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The effectiveness of cognitive behavioral therapy based on exposure and response prevention on reduction of obsessive compulsive symptoms, changing P300 component and improving executive functioning in scrupulosity and contamination obsessions

Protocol summary

Study aim
Comparison of the effectiveness of cognitive behavioral therapy based on exposure and response prevention on reduction of obsessive compulsive symptoms, changing P300 component and improving executive functioning in scrupulosity with contamination obsessions patients
Design
This was an experimental single­blind randomized controlled trial.In this study, 60 individuals with obsessive-compulsive disorder selected by the use of convenience sampling method.They are included in two treatment groups and a control group. Before the intervention, Beck Depression Inventory, Yale-Brown Compulsive Compulsive Scale, Penn's Religious Compassion Questionnaire, Wisconsin Card Classification Test, and Event-Related Potential Record are performed on the subjects of the three groups. Each person in the intervention group is treated to exposure and prevent the response. After the intervention, the initial measurements will be repeated. To analyze the data, multivariate covariance analysis and Bonferron's post hoc test are used.
Settings and conduct
Measurements of all three groups of study and treatment sessions of intervention groups are performed individually in Yazd Bahman nourepsychiatry clinic. A model of the 24-channel electroencephalograph is used to record patterns of brain waves.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a minimum score on the Yale-Brown Practical Scale and Penn's Religious Compassion Inventory. Exclusion criteria: Comorbidities with Psychiatric disorders, anxiety, major depressive, bipolar, significant neurological disorder personality disorder, Consumption of the drug or simultaneous consumption of the drug for less than two years.
Intervention groups
The first intervention group: scrupulosity The second intervention group: OCD contamination control group
Main outcome variables
obsessive compulsive symptoms, P300 component, executive function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190514043591N1
Registration date: 2019-08-28, 1398/06/06
Registration timing: registered_while_recruiting

Last update: 2019-08-28, 1398/06/06
Update count: 0
Registration date
2019-08-28, 1398/06/06
Registrant information
Name
Farzad Farhoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3827 5678
Email address
farzad.farhoodi@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-29, 1398/05/07
Expected recruitment end date
2019-08-29, 1398/06/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive behavioral therapy based on exposure and response prevention on reduction of obsessive compulsive symptoms, changing P300 component and improving executive functioning in scrupulosity and contamination obsessions
Public title
The effectiveness of cognitive behavioral therapy based on exposure and response prevention on reduction of obsessive compulsive symptoms in scrupulosity and contamination obsessions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ِDiagnosis of obsessive-compulsive disorder through a structured clinical interview based on DSM-IV criteria The minimum score for the diagnosis of obsessive-compulsive disorder in the Yale-Brown Compulsive Scale The minimum score for the diagnosis of obsessive-compulsive disorder in the Penn's Religious Observatory. Aged 18 to 55 years The minimum cycle level of education
Exclusion criteria:
The risk of psychiatric disorder such as anxiety disorders, major depressive disorder, bipolar disorder, significant neurological disorder such as epilepsy, History of severe head injury Impaired vision and hearing Personality disorder Consumption of the drug or the simultaneous consumption of the drug in the last two years
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method is used to allocate individuals in groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were kept blind in this study
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ferdowsi University of Mashhad
Street address
Azadi Square, Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.UM.REC.1398.049

Health conditions studied

1

Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
obsessive compulsive symptoms
Timepoint
Before the intervention, After intervention
Method of measurement
Yale-Brown's Obsessive-Compulsive Scale Religious Penny Questionnaire

2

Description
Executive functioning
Timepoint
Before the intervention, After intervention
Method of measurement
Wisconsin Card Sorting Test

3

Description
P300 component
Timepoint
Before the intervention, After intervention
Method of measurement
ERP

Secondary outcomes

1

Description
Depression
Timepoint
Before the intervention, After intervention
Method of measurement
Beck scale

Intervention groups

1

Description
Intervention group 1: The group of scrupulosity patients under 10-15 sessions of exposure and response prevention.
Category
Treatment - Other

2

Description
Intervention group 2: The group of contamination patients under 10-15 sessions of exposure and response prevention.
Category
Treatment - Other

3

Description
Control group: They receive no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahman nourepsychiatry clinic
Full name of responsible person
Farzad Farhoodi
Street address
Kashani street
City
Yazd
Province
Yazd
Postal code
8918673935
Phone
+98 35 3629 2300
Fax
Email
admin@bahmanclinic.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Dr Ali Mashhadi
Street address
Azadi Square, Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5000
Fax
Email
pr@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ferdowsi University of Mashhad
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
Yazd University of Medical Sciences
Full name of responsible person
Hamid Mirhoseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Central Building of Yazd University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
9177948994
Phone
+98 51 3880 5000
Email
miehoseini.h@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ferdowsi University of Mahhad
Full name of responsible person
Javad Salehi Fadardi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Azadi Square, Mashhad, Razavi Khorasan Province, Iran
City
Mashad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 2415
Email
jsfadardi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ferdowsi University of Mahhad
Full name of responsible person
Farzad Farhoodi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Azadi Square, Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948994
Phone
+98 51 3880 5000
Email
farzad_farhoodi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable participant
When the data will become available and for how long
6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Confidential raw data for secondary analysis will be available to researchers.
From where data/document is obtainable
farzad farhoodi 00989133590446
What processes are involved for a request to access data/document
Submit a proposal from prestigious academic institution
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