Comparison of the effectiveness of mindfulness based on stress reduction therapy and neurofeedback training on the clinical symptoms of individual with generalized anxiety disorder
The aim of this study is compare effectiveness of mindfulness based on stress reduction therapy and neurofeedback training on the clinical symptoms of individual with generalized anxiety disorder.
Design
In a quasi-experimental study, 30 individual with generalized anxiety disorder who referring to counseling centers of Neyshabur will select by available sampling method and will divide to mindfulness based on stress reduction therapy and neurofeedback training. The first group will participate in 8 sessions of mindfulness based on stress reduction, while second group will participate in sessions of neurofeedback training.
Settings and conduct
Counseling center of the university of Neyshabur.
We have two groups: mindfulness based on stress reduction and neurofeedback training, which is treated with mindfulness treatment in eight sessions and neurofeedback training in 15 sessions.
Participants/Inclusion and exclusion criteria
persons with generalized anxiety disorders
Intervention groups
mindfulness based on stress reduction therapy and neurofeedback training
Main outcome variables
Generalized anxiety disorder
General information
Reason for update
Acronym
MBSR & NT
IRCT registration information
IRCT registration number:IRCT20180523039809N1
Registration date:2018-08-27, 1397/06/05
Registration timing:registered_while_recruiting
Last update:2018-08-27, 1397/06/05
Update count:0
Registration date
2018-08-27, 1397/06/05
Registrant information
Name
Tahmine Mirisargazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3355 1149
Email address
tahmine.miri@chmail.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-29, 1397/05/07
Expected recruitment end date
2018-09-29, 1397/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of mindfulness based on stress reduction therapy and neurofeedback training on the clinical symptoms of individual with generalized anxiety disorder
Public title
Comparison of the effectiveness of mindfulness based on stress reduction therapy and neurofeedback training
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inflammation to generalized anxiety disorder
Lack of synchronization in other treatment programs
Informed consent
Participation to pharmaceutical and non-pharmaceutical treatment programs during this project
Exclusion criteria:
Use of psychiatric drugs
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Flip the coin
One of the groups was considered the lion and the second group was considered the line and we threw the coin according to the size of the sample group.
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 Islamic Azad University, Neishabour Branch
Street address
Research Blvd, Neishabour Azad University, Office Building
City
Neyshabour
Province
Razavi Khorasan
Postal code
4979155581
Approval date
2017-08-16, 1396/05/25
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1396.4
Health conditions studied
1
Description of health condition studied
generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Generalized anxiety disorder
Timepoint
3 Month
Method of measurement
generalized anxiety disorder 7-item scale (2006), Penn state worry questionnaire (1990), intolerance of uncertainty scale (1994), metacognition questionnaire (2004) & EEG Neurofeedback Tool & Protocol of mindfulness based on stress reduction therapy.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mindfulness based on stress reduction therapy,Treatment protocol: mindfulness based on stress reduction, number of treatment sessions: 8 sessions, 150 min, once a week, treatment is done in group,
Category
Treatment - Other
2
Description
Intervention group: neurofeedback training,Training is conducted in 15 sessions and three times a week for 45 minutes. Training is done with the ProComp2 device.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Advice and Psychology Services of Azad University, Neishabour
Full name of responsible person
MR Mahroghi
Street address
Noishabour Blvd Research Center, Neishabour Azad University, Faculty of Humanities, Psychological Consulting and Services
City
neyshabour
Province
Razavi Khorasan
Postal code
4979155581
Phone
+98 17 3355 1149
Email
tahmine.miri@chmail.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
No special institution has been sponsored.
Full name of responsible person
Tahmine miri sargazi
Street address
NO. 13, Etemadi ave., Basij squer
City
Gonbad
Province
Golestan
Postal code
4975164571
Phone
+98 17 3355 1149
Email
Tahmine.miri@chmail.ir
Grant name
0
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
No special institution has been sponsored.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahmine miri sargazi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 13.,Shahid Etemadi St.,Basij Square
City
Gonbad
Province
Golestan
Postal code
4975164571
Phone
+98 17 3355 1149
Email
Tahmine.miri@chmail.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Mansuri
Position
Profossor
Latest degree
Ph.D.
Other areas of specialty/work
Professor
Street address
Research Blvd. Islamic Azad University, Neishabour
City
Neyshabour
Province
Razavi Khorasan
Postal code
4979155581
Phone
+98 17 3355 1149
Fax
Email
Mansoury_am@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahmine miri sargazi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 13, Shahid Etemadi St., Basij Square
City
Gonbad
Province
Golestan
Postal code
4975164571
Phone
+98 17 3355 1149
Email
Tahmine.miri@chmail.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable persons.
When the data will become available and for how long
Upon completion of research and becoming an article,Six months after printing results
To whom data/document is available
All Scholars & researchers
Under which criteria data/document could be used
Participants' information content is not distributed due to privacy issues, please do not request.
From where data/document is obtainable
tahmine.miri@chmail.ir
What processes are involved for a request to access data/document