Determining the effectiveness of transcranial direct current stimulation (tDCS) and omega-3 supplementation on executive functions, food craving, and depressive symptoms in patients with depression and overweight
Evaluation of the effectiveness of transcranial direct current stimulation (tDCS) and omega-3 alone and