Comparison of the effectiveness of exposure-based one-session with multi-session treatment on psychological symptoms, inflammatory-gene expression, and level of cytokines and hormones, in individuals with specific phobia.
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General information
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46
46
Yes
No
1
2017-12-21, 1396/09/30
2018-11-21, 1397/08/30
20172018-1211-21 00:00:00
2018-09-03, 1397/06/12
2019-07-03, 1398/04/12
20182019-0907-03 00:00:00
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2018-11-21, 1397/08/30
2018-11-21 00:00:00
empty
2019-05-20, 1398/02/30
2019-05-20 00:00:00
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2019-05-20, 1398/02/30
2019-05-20 00:00:00
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Fixing errors in entering the start and end dates of the clinical trial.
It should be noted that this study was a prospective study and sampling of clients was done after registration and approval of the clinical trial.
Fixing errors in entering the start and end dates of the clinical trial. It should be noted that this study was a prospective study and sampling of clients was done after registration and approval of the clinical trial.
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تحصیح اشتباه در ورود تاریخ شروع و خاتمه کارآزمایی بالینی.
لازم به ذکر است که این مطالعه يک بررسی آینده نگر بوده است و نمونه گیری از مراجعین بعد از ثبت و تایید کارآزمایی بالینی صورت گرفته است.
تحصیح اشتباه در ورود تاریخ شروع و خاتمه کارآزمایی بالینی. لازم به ذکر است که این مطالعه يک بررسی آینده نگر بوده است و نمونه گیری از مراجعین بعد از ثبت و تایید کارآزمایی بالینی صورت گرفته است.
Protocol summary
Study aim
Comparison of the efficacy of one-session with multi-session exposure therapy in reducing biological and psychological symptoms of a specific phobia disorder (Rat)
Design
Parallel therapeutic groups include a one-session and multi-session treatment. In each treatment group, 20 participants divided into 4 groups containing 5 individuals for group therapy. Participants are randomly divided into groups
Settings and conduct
The process consists of a baseline assessment stage in which biomarkers and psychological symptoms of subjects are assessed before any animal exposure. The exposure stage, which students are exposed with the rats on the basis of the protocol and then are guided for blood sampling and psychological assessments. The intervention stage, which students received either one-session or multi-session therapy, and a post-treatment evaluation stage that students will be treated in the same way as the second stage with the animal and the evaluations.
Participants/Inclusion and exclusion criteria
The population of the study includes female college students aged 18-35, who are afraid of rats. Inclusion criteria:
1- Ages 18-35 years
2. Having a BMI of 18-35 kg/m2
3- Stay in the Luteal phase
4. Having a specific (rat) phobia based on DSM-V criteria
Exclusion criteria:
1 - A history of previous exposure to mice and rats
2- Using anti-anxiety, psychoactive, beta-blockers, hormonal, or contraceptive drugs
3- Smoking cigarette or tobacco
4. Having history of mental, cardiovascular, metabolic or chronic diseases
Intervention groups
The first group received one-session treatment, and the second group received a four-session treatment for rat phobia.
Main outcome variables
Independent variable: One-session treatment; Multi-session therapy;
Dependent variables: Psychological symptoms of rat phobia; IL-1 gene expression; Gene expression of Nfkb ; Serum cortisol; serum IL-6; blood pressure; pulse.
General information
Reason for update
Fixing errors in entering the start and end dates of the clinical trial.
It should be noted that this study was a prospective study and sampling of clients was done after registration and approval of the clinical trial.
Acronym
IRCT registration information
IRCT registration number:IRCT20171123037602N1
Registration date:2018-09-30, 1397/07/08
Registration timing:prospective
Last update:2020-05-11, 1399/02/22
Update count:1
Registration date
2018-09-30, 1397/07/08
Registrant information
Name
Camellia Hemyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 3659
Email address
camellia.hemyari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-07-03, 1398/04/12
Actual recruitment start date
2018-11-21, 1397/08/30
Actual recruitment end date
2019-05-20, 1398/02/30
Trial completion date
2019-05-20, 1398/02/30
Scientific title
Comparison of the effectiveness of exposure-based one-session with multi-session treatment on psychological symptoms, inflammatory-gene expression, and level of cytokines and hormones, in individuals with specific phobia.
Public title
Comparison of the effectiveness of one session and multi-session treatment in individuals with specific phobia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Body Mass Index in the range of 18 to 35 kg/m2
Being at Luteal phase
Having a specific phobia disorder (mouse and rat) based on DSM-V criteria, using the ADIS-IV structured interview
Exclusion criteria:
History of a previous exposure to mice and rats
Using anti-anxiety, psychoactive, beta-blocker, hormonal or contraception drugs
Smoking cigarette or tobacco
Having the history of mental illness, cardiovascular, metabolic or other chronic diseases
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
3
Three samples are taken from each person. At each turn, a blood sample, blood pressure test and psychological assessment by a questionnaire are performed.
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number tables
Blinding (investigator's opinion)
Single blinded
Blinding description
Those that measure biological and psychological assessments and analyze the data are unaware of the treatment groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin,
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.USWR.REC.1396.256
Health conditions studied
1
Description of health condition studied
Rat phobia
ICD-10 code
F40.21
ICD-10 code description
Animal type phobia
Primary outcomes
1
Description
Specific phobic disorder based on DSM-V diagnostic criteria
Timepoint
1- Baseline measurement 2- Pre-treatment measurement after facing with laboratory rat 3- Post-treatment evaluation after exposure to the animal
Method of measurement
In this study, an anxiety disorder interview (ADIS-IV) is used to diagnose the disorder.
2
Description
Fear of the rat based on mice phobia questionnaire
Timepoint
1- Baseline measurement 2- Pre-treatment measurement after facing with laboratory rat 3- Post-treatment evaluation after exposure to the animal
Method of measurement
The 18-point questionnaire for fear of mice (adapted from the Spider-Man's Questionnaire (FSQ), Szymanski, O’Donohue, 1995)
3
Description
Serum cortisol level
Timepoint
1- Baseline measurement 2- Pre-treatment measurement after facing with laboratory rat 3- Post-treatment evaluation after exposure to the animal
Method of measurement
Cortisol measurement by Enzyme-Associated Immunosorbent Assay
4
Description
The expression level of IL-1β encoding gene in white blood cells
Timepoint
1- Baseline measurement 2- Pre-treatment measurement after facing with laboratory rat 3-Post-treatment evaluation after exposure to the animal
Method of measurement
The expression of this gene relative to a house keeping gene (such as beta-actin) is measured by the Real Time PCR method.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One-session cognitive-behavioral therapy for three hours in accordance with Ost’s manual.
Category
Treatment - Other
2
Description
Intervention group: Exposure-based cognitive-behavioral therapy for specific phobia disorder includes 4 sessions of 2 hours based on Barlow protocol.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Kamiar Zomorodian
Street address
Zand Ave., School of Medicine
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 9411
Fax
+98 71 3234 9411
Email
zomorodian@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences