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The effect of neurofeedback with pharmacotherapy on cognitive ability and executive function in patients with obsessive – compulsive disorder

Protocol summary

Summary
(1) Main aim: The effect of neurofeedback with pharmacotherapy on cognitive ability and executive function in patients with obsessive – compulsive disorder, Goals: A- Comparison between the efficacy of Neurofeedback and Pharmacotherapy group, and placebo Neurofeedback and Pharmacotherapy group, and Pharmacotherapy group on cognitive abilities and executive functions in patients with obsessive-compulsive disorder. (2) Design: This study is a randomized single blind clinical controlled trial. (3) Setting and conduct: Study population consisted of patients with obsessive-compulsive disorder are referred to hospital in Hamadan farshchian that 45 person divided in 3 groups included Neurofeedback with Pharmacotherapy, placebo Neurofeedback and Pharmacotherapy, Pharmacotherapy alone will be randomly selected. Inclusion criteria: Diagnosis of obsessive-compulsive disorder based on the psychiatrist's interview According to DSM-5 criteria, receiving sertraline, Be at least 18 and up to 60 years, A minimum score of 16 on the Yale Brown Obsessive Compulsive Scale. Exclusion criteria: The people with acute and serious other mental disorders, the types of dementia and cognitive disabilities. Intervention and time: Group 1- In this group patient will receive Neurofeedback 2 times per week for 10 weeks and they also will receive sertraline 20-40 mg for 16 weeks. Group 2- placebo Neurofeedback 2 times per week for 10 weeks and they also will receive sertraline 20-40 mg for 16 weeks. Group 3- Receiving sertraline 10 mg for 16 weeks. All patients before and after the treatments will assess by Yale Brown Obsessive Compulsive Scale, CGI scale, Wisconsin, Stroop and Pasat tests. Outcome variables: Obsessive-compulsive gdisorders, cognitive abilities and executive functions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015030321313N1
Registration date: 2015-03-11, 1393/12/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-03-11, 1393/12/20
Registrant information
Name
Saeid Yazdi-Ravandi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 1066
Email address
yazdiravandi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neurofeedback with pharmacotherapy on cognitive ability and executive function in patients with obsessive – compulsive disorder
Public title
The effect of neurofeedback with pharmacotherapy in treatment of patients with obsessive – compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of obsessive-compulsive disorder based on the psychiatrist's interview According to DSM-5 criteria, Taking sertraline, Be at least 18 and up to 60 years, The ability to read and write, A minimum score of 16 on the Yale Brown Obsessive Compulsive Scale. Exclusion criteria: The people with acute and serious mental disorders such as bipolar disorder, schizophrenia, etc, People with other medical illnesses such as head injuries, Neurologic Diseases, drug allergies, A history of substance abuse, The types of dementia and cognitive disabilities.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Scienses
Street address
Vice chancellor for research and Technology, Hamadan University of Medical Scienses, Shahid Fahmideh Bulv, Hamadan
City
Hamadan
Postal code
6517838678
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
16/35/9/6369/پ

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 symptoms of OCD
Timepoint
before and after the intervention
Method of measurement
Y_BOCS and CGI Scale

Secondary outcomes

1

Description
Cognitive ability and executive function
Timepoint
before and after the intervention
Method of measurement
Wisconsin, Stroop and Pasat tests

Intervention groups

1

Description
Group 2: In this group patients will receive placebo Neurofeedback 2 times per week for 10 weeks and they also will receive sertraline 20-40 mg per day for 16 weeks
Category
Other

2

Description
Group 3: In this group patients will receive sertraline 10 mg per day for 16 weeks.
Category
Treatment - Drugs

3

Description
Group 1: In this group patients will receive Neurofeedback 2 times per week For 10 weeks and they also will receive sertraline 20-40 mg per day for 16 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchain psychiatry hospital
Full name of responsible person
Dr. Ali Ghaleiha
Street address
Farshchain psychiatry hospital, Dibaj st
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashiriyan
Street address
Vice chancellor for research and Technology, Hamadan University of Medical Sciences, Fahmideh Bulv
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamadan Universiety of Medical Sciences
Full name of responsible person
Saeid Yazdi-Ravandi
Position
PhD student
Other areas of specialty/work
Street address
Research Center for Behavioral Disorder And Substance Abuse. Farshchian Hospital, Hamadan
City
Hamadan
Postal code
6517838678
Phone
+98 81 3827 1066
Fax
Email
saeid_yazdiravandi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ali Ghaleiha
Position
Associate Professor
Other areas of specialty/work
Street address
Research Center for Behavioral Disorders and Substance Abuse, Farshchaian Hospital, Hamadan
City
Hamadan
Postal code
6516848741
Phone
+81 38271066
Fax
Email
Alighaleiha@yahoo.co.uk
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
6516848741
Phone
+98 81 3827 1066
Fax
Email
Saeid_yazdiravandi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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