULT

• 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.

  PMID: 526242 RESULT

• 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.

  PMID: 32248795 RESULT

• 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.

  PMID: 32711663 RESULT

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

  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.

  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.

  PMID: 36791089 DERIVED

MeSH Terms

Conditions

Phobia, Specific; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sonia M. González Lozoya, MD

  UNIVERSIDAD AUTONOMA DEL ESTADO DE BAJA CALIFORNIA

  STUDY CHAIR

Central Study Contacts

Victoria M Meza-Kubo, PhD

CONTACT

+52-646 152 8222; mmeza@uabc.edu.mx

Alejandro Domínguez, PhD

CONTACT

+526644713277; alejandro.dominguez.r@campusviu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not be aware the study includes two conditions. The conditions of the study are only known by the researchers and the Research Ethics Committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 18, 2021
• Study Start: January 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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.