Protocol summary

Study aim
Comparison and effectiveness of direct transcranial electrical stimulation of the brain and emotion-oriented therapy on the cognitive regulation of emotion, mindfulness and integration of thought and action in patients with obsessive-compulsive disorder
Design
Subjects in the experimental group receive 10 20-minute treatment sessions of 1 mA in the left DLPFC region in such a way that the anodic electrode is placed in the left DLPFC region and the cathode electrode is placed in the shoulder region of the patient. In the control group, the device is turned off. Also, the second experimental group receives 8 sessions of emotional therapy
Settings and conduct
Obsessive-compulsive disorder patients referred to Negha Ainde Clinic in Yazd
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 25 to 45 years, obsessive-compulsive disorder in people for the purpose of screening using the obsessive-compulsive questionnaire, not consuming alcoholic beverages. Exclusion criteria: simultaneous use of other treatment, presence of other accompanying psychiatric disorder, absence More than 2 sessions of treatment, failure to complete the questionnaire in any of the stages of treatment, history of substance abuse, psychoactive drugs or history of brain damage, starting or stopping psychiatric drugs at once one week before the start of treatment or during the sessions treatment
Intervention groups
Intervention and control
Main outcome variables
The mentioned treatment method can be considered as an effective treatment method in order to reduce the symptoms of obsession in patients with obsessive compulsive disorder due to special focus on the category of emotion.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241030063545N1
Registration date: 2024-11-07, 1403/08/17
Registration timing: prospective

Last update: 2024-11-07, 1403/08/17
Update count: 0
Registration date
2024-11-07, 1403/08/17
Registrant information
Name
Mansoure PoorJaneb Elahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3234 7956
Email address
mansoure.poorjaneb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-10, 1403/08/20
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison and effectiveness of direct transcranial electrical stimulation of the brain and emotion therapy focused on the cognitive regulation of emotion, mindfulness and fusion of thought and action in patients with obsessive-compulsive disorder.
Public title
Transcranial Direct Electrical Stimulation of the Brain and Excitatory Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Has Obsessive-Compulsive Disorder Consent to Participate in the Research
Exclusion criteria:
Age
From 25 years old to 45 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
Using the Purposeful Sampling Method, 45 People will be Selected and will be Placed in Two Intervention Groups (15 people in each group) and a Control Group (15 people) Using the lottery Method.
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
Islamic Azad University, Zahedan Branch
Street address
University Street. Zahedan, Iran.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743545
Approval date
2024-10-20, 1403/07/29
Ethics committee reference number
IR.IAU.ZAH.REC.1403.058

Health conditions studied

1

Description of health condition studied
Cognitive regulation of emotion, mindfulness and fusion of thought and action
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
1. Transcranial direct electrical stimulation of the brain is effective on the cognitive regulation of emotions in patients with obsessive-compulsive disorder. 2. Direct transcranial electrical stimulation of the brain is effective on the mindfulness of patients with obsessive-compulsive disorder. 3. Direct transcranial electrical stimulation of the brain is effective on the integration of thought and action in patients with obsessive-compulsive disorder. 4. Emotion-oriented therapy on orderliness Cognitive emotion, mindfulness and fusion of thought and action of patients with obsessive-compulsive disorder are effective. 5. Emotional therapy focused on the cognitive regulation of emotions of patients with obsessive-compulsive disorder is effective. 6. Emotional therapy focused on mindfulness of patients with obsessive-compulsive disorder is effective. 7. Emotional therapy based on the fusion of thought and action of patients with obsessive-compulsive disorder is effective.
Timepoint
This semi-experimental study will be pre-test and post-test with intervention and control groups.
Method of measurement
Padua Obsessive-Compulsive Disorder Questionnaire (PPI): - Cognitive Emotion Regulation Questionnaire (CERQ): Bayer Mindfulness Questionnaire (FFMQ-39): Thought-Act Blend Scale (Shafran et al., 1996):

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Experimental group of transcranial direct electrical stimulation of the brain
Category
Treatment - Other

2

Description
Intervention group: Excited experimental group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Future Look Clinic
Full name of responsible person
Mansoura Pourjanmollahi
Street address
Shahid Bahonar St., in front of Hosseinieh Mahdieh
City
Ardekan
Province
Yazd
Postal code
8951833879
Phone
+98 35 3223 4713
Email
Jamal.shaker@live.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sophia Khanghahi
Street address
Zahedan University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743545
Phone
+98 54 3344 3600
Email
sofia67khaneghaie@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Dr. Sophia Khanghahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Street, Islamic Azad University Complex, Zahedan Branch
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743545
Phone
+98 913 244 4611
Email
sofia67khaneghaie@ymail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sophia Khanghahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Street, Islamic Azad University Complex, Zahedan Branch
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743545
Phone
+98 913 244 4611
Email
sofia67khaneghaie@ymail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sophia Khanghahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Street, Islamic Azad University Complex, Zahedan Branch
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743545
Phone
+98 913 244 4611
Email
sofia67khaneghaie@ymail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The thesis will be attached. Irandak
When the data will become available and for how long
After the final defense of the thesis
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific use
From where data/document is obtainable
Irandak
What processes are involved for a request to access data/document
According to the rules of Irandak
Comments
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