Protocol summary

Study aim
Comparison between two therapeutic methods metacognitive therapy based on mindfulness and Transcranial direct current stimulation (tDCS) on experiential avoidance and cognitive emotional regulation and emotional processing on people with General Anxiety Disorder (GAD).
Design
Randomized, Waiting-controlled group, Two experimental groups, Each group has 15 people
Settings and conduct
A study on people referring to a Nedaye Aramesh Ravan clinic in Tehran is done. Patients with generalized anxiety disorder are placed in two experimental and one control groups and treated
Participants/Inclusion and exclusion criteria
Not being under any psychotherapy over the past three months Lack of substance and drug abuse
Intervention groups
metacognitive therapy group, tdcs group, control group
Main outcome variables
experiential avoidance, cognitive emotional regulation, emotional processing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181008041271N1
Registration date: 2019-01-08, 1397/10/18
Registration timing: retrospective

Last update: 2019-01-08, 1397/10/18
Update count: 0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
nastaran mohajeri aval
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 0333
Email address
nastaranmohajeri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of metacognitive therapy based on mindfulness and transcranial direct current stimulation (tDCS) on experiential avoidance and cognitive emotional regulation and emotional processing on people with General Anxiety Disorder (GAD).
Public title
Comparison of the effectiveness of metacognitive therapy based on mindfulness and Transcranial direct current stimulation (tDCS) on people with General Anxiety Disorder (GAD).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Catching general anxiety disorder according to DSM5 Not being under any psychotherapy over the past three months, Not having other psychiatric disorders Lack of substance and drug abuse
Exclusion criteria:
Having a history of epilepsy and mental retardation
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: 45
Randomization (investigator's opinion)
Randomized
Randomization description
individuals were randomly assigned to intervention and control groups. a random number table is used for this task
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic's committee of Ardabil university of medical sciences
Street address
No 284, Rezvan 8 Ave, Rezvan Street
City
Ardabil
Province
Ardabil
Postal code
5615739556
Approval date
2018-10-07, 1397/07/15
Ethics committee reference number
ir.arums.rec.1397.093

Health conditions studied

1

Description of health condition studied
General anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Experiential avoidance
Timepoint
Before therapy and maximum one week after therapy
Method of measurement
Acceptance and Action Questionnaire

2

Description
Cognitive emotional regulation
Timepoint
Before therapy and maximum one week after therapy
Method of measurement
Cognitive emotional regulation scale

3

Description
Emotional processing
Timepoint
Before therapy and maximum one week after therapy
Method of measurement
Emotional processing questionaire

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group1", Fifteen sessions of tdcs treatment each session twenty minutes, It is a nerve therapy technique, Direct and weak electrical current flows into the cortical regions and facilitates or inhibits spontaneous neuronal activity.
Category
Treatment - Devices

2

Description
"Intervention group2": Eight sessions of metacognitive therapy based on mindfulness sessions per hour, Metacognitive therapy deals with the control and interpretation of the thinking process, Treatment involves eliminating worries and disturbing thoughts without avoiding them
Category
Treatment - Other

3

Description
"Control group": Waiting for treatment
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nedaye Aramesh Ravan Clinic
Full name of responsible person
Nastaran Mohajeri Aval
Street address
No4, Shohadaye Sadeghiye Shomali Ave, Sattarkhan Street, Sadeghiye Blvd
City
Tehran
Province
Tehran
Postal code
1484665865
Phone
+98 21 4424 4916
Email
nastaranmohajeri@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Nastaran Mohajeri Aval
Street address
Daneshgah Ave, Mohaghegh Ardabili University
City
Ardabil
Province
Ardabil
Postal code
56199-11367
Phone
+98 45 3351 0140
Email
nastaranmohajeri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mohaghegh Ardabili University
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
Mohaghegh Ardabili University
Full name of responsible person
Nastaran Mohajeri Aval
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No4, Shohadaye Sadeghiye Shomali Ave, Sattarkhan Street, Sadeghiyeh Blvd
City
Tehran
Province
Tehran
Postal code
1484665865
Phone
+98 21 4424 4916
Email
nastaranmohajeri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Personal
Full name of responsible person
Nastaran Mohajeri Aval
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No4, Sadeghiye Shomali Ave, Sattarkhan Street, Sadeghiye Blvd
City
Tehran
Province
Tehran
Postal code
1484665865
Phone
+98 21 4424 4916
Email
nastaranmohajeri@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Personal
Full name of responsible person
Nastaran Mohajeri Aval
Position
Phd student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No4, Shohadaye Sadeghiye Shomali, Sattarkhan Street, Sadeghiye Blvd
City
Tehran
Province
Tehran
Postal code
1484665865
Phone
+98 21 4424 4916
Email
nastaranmohajeri@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
Data is published without personal information of the participants
When the data will become available and for how long
One year after printing
To whom data/document is available
Researchers
Under which criteria data/document could be used
The use of information is possible only by mentioning the source
From where data/document is obtainable
The journals that are supposed to be published there
What processes are involved for a request to access data/document
Download the article from the magazine
Comments
The results of this work are to be published as a paper
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