IRCT | Comparison of the effectiveness of transcranial direct electrical stimulation of the brain (tDCS) with cognitive rehabilitation on selective attention, cognitive flexibility, response inhibition and craving in drug addicts undergoing maintenance treatment.

Protocol summary

Study aim: Comparison of the effectiveness of transcranial direct electrical stimulation of the brain (tDCS) with cognitive rehabilitation on selective attention, cognitive flexibility, response inhibition and craving in drug addicts undergoing maintenance treatment.
Design: A clinical trial with a control group with parallel groups, a blind strain, randomized on 45 patients, which was used for its randomization in the division of groups by lottery method.
Settings and conduct: In terms of data collection, it will be semi-experimental with a pre-test and post-test design with two experimental groups and one control group. The statistical population of the research includes all people suffering from substance abuse disorder who are being treated in the maintenance treatment centers with agonists in the city of Semnan in the first six months of 1402. A cluster sampling method will be used in the selection of subjects. Three centers will be selected from the centers of Semnan city and 15 people from each center will be randomly assigned to two test groups and one control group.
Participants/Inclusion and exclusion criteria: The criteria for entering the research include age between 18 and 60 years, at least two months have passed since the beginning of treatment, not receiving other psychological interventions, a negative test for drug use, not having or having a history of epilepsy, mental retardation, and having at least a high school diploma. .
Intervention groups: Experiment group A will receive ten sessions of transcranial electric current stimulation. The experimental group will receive ten sessions of cognitive rehabilitation, the control group will continue their usual treatment program and will not receive any other intervention.
Main outcome variables: Selective attention, cognitive flexibility, response inhibition and craving

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20230730058968N1

Registration date: 2023-09-05, 1402/06/14

Registration timing: retrospective

Last update: 2023-09-05, 1402/06/14

Update count: 0
Registration date: 2023-09-05, 1402/06/14

Registrant information: Name

Somayeh Bagheri

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 23 3365 4231

Email address

researcher6411@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-08-06, 1402/05/15
Expected recruitment end date: 2023-08-16, 1402/05/25
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the effectiveness of transcranial direct electrical stimulation of the brain (tDCS) with cognitive rehabilitation on selective attention, cognitive flexibility, response inhibition and craving in drug addicts undergoing maintenance treatment.

Public title: Comparison of the effectiveness of transcranial direct electrical stimulation of the brain (tDCS) with cognitive rehabilitation in the treatment of drug addicts undergoing maintenance treatment.
Purpose: Health service research
Inclusion/Exclusion criteria: Inclusion criteria:

At least two months have passed since the start of treatment End of induction and stabilization period Negative drug test Having at least a high school diploma Written consent to enter the research

Exclusion criteria:

Receiving other psychological interventions Having or having a history of epilepsy or other brain diseases and psychosis Mental retardation Taking drugs or anti-anxiety drugs
Age: From 18 years old to 60 years old
Gender: Male

Phase

N/A

Groups that have been masked

Care provider
Outcome assessor

Sample size

Target sample size: 45

Randomization (investigator's opinion)

Randomized

Randomization description

To allocate people in the study groups, the dice throwing method was used so that the numbers 1 and 2 are for the placement of people in the tDCS treatment group, the numbers 3 and 4 are for the placement of people in the cognitive rehabilitation group and the numbers 5 and 6 are for the placement of people in the the control group was defined.

Blinding (investigator's opinion)

Single blinded

Blinding description

In this study, the members of the medical centers from which the patients were selected, as well as the two people who evaluated and completed the tools used in the research, were kept blind to the allocation of the study groups.

Placebo

Not used

Assignment

Parallel

Other design features

Due to the fact that in this study, the participants receive one of cognitive rehabilitation interventions or direct transcranial electrical stimulation of the brain, it was not possible to blind the participants.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Islamic Azad University, Semnan branch

Street address

Islamic Azad University, Semnan Branch, Faculty of Humanities, Department of Psychology

City

Semnan

Province

Semnan

Postal code

3513137111
Approval date: 2023-06-21, 1402/03/31
Ethics committee reference number: IR.IAU.SEMNAN.REC.1402.023

Health conditions studied

1

Description of health condition studied: Addicts undergoing maintenance treatment
ICD-10 code: F11.2
ICD-10 code description: Opioid dependence

Primary outcomes

1

Description: Selective attention
Timepoint: Before the start of the intervention and at the end of the intervention
Method of measurement: Stroop test

