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Comparison of the effectiveness of direct electrical brain movement and cognitive-behavioral therapy in executive function and consumption in individuals with substance abuse

Protocol summary

Study aim
The aim of this study was to compare the effectiveness of motor, brain and cognitive-behavioral therapy in executive functions and consumption in individuals with substance abuse.
Design
A clinical trial with two control groups and one control group, with parallel, randomized groups, on 45 patients. To do this, a random block sequencing website is used.
Settings and conduct
Statistical population: All men who abuse drugs in the 15th district of Tehran in 1400 who referred to addiction treatment and rehabilitation centers in 1399-1400. The sample of the present study was selected from the statistical population using the available sampling method and considering the criteria for entering and leaving the research. The sampling method was non-random and purposeful. 45 men who met the entry criteria for the study were identified and divided into three groups of 15, namely two experimental groups and a control group by random assignment.
Participants/Inclusion and exclusion criteria
Entry criteria: Completion of informed consent form, age range 20 to 40 years, opioid dependence, constant amount of medication (methadone, bo pro norphine, etc.) until the end of the project, having an up-cycle education, being right-handed Exit criteria: History of subcortical direct electrical stimulation of the brain for any disorder, acute or chronic physical and psychological disorders other than addiction, non-opioid dependence, history of seizures or head trauma, having a tummy tuck or implant with a skull, left Being on hand
Intervention groups
Direct brain electrical stimulation intervention was performed on one of the experimental groups and cognitive-behavioral intervention was performed on the other experimental group. The intervention was not performed on the control group and pre-test and post-test were taken.
Main outcome variables
Executive functions; Craving consumption

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220518054902N1
Registration date: 2022-05-28, 1401/03/07
Registration timing: registered_while_recruiting

Last update: 2022-05-28, 1401/03/07
Update count: 0
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
Mohammad Entezamimehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3392 7727
Email address
email4m.mehr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
2022-05-22, 1401/03/01
Actual recruitment end date
2022-08-23, 1401/06/01
Trial completion date
2022-08-23, 1401/06/01
Scientific title
Comparison of the effectiveness of direct electrical brain movement and cognitive-behavioral therapy in executive function and consumption in individuals with substance abuse
Public title
Comparison of the effectiveness of direct electrical brain movement and cognitive-behavioral therapy in executive function and consumption in individuals with substance abuse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Completion of informed consent form, age range 20 to 40 years, opioid dependence, constant amount of medication (methadone, bo pro norphine, etc.) until the end of the project, having an up-cycle education, being right-handed
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
A clinical trial consisting of two control groups and a control group, with parallel, randomized groups, on 45 patients. For random allocation, the block-making method (quadruple blocks) is used. A list of blocks is written and numbers are assigned to them, and finally the treatment allocation list is determined based on random numbers. To do this, a random block sequencing website is used. Random block sequencing is provided to a specific person outside the research team who is responsible for random allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Both experimental groups for blinding in 10 sessions, one group participates in cognitive-behavioral therapy sessions and the other group participates in sessions of electrical stimulation of the brain, and the control group does not receive any intervention. Attempts are made to schedule the meetings in such a way that the members of the control and intervention group do not collide with each other and are not informed about the content of each other's meetings. Also, the participant is not aware of the result.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University- Arak Branch
Street address
No. 47, Eighth floor, Industry building, Zahiralaslam St., Jomhory St, Tehran.
City
Tehran
Province
Tehran
Postal code
1146835785
Approval date
2022-05-21, 1401/02/31
Ethics committee reference number
IR.IAU.ARAK.REC.1401.027

Health conditions studied

1

Description of health condition studied
People with a history of substance abuse
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Direct electrical stimulation of the brain, Cognitive-behavioral therapy
Timepoint
3 month
Method of measurement
Therapeutic intervention of electrical stimulation of the brain, cognitive-behavioral therapy protocol

