Effectiveness of repeated transcranial electrical stimulation with direct current (tDCS) on the improvement of emotional distress and love trauma syndrome in students with romantic relationship breakup: a randomized clinical trial study with sham group
Determining the effectiveness of electrical stimulation with tdcs method on improving love shock and emotional disturbance in students with emotional breakdown.
Design
The present study is a clinical trial with pre-test, post-test and follow-up design with control group.
Settings and conduct
This study will be conducted in the city of Zanjan (Zanjan University) and will be selected from among the students who experienced emotional failure and suffered low trauma in the last year and will be randomly replaced in treatment groups.
Participants/Inclusion and exclusion criteria
Eligibility criteria: having love shock syndrome; experiencing failure in an emotional relationship within the last year. Exclusion criteria: previous history of neurological diseases; brain surgery; epilepsy, seizures, brain injury, head injury or metal brain implantation; diagnosis of depression disorder; bipolar, psychotic disorder or other psychiatric disorder according to DSM5 criteria.
Intervention groups
Two intervention groups and one control group:
1- Intervention group one: stimulating the DLPFC area for ten sessions, two sessions every day, and the duration of each session is 20 minutes.
2-Intervention group two: Stimulation of the VLPFC area for ten sessions, two sessions every day, and the duration of each session is 20 minutes.
3- Control group: Stimulation of the DLPFC area for ten sessions, two sessions every day, and the duration of fake stimulation is 20 minutes per session.
Main outcome variables
Love trauma syndrome; emotional dysregulation; depression; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181013041327N3
Registration date:2023-04-13, 1402/01/24
Registration timing:prospective
Last update:2023-04-13, 1402/01/24
Update count:0
Registration date
2023-04-13, 1402/01/24
Registrant information
Name
jaber Alizadehgoradel
Name of organization / entity
The University of shahid beheshti
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 0055
Email address
j.alizadeh45@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-06-15, 1402/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of repeated transcranial electrical stimulation with direct current (tDCS) on the improvement of emotional distress and love trauma syndrome in students with romantic relationship breakup: a randomized clinical trial study with sham group
Public title
Brain electrical stimulation and romantic relationship breakup
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having love trauma syndrome
The experience of failure in an emotional relationship during the last year
Absence of psychiatric disorders
Exclusion criteria:
No previous history of neurological diseases, brain surgery, epilepsy, seizures, brain injury, head trauma or metal brain implants
Diagnosis of depressive disorder, bipolar disorder, psychotic disorder or other psychiatric disorders based on DSM5 criteria
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
For small studies, random numbers can be used to sort individuals into groups. Persons participating in the research will be given a code or machine number in order to use the random or random numbers table. Since the number of people we want will be selected from 45 people, so the assigned codes and numbers will be double digits. To select sample people from the table, it will randomly start from a table point in the row or column direction. Subjects are then randomly assigned to one of tree study groups using the random number table and receive intervention in the same group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants will be blind to the type of stimulation received (fake or real).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University
Street address
Zanjan, University Blvd, University of Zanjan
City
Zanjan
Province
Zanjan
Postal code
3879145371
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.ZNU.REC.1401.039
Health conditions studied
1
Description of health condition studied
love trauma syndrome
ICD-10 code
F43.10
ICD-10 code description
Post-traumatic stress disorder, unspecified
Primary outcomes
1
Description
Love trauma syndrome
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
Love trauma syndrome Questionnaire
2
Description
Emotion regulation
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
CANTAB Tset
3
Description
Quality of Life
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
Quality of Life Questionnaire
4
Description
Depression
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
Beck Depression Inventory
5
Description
Anxiety
Timepoint
Before the intervention, after the intervention and one months after the intervention
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Electrical stimulation of the dorsolateral prefrontal cortex (DLPFC) area with an intensity of 2 mA- 10 sessions, two sessions every day and the duration of providing stimulation for each session is 20 minutes
Category
Treatment - Other
2
Description
Intervention group: Electrical stimulation of the Ventrolateral Prefrontal Cortex (VLPFC) area with an intensity of 2 mA- 0 sessions, two sessions every day and the duration of providing stimulation for each session is 20 minutes
Category
Treatment - Other
3
Description
Control group: Mock stimulation of orsolateral prefrontal cortex (DLPFC)- 10 sessions, two sessions every day and duration of sham stimulation for each session is 20 minutes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Zanjan
Full name of responsible person
Jaber Alizadehgoradel
Street address
University of Zanjan, University Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4537138791
Phone
+98 24 3305 2441
Email
j.alizadeh45@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research and Technology of Zanjan University
Full name of responsible person
Omid Rahmani
Street address
Kilometer 5 of Tabriz Road, Zanjan University, Central Building, Research and Technology Vice-Chancellor
City
Zanjan
Province
Zanjan
Postal code
4537138791
Phone
+98 24 3305 2441
Email
omid.rahmani@znu.ac.ir
Web page address
https://www.znu.ac.ir/research/tel
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research and Technology of Zanjan 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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Zanjan
Full name of responsible person
Jaber Alizadehgoradel
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Zanjan, University Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4537138791
Phone
098243352441
Email
j.alizadeh45@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Zanjan
Full name of responsible person
Jaber Alizadehgoradel
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Zanjan, University Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
3879145371
Phone
0098243354124
Email
j.alizadeh45@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Zanjan
Full name of responsible person
Jaber Alizadehgoradel
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Zanjan, University Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4537138791
Phone
+98 24 3305 2441
Email
j.alizadeh45@gmail.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
Behavioral data files, study protocols, informed consent forms, and clinical trial reports after identifiable individuals are shared.
When the data will become available and for how long
The access period starts 5 years after the results are published.
To whom data/document is available
Behavioral data for this study will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
En Use of data is permitted only for articles related to the field of emotion.
From where data/document is obtainable
Jaber Alizadehgoradel - j.alizadeh45@gmail.com
What processes are involved for a request to access data/document
Researchers who want to access the data should receive a letter from their workplace university and send it to the responsible person's email address, and the data will be available in less than 1 month.