Protocol summary
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Study aim
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Comparison of the efficacy of one-session with multi-session exposure therapy in reducing biological and psychological symptoms of a specific phobia disorder (Rat)
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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The first group received one-session treatment, and the second group received a four-session treatment for rat phobia.
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2018-09-30, 1397/07/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-21, 1397/08/30
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Expected recruitment end date
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2019-07-03, 1398/04/12
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Actual recruitment start date
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2018-11-21, 1397/08/30
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Actual recruitment end date
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2019-05-20, 1398/02/30
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Trial completion date
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2019-05-20, 1398/02/30
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Scientific title
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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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Public title
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Comparison of the effectiveness of one session and multi-session treatment in individuals with specific phobia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization with random number tables
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Those that measure biological and psychological assessments and analyze the data are unaware of the treatment groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-11-21, 1396/08/30
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Ethics committee reference number
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IR.USWR.REC.1396.256
Health conditions studied
1
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Description of health condition studied
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Rat phobia
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ICD-10 code
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F40.21
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ICD-10 code description
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Animal type phobia
Primary outcomes
1
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Description
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Specific phobic disorder based on DSM-V diagnostic criteria
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Timepoint
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1- Baseline measurement 2- Pre-treatment measurement after facing with laboratory rat 3- Post-treatment evaluation after exposure to the animal
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Method of measurement
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In this study, an anxiety disorder interview (ADIS-IV) is used to diagnose the disorder.
2
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Description
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Fear of the rat based on mice phobia questionnaire
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Timepoint
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1- Baseline measurement 2- Pre-treatment measurement after facing with laboratory rat 3- Post-treatment evaluation after exposure to the animal
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Method of measurement
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The 18-point questionnaire for fear of mice (adapted from the Spider-Man's Questionnaire (FSQ), Szymanski, O’Donohue, 1995)
3
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Description
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Serum cortisol level
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Timepoint
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1- Baseline measurement 2- Pre-treatment measurement after facing with laboratory rat 3- Post-treatment evaluation after exposure to the animal
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Method of measurement
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Cortisol measurement by Enzyme-Associated Immunosorbent Assay
4
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Description
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The expression level of IL-1β encoding gene in white blood cells
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Timepoint
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1- Baseline measurement 2- Pre-treatment measurement after facing with laboratory rat 3-Post-treatment evaluation after exposure to the animal
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Method of measurement
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The expression of this gene relative to a house keeping gene (such as beta-actin) is measured by the Real Time PCR method.
Intervention groups
1
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Description
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Intervention group: One-session cognitive-behavioral therapy for three hours in accordance with Ost’s manual.
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Category
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Treatment - Other
2
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Description
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Intervention group: Exposure-based cognitive-behavioral therapy for specific phobia disorder includes 4 sessions of 2 hours based on Barlow protocol.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of social welfare and rehabilitation sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable