42 outpatient meeting DSM-IV criteria for GAD who had been referred to sohravardi clinical psychology and psychiatry center in Zanjan city were chosen on the basis of convenient sampling and were randomly assigned in to three treatment group : (MCT n=14), pharmachotherapy (n=14) and neurofeedback treatment (n=14). after signing the consent form of participating in research, All the patients in each groups were treated for8 weeks.The General Anxiety Disorder Scale (GAD-7), were administered blindly in Pre-test and Post-test .Alpha brain waves in occipital area (O1 and O2) using neurofeedback (procomp-5) in Pretest and posttest were registered.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061233946N4
Registration date:2017-08-27, 1396/06/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-27, 1396/06/05
Registrant information
Name
Mohsen Dadashi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3353 4500
Email address
mohsendadashi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Metacognitive therapy (MCT), pharmacotherapy (SSRIs) and EEG biofeedback in Generalized Anxiety Disorders
Public title
Comparing the effectiveness of Metacognitive therapy (MCT), pharmacotherapy (SSRIs) and EEG biofeedback in Generalized Anxiety Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : no medicine consumption 1 month before the intervention; age 18-50 years old; having a minimum grade education.
Exclusion criteria: psychotic disorder; drug dependence.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran Univercity of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Freeway,Tehran
City
Tehran
Postal code
Approval date
2014-09-20, 1393/06/29
Ethics committee reference number
93/105/2955
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
Pretest, post test( 8 months later)
Method of measurement
GAD-7 questionar
2
Description
Depression
Timepoint
Pretest, post test( 8 months later)
Method of measurement
Beck Depression Inventory
Secondary outcomes
1
Description
Alpha Amplitude
Timepoint
Pretest, post test ( 8 months later)
Method of measurement
Baselin by Neuroffedback
Intervention groups
1
Description
10 session MCT based on MCT Manual
Category
Behavior
2
Description
50-100 mg sertraline
20-40 mg citalopram
8 week
Category
Treatment - Drugs
3
Description
EEG Biofeedback:
15 session, Increase Alpha in occipital
15 session, Increase theta in occipital
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sohravardi clinical psychology and psychiatry Center
Full name of responsible person
Mohsen Dadashi
Street address
Zanjan Univercity of Medical Sciences
City
Ark Square, Beheshti Hospital, Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran Univercity of Medical Sciences
Full name of responsible person
Mrs. Hahgshenas
Street address
Iran Univercity of Medical Sciences, Hemmat High Way
City
Tehran
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, Iran Univercity 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
Zanjan University of Medical Sciences and Health Services
Full name of responsible person
Mohsen Dadashi
Position
Assistant Professor, PhD in Clinical Psychology
Other areas of specialty/work
Street address
Arq Square, Behshti Hospital, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3378 9469
Fax
Email
psy.mohsen@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences and Health Services
Full name of responsible person
Mohsen Dadashi
Position
Assistant Professor, PhD in Clinical Psychology
Other areas of specialty/work
Street address
Ark Square, Behshti Hospital, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3378 9469
Fax
Email
psy.mohsen@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences and Health Services
Full name of responsible person
Mohsen Dadashi
Position
Assistant Professor, PhD in Clinical Psychology
Other areas of specialty/work
Street address
Ark Square, Beheshti Hospital, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3378 9469
Fax
Email
psy.mohsen@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)