Secondary outcomes

empty

Intervention groups

1

Description
Direct electrical stimulation period of the brain: twice a week on Sundays and Thursdays for 5 consecutive weeks as follows. How to hold meetings. The treatment plan will be the same in all 10 sessions of intervention in terms of type, severity and duration of stimulation. During the treatment sessions, the subject will sit on a comfortable chair, then according to the standard system of 10 to 20 electroencephalography reported by Jasper, points will be identified on the subject's head and the anode electrode on the lateral dorsal lateral cortex and the cathode electrode on the lateral dorsal cortex. His right forehead will be placed and applied with a pair of sponge electrodes measuring 3.5 cm of direct current generated by a current of 2 mA with 30 seconds of up and down for 20 minutes. During the stimulation, the subject sits on a chair and does not perform a specific task.
Category
Treatment - Other

2

Description
Group cognitive-behavioral therapy will be based on Beck theory's cognitive-behavioral therapy. This intervention will be taught in 10 sessions as follows: Session 1: initial acquaintance and establishing a therapeutic relationship, raising the main complaints of women, brief introduction of the type of treatment, collaborating with the research sample in determining the goals of the treatment protocol, determining the relationship between cognition, Emotion and behavior, choosing goals and identifying goals and agreeing on homework, recording life events. Session 2: Formulation of general problems of addicts in the form of cognitive-behavioral model, integration of cognitive triangle in treatment strategies, use of standard behavioral activation techniques , Redesigning negative spontaneous thoughts and presenting dysfunctional thoughts record sheet. Session 3: Continuing to work with spontaneous thoughts, examining patients' dysfunctional thoughts record sheets, challenging spontaneous thoughts by Socrates method. Session 4: Recognizing underlying beliefs and how to activate them in situations Specifically, the use of downward arrow technique, review of some of the patients' target issues. Session 5: Developing awareness of underlying beliefs, strengthening positive self-talk, using behavioral techniques to replace positive thoughts instead of negative thoughts. Session 6: Use of cognitive-behavioral techniques about daring, Problem Solving and Teaching Social Skills to Addicts Session 7: Identify more unconditional and nuclear beliefs, weaken unconditional beliefs by questioning them in a Socratic manner, and rate negative beliefs on a scale of 0 to 100. Session 8: Continued Generating and developing alternative positive beliefs through the development of social and communication skills, developing problem-solving skills and courageous behaviors, grading alternative thoughts, preparing to apply the methods learned in future life situations. Session 9: Skills training Communication, group discussion, supplementary activities, teaching effective verbal response style and active listening skills. Session 10: Teaching self-control and alertness skills, group discussion, providing complementary activities and post-test.
Category
Treatment - Other

3

Description
Control group:
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Addiction Treatment and Rehabilitation Centers, District 15, Tehran
Full name of responsible person
Mohammad Entezamimehr
Street address
No. 47, Eighth floor, Industry building, Zahiralaslam St., Jomhory St, Tehran.
City
Tehran
Province
Tehran
Postal code
1146835785
Phone
+98 21 3392 7727
Email
Email4m.mehr@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic azad university, arak branch
Full name of responsible person
Mohammad Entezamimehr
Street address
No. 47, Eighth floor, Industry building, Zahiralaslam St., Jomhory St, Tehran.
City
Tehran
Province
Tehran
Postal code
1146835785
Phone
+98 21 3392 7727
Email
Email4m.mehr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic azad university, Arak branch
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, arak branch
Full name of responsible person
Mohammad Entezamimehr
Position
M.A. student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 47, Eighth floor, Industry building, Zahiralaslam St., Jomhory St, Tehran.
City
Tehran
Province
Tehran
Postal code
1146835785
Phone
+98 21 3392 7727
Email
Email4m.mehr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic azad university, arak branch
Full name of responsible person
Mohammad Entezamimehr
Position
M.A. student in clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 47, Eighth floor, Industry building, Zahiralaslam St., Jomhory St, Tehran.
City
Tehran
Province
Tehran
Postal code
1146835785
Phone
+98 21 3392 7727
Email
Email4m.mehr@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic azad univrsity, arak branch
Full name of responsible person
Mohammad Entezamimehr
Position
M.A. student in psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 47, Eighth floor, Industry building, Zahiralaslam St., Jomhory St, Tehran
City
Tehran
Province
Tehran
Postal code
1146835785
Phone
+98 21 3392 7727
Email
Email4m.mehr@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of moral issues
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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