Comparing the effectiveness of cognitive behavioral therapy; Transcranial Direct Current Stimulation and cognitive behavioral therapy with Transcranial Direct Current Stimulation on cognitive abilities of patients with obsessive-compulsive disorder: A randomized controlled trial
The general purpose of this research is to compare the effectiveness of three protocols including cognitive behavioral therapy, direct transcranial electrical stimulation therapy and cognitive behavioral therapy combined with direct transcranial electrical stimulation on the cognitive abilities of patients with obsessive compulsive disorder.
Design
This clinical trial has three groups in the form of parallel interventions on 60 patients, this trial is randomized and single-blind, and a table of random numbers is used for randomization.
Settings and conduct
Sampling of the research is carried out in all faculties of Roudehen University, first, the faculties are randomly selected in clusters, and after identification, 60 people are randomly selected according to the entry and exit criteria using random numbers on the website www.randomizer.org are placed in 3 intervention groups. Placement is done using sealed envelopes that the participants themselves choose and the group code is specified in it, thus the study will remain one-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of obsessive-compulsive disorder and age 18 to 35 years old / Exclusion criteria: use of psychiatric drugs, use of another psychotherapy, absence of two consecutive sessions
Intervention groups
Intervention group 1 receives 12 sessions of cognitive behavioral therapy. Intervention group 2 receives transcranial direct electrical stimulation treatment for 8 sessions. Intervention group 3 will receive a simultaneous combination of cognitive behavioral therapy and transcranial direct electrical stimulation.
Main outcome variables
The improvement of cognitive abilities in the group receiving CBT and TDCS at the same time will be more than the improvement of this variable in the two treatments individually.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230504058067N1
Registration date:2023-05-13, 1402/02/23
Registration timing:prospective
Last update:2023-05-13, 1402/02/23
Update count:0
Registration date
2023-05-13, 1402/02/23
Registrant information
Name
Maryam Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5514 0585
Email address
mrymhssini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-08-20, 1402/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of cognitive behavioral therapy; Transcranial Direct Current Stimulation and cognitive behavioral therapy with Transcranial Direct Current Stimulation on cognitive abilities of patients with obsessive-compulsive disorder: A randomized controlled trial
Public title
Effectiveness of Transcranial Direct Current Stimulation on obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of obsessive compulsive disorder based on the Maudsley questionnaire
Being in the age range of 18 to 35 years
Exclusion criteria:
Absence in two consecutive sessions in each of the treatments
Taking psychiatric drugs
Use of other psychotherapy services
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This controlled clinical trial study is going to be performed in Azad University both male and female students. Initial screening will be performed to determine the baselines. After screening, 60 participants are contacted via simple random sampling and shuffling. Upon arrival at the clinic, each invited person receives a sealed envelope with A, B or C code written on each envelope. This sequence is determined by someone other than the researchers using the site www.randomizer.org. Code A means the group will receive cognitive behavioral therapy; code B means the group will receive Transcranial Direct Current Stimulation and C means the group will receive cognitive behavioral therapy with Transcranial Direct Current Stimulation. Fisher and chi-square tests are also used to homogenize the underlying features.
Blinding (investigator's opinion)
Single blinded
Blinding description
First of all, in order to blind the trial, a PhD student of psychology from the research group, encode participants information. In this project, blinding means more than just keeping the name of the participants are allocated in treatment or control group hidden. The patients will be blinded in the sense that they do not know they are receiving which kind of therapies. So, the participants are prevented from knowing certain information that may somehow influence them.
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, Roudehen Branch
Street address
Academic complex of Islamic Azad University, Roudehen branch, Motahari Blvd., Roudehen Town
City
Roudehen
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.IAU.R.REC.1402.007
Health conditions studied
1
Description of health condition studied
Obsessive compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Cognitive abilities include 8 subscales that are measured by Nejati cognitive abilities questionnaire.
Timepoint
Session 1, Session 5, Final Session, two months after the last session
Method of measurement
Nejati cognitive abilities questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The protocol used for transcranial direct electrical stimulation in this research, according to the background, will be such that the intervention includes 2 milliamps of the anode position at F3 point and the cathode position at F4 point. The intervention consists of 8 sessions, each session of brain stimulation takes 20 minutes (either real or fake) and only one brain stimulation session will take place on each day. Meetings will be held two days a week.
Category
Treatment - Other
2
Description
Intervention group 2: In this group, cognitive behavioral therapy (12 sessions) is used simultaneously with transcranial direct electrical stimulation (8 sessions), so that after receiving 2 milliamperes, the anode position at the F3 point and the cathode position at the point F4 participates in a 45-minute cognitive-behavioral psychotherapy session for 20 minutes. Cognitive behavioral therapy includes psychoeducation about obsessive compulsive disorder, cognitive exercises such as cognitive restructuring, and behavioral exercises such as immersion.
Category
Treatment - Other
3
Description
Control group: In this group, cognitive behavioral therapy, which has the golden standard, is used as a control group. This protocol consists of 12 treatment sessions two days a week, which include psychoeducation about obsessive compulsive disorder, cognitive exercises, and behavioral exercises.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Counseling Center of Islamic Azad University, Roudehen branch
Full name of responsible person
Hosein Ebrahimi_Moghadam
Street address
Counseling Center of Islamic Azad University, Roudehen Branch, Motahari Blvd., RoudehenCity
City
Roudehen
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Phone
+98 21 7650 5891
Fax
Email
info@rudehen.iau.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Ehsani
Street address
Islamic Azad University, Roudehen Branch, Motahari Blvd., Roudehen City
City
Roudehen
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Phone
+98 21 7650 5891
Fax
Email
info@rudehen.iau.ir
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
100
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
Hosein Ebrahimi_Moghadam
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Roudehen Branch, Motahari Blvd., Roudehen City
City
Roudehen
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Phone
+98 21 7650 5891
Email
Hem_psy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Hosseini
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Roudehen Branch, Motahari Blvd., Roudehen City
City
Roudehen
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Phone
+98 21 7650 5891
Email
maryam.h.psychology@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Hosseini
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Roudehen Branch, Motahari Blvd., Roudehen City
City
Roudehen
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Phone
+98 21 7650 5891
Email
maryam.h.psychology@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data obtained from participants will be published unrecognizably in the primary information table in the article. The general data will be shared simultaneously with the publication of the main article.
When the data will become available and for how long
The data will be shared at the same time as the main article publication.
To whom data/document is available
Mainly, this data will be available to academic researchers and clinicians.
Under which criteria data/document could be used
Thereafter publication of the article, a way of requesting data is introduced. Also, researchers can analyze the data only if the researchers agree.
From where data/document is obtainable
Simultaneously with the publication of the article, a way of requesting data is introduced.
What processes are involved for a request to access data/document
Initially, the request is sent to the responsible author, after reviewing the group in order to prevent any kind of abuse, the information is sent in the form of a zip file.