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Effectiveness of Ailurophobia treatment by virtual reality compared to metacognition treatment

Protocol summary

Study aim
Effectiveness of Ailurophobia treatment by virtual reality compared to metacognition treatment
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, on 28 patients, is used for randomization by permutation randomization block method.
Settings and conduct
Outpatient clinic of Ibn Sina Hospital uses random permutation block method for random allocation, the analyst & allocator of sample to groups will be unaware of intervention & control groups. Each group has 8 sessions of 45 minutes in 8 weeks, 1 time per week are treated. Group1 will be treated with virtual reality with cat scare software. Group2 is subjected to metacognitive therapy. Before treatment, session 4 & at end of treatment, 1 & 3 months follow-up will be evaluated by Kettle questionnaire & author of construction of ailurophobia.
Participants/Inclusion and exclusion criteria
Entry conditions: Patients who have been confirmed according diagnostic interview have criteria of fear of cats for at least 6 months. are in range of18 to 45 yrs. and are satisfied to participate in this research. Conditions of non-entry: patients who absent for more than 3 sessions in treatment sessions, alcohol or drug addiction, other mental and physical problems at same time, are being not interested
Intervention groups
After approval of psychiatrist to diagnose patient, patients will placed in 2 groups of 14 people aged 18 to 45, men & women. Group 1 will be treated with virtual reality technique with fear of cats software. Group 2 is subjected to metacognitive therapy. Before treatment, 4th session, at end of treatment, 1 & 3month follow-up of Kettle's anxiety questionnaire & creation of ailurophobia questionnaire will be done.
Main outcome variables
Evaluation level of anxiety & avoidance at beginning of intervention, weeks 4th, 8th (the end of the intervention),12th & 20th to follow the effect of treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230105057057N1
Registration date: 2023-03-04, 1401/12/13
Registration timing: registered_while_recruiting

Last update: 2023-03-04, 1401/12/13
Update count: 0
Registration date
2023-03-04, 1401/12/13
Registrant information
Name
Malihe Arjmandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 8220
Email address
salehabadir981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Ailurophobia treatment by virtual reality compared to metacognition treatment
Public title
"Effectiveness of Ailurophobia treatment by virtual reality"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been confirmed according to the diagnostic interview based on the relevant symptom checklist in the fifth edition of the disorder diagnosis, diagnostic and statistical manual of specific phobias (fear of cats) Patients who meet the criteria of fear of cats for at least six months Patients who are in the age range of 18 to 45 Patients are satisfied with participating in this research
Exclusion criteria:
Patients who are absent for more than three sessions in treatment sessions Patients who are dependent on alcohol or drugs Patients who have other mental and physical problems at the same time Patients who are treated with other methods of drug therapy and psychotherapy during the trial period Patients who do not want to continue treatment for any reason
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Permutation random block method is used for random allocation. In this method, 7 blocks of 4 will be randomly selected from the combination of letters A and B. These blocks are AABB, ABBA, BBAA, BAAB, ABAB, BABA. Allocation of letters A and B to treatments will also be done randomly before randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Our method is to use a central service. This service consists of people who work in the center and have no knowledge of the researchers' research, and they will do the secret allocation for the research, that is, the analyst and the sample allocator will be unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ibnesina Hospital, Horeameli Ave., Toos Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Approval date
2020-10-06, 1399/07/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.549

Health conditions studied

1

Description of health condition studied
Ailurophobia
ICD-10 code
F40.2
ICD-10 code description
Specific (isolated) phobias

Primary outcomes

1

Description
Ailurophobia
Timepoint
The beginning of the study, 1 month and 3 months after the start of the study
Method of measurement
"Kettle questionnaire", "construction of ailurophobia author"

Secondary outcomes

empty

Intervention groups

1

Description
After the approval of the psychiatric specialist for the diagnosis of the patient, the patients are placed in 2 groups of 14 people between the ages of 18 and 45, male and female. Each group is treated during 8 sessions of 45 minutes in 8 weeks, once a week. The follow-up will be one month and three months. The first group will be treated with the virtual reality technique with the fear of cats software
Category
Other

2

Description
After the approval of the psychiatric specialist for the diagnosis of the patient, the patients are placed in 2 groups of 14 people between the ages of 18 and 45, male and female. Each group is treated during 8 sessions of 45 minutes in 8 weeks, once a week. There will be a one-month and three-month follow-up. The second group will undergo metacognitive therapy. Before the treatment, the fourth session, and at the end of the treatment, a one- and three-month follow-up will be done with the Kettle anxiety questionnaire and the construction of the ailurophobia questionnaire.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibnesina Hospital
Full name of responsible person
Alireza Ebrahimi
Street address
Horeameli Ave., Toos Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 915 136 5924
Email
Arjmandim981@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
ghayouremobarhan majid
Street address
ghoreishi Department., daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ebrahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Horeameli Ave., Toos Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2701
Email
arjmandim981@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ebrahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibnesina Hospital, Horeameli Ave., Toos Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2701
Email
arjmandim981@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Arjmandi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibnesina Hospital, Horeameli Ave., Toos Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2701
Email
Arjmandim981@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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