2

Description: Cognitive flexibility
Timepoint: Before the start of the intervention and at the end of the intervention
Method of measurement: Dennis and Vander Waal (2010) cognitive flexibility questionnaire (CFI)

3

Description: Response inhibition
Timepoint: Before the start of the intervention and at the end of the intervention
Method of measurement: go / no go test

4

Description: Craving
Timepoint: Before the start of the intervention and at the end of the intervention
Method of measurement: Craving intensity test

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: experimental group A will receive ten sessions of transcranial electric current stimulation. Intervention with OASIS PRO WITH tDCS device from MIND ALIVE company was used. Subjects in this group participated in treatment sessions every other day for ten sessions. Anode electrode was placed in the posterolateral region of the left prefrontal cortex and cathode electrode was placed in the posterolateral region of the right prefrontal cortex, and in each session for 20 minutes, a current of 2 milliamps of direct electric current was passed through the skull of the subjects.
Category: Treatment - Devices

2

Description: Intervention group: The experimental group received ten sessions of cognitive rehabilitation, which used Nejati's cognitive rehabilitation computer program (2010), which includes strengthening working memory, strengthening selective attention, strengthening sustained attention, and strengthening transitional attention. It was performed in 10 sessions of 30 minutes and 3 sessions per week
Category: Treatment - Other

3

Description: Control group: The control group will continue their usual treatment program and receive no other intervention
Category: N/A

Recruitment centers

1

Recruitment center: Name of recruitment center

Ghaem Clinic

Full name of responsible person

Hamid Eghbali

Street address

Ferdows Garden, above three roads of Valiasr

City

Semnan

Province

Semnan

Postal code

3519684713

Phone

+98 23 3334 1401

Email

esmaeili.afsaneh64@yahoo.com

2

Recruitment center: Name of recruitment center

Sadid Center

Full name of responsible person

Ali Asghar Jalali

Street address

Prophet Azam settlement, Noor Square, Fazilat Boulevard, Sadid center

City

Semnan

Province

Semnan

Postal code

7967499351

Phone

+98 23 3345 6895

Email

mjr.psychology@gmail.com

3

Recruitment center: Name of recruitment center

Noor Clinic

Full name of responsible person

Amir Masoud Tartib Godarzi

Street address

Noor Clinic, Shahada Square, 17 Shahrivar St., Imam Hossein St

City

Semnan

Province

Semnan

Postal code

351835646

Phone

+98 23 3342 3519

Email

esmaeili.afsaneh64@yahoo.com

1

Sponsor: Name of organization / entity

Islamic Azad University

Full name of responsible person

Arezoo Tahan

Street address

Kilometer 5 of Damghan Road, Islamic Azad University, Semnan branch

City

Semnan

Province

Semnan

Postal code

۳۷۱۱۱۳۵۱۳۱

Phone

+98 23 3165 6565

Email

info@semnaniau.ac.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: 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

Islamic Azad University

Full name of responsible person

Somayeh Bagheri

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Psychology

Street address

Islamic Azad University, Semnan Branch, Faculty of Humanities, Department of Psychology

City

Semnan

Province

Semnan

Postal code

3513137111

Phone

+98 23 3365 4231

Fax

Email

researcher6411@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Islamic Azad University

Full name of responsible person

Somayeh Bagheri

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Psychology

Street address

Islamic Azad University, Semnan Branch, Faculty of Humanities, Department of Psychology

City

Semnan

Province

Semnan

Postal code

3513137111

Phone

+98 23 3365 4231

Fax

Email

researcher6411@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Islamic Azad University

Full name of responsible person

Somayeh Bagheri

Position

Student

Latest degree

Bachelor

Other areas of specialty/work

Psychology

Street address

Islamic Azad University, Semnan Branch, Faculty of Humanities, Department of Psychology

City

Semnan

Province

Semnan

Postal code

3513137111

Phone

+98 23 3365 4231

Fax

Email

researcher6411@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: All data can be shared after de-identifying individuals
When the data will become available and for how long: Access starts 6 months after results are published
To whom data/document is available: The data will be available to researchers working in scientific and academic institutions
Under which criteria data/document could be used: Data will be accessible for analyzes related to review studies and meta-analysis
From where data/document is obtainable: To receive documents, you can contact researcher6411@gmail.com
What processes are involved for a request to access data/document: The authorized data file will be available to the applicants as soon as they see the message in the e-mail, within a week
Comments

Comparison of the effectiveness of transcranial direct electrical stimulation of the brain (tDCS) with cognitive rehabilitation on selective attention, cognitive flexibility, response inhibition and craving in drug addicts undergoing maintenance treatment.