Comparison of the effectiveness of direct electrical stimulation of the brain (TDCS) and cognitive-behavioral therapy (CBT) in reducing cravings, mood and smoking dependence
Comparison of the effectiveness of direct electrical stimulation of the brain (TDCS) and cognitive-behavioral therapy (CBT) in reducing cravings, mood, and smoking dependence
Design
A controlled clinical trial with parallel, randomized, phase 2 groups on 12 patients. Excel software rand function was used for randomization.
Settings and conduct
Three treatment centers in Mashhad are randomly connected to the intervention and control groups and to the intervention group of the TDSM device and to the control group of cognitive-behavioral therapy (CBT).
Participants/Inclusion and exclusion criteria
Admission requirements: Men who are heavily dependent on smokers and have been referred to a medical center
Conditions of non-entry: History of using psychiatric drugs
Intervention groups
Intervention group: Direct current cranial wall stimulation (tDCS): Each session is for 20 sessions of 30 to 30 minutes according to the treatment protocol and after attaching the cathode and Andy to the test head, stimulate the lateral dorsal region of the prefrontal lobe. we do. 2 mA current
Cognitive-Behavioral Therapy Control Group (CBT): Each session will receive cognitive-behavioral therapy for 9 sessions of 1 to 1.5 hours, depending on the treatment process.
Main outcome variables
Cigarette cravings Nicotine addiction test (FTND) and positive and negative emotion scale test (PNAS) are taken before and after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N51
Registration date:2022-04-08, 1401/01/19
Registration timing:registered_while_recruiting
Last update:2022-04-08, 1401/01/19
Update count:0
Registration date
2022-04-08, 1401/01/19
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-25, 1401/01/05
Expected recruitment end date
2022-08-27, 1401/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of direct electrical stimulation of the brain (TDCS) and cognitive-behavioral therapy (CBT) in reducing cravings, mood and smoking dependence
Public title
Comparison of the effectiveness of direct electrical electrical stimulation (TDCS)
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
People addicted to cigarettes
male gender
Exclusion criteria:
History of mental illness and use of psychiatric drugs
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way using a random number table using the site www.randomization.com. The numbers will be placed in sealed envelopes and when the participants enter, each envelope will be assigned to one of the two groups. The people in even pairs are the control group and the people
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
Ethics Committee of Ferdowsi University of Mashhad
Street address
Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2022-01-30, 1400/11/10
Ethics committee reference number
IR.UM.REC.1400.358
Health conditions studied
1
Description of health condition studied
direct electrical stimulation of the brain (TDCS) and cognitive-behavioral therapy (CBT) in reducing cravings, mood and smoking dependence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tendency to smoke
Timepoint
Before and after the treatment program
Method of measurement
Fagstrom Nicotine Dependence Test (FTND), Positive and Negative Emotion Scale (PNAS) and Smoking Tendency Questionnaire (UTS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6 patients in TDCS treatment of direct current cranial wall stimulation (tDCS): each session according to the treatment protocol is for 10 sessions of 20 to 30 minutes and after connecting the cathode and Andy to the test head of the lateral dorsal region We stimulate the prefrontal lobe. Device name: TDS current intensity 2 mAh. All subjects will respond to the Fagstrom Nicotine Dependence Test (FTND), the Positive and Negative Emotion Scale (PNAS), and the Smoking Attitude Questionnaire (UTS) before and after treatment.
Category
Treatment - Other
2
Description
Control group: 6 people in Cognitive-Behavioral Therapy (CBT): Each session will receive 1 to 1.5 hours of cognitive-behavioral therapy for 9 sessions according to the treatment process, so that the subject of session 1 is to create and maintain motivation for change. Session 2: Identifying and coping with motivating situations, Session 3: Tackling temptation, Session 4: Refusal skills, social situation management and courage ..., Session 5: Making wise decisions when choosing, Session 6: Problem solving, Session 7 is lifestyle modification and coping with boredom, the topic of Session 8 is the management of boredom and boredom and the topic of Session 9 is prevention of recurrence, maintaining stability and termination of treatment. PNAS and Smoking Questionnaire (UTS) will answer before and after treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers in Mashhad
Full name of responsible person
Hossein Share
Street address
Mashhad University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 -91357
Phone
+98 51 3711 2701
Email
raikaravan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 -91357
Phone
+98 51 3841 2081
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Share
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3879 6773
Email
hoshareh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Share
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3879 6773
Email
hoshareh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Share
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3879 6773
Email
hoshareh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available