Aim of this study is comparison of attention bias modification with pharmacotherapy in Patients with obsessive compulsive disorder.
Design
80 Patients with obsessive compulsive disorder referring to the clinic of Amir Kabir Hospital in Arak with obsessive compulsive disorder based DSMV are enrolled. This study is clinical trial and double blind.
Settings and conduct
80 Patients with obsessive compulsive disorder referring to the clinic of Amir Kabir Hospital in Arak with obsessive compulsive disorder based DSMV are enrolled. This study is clinical trial and double blind.patients will divide in 2 groups by random allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: obsessive compulsive disorder based on DSMV, not having a medical disorder at the same time, not having a low level of consciousness, not having other psychiatric disorders like bipolar disorder, psychosis
depression, mental retardation
Exclusion criteria: not having patient satisfaction, not having patient cooperation, there is an acute period of illness that we have to do another health care for the patient
Intervention groups
patients will divide in 2 groups by random allocation.We treat patients by drugs in first group. We treat patients by attention bias modification (10 sessions of 30 minutes every three times a week).
Main outcome variables
Severity of obsessive-compulsive symptoms, bound attention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N85
Registration date:2018-09-26, 1397/07/04
Registration timing:registered_while_recruiting
Last update:2018-09-26, 1397/07/04
Update count:0
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of attention bias modification with pharmacotherapy in Patients with obsessive compulsive disorder
Public title
comparison of attention bias modification with pharmacotherapy in Patients with obsessive compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obsessive compulsive disorder based on DSMV
Not having a medical disorder at the same time
Not having a low level of consciousness
Not having other psychiatric disorders like bipolar disorder
Psychosis
Depression
Mental retardation
Exclusion criteria:
Not having patient satisfaction
Not having patient cooperation
There is an acute period of illness that we have to do another health care for the patient.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.ARAKMU.REC.1396.284
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
Severity of obsessive-compulsive symptoms
Timepoint
Before and after the meetings
Method of measurement
Clinical observation
2
Description
bound attention
Timepoint
Before and after the meetings
Method of measurement
Clinical observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We treat patients by drugs in first group.
Category
Treatment - Other
2
Description
Intervention group: We treat patients by attention bias modification (10 sessions of 30 minutes every three times a week).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Mostafa Nokani
Street address
Amirkabir hospital, Parastar squre
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
m.nokani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Mostafa Nokani
Position
Assistante professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Amirkabir hospital, Parastar squre
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 863222003
Fax
+98 86 3222 2003
Email
nokani@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mostafa Nokani
Position
Assistante professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Amirkabir hospital, Parastar squre
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 863222003
Fax
+98 86 3222 2003
Email
nokani@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Kadijeh mohsen Porian
Position
resident of psychology
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Parastar squre
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
khmpourian1383@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
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Mostafa Nokani
What processes are involved for a request to access data/document
They have to write letters to the professors and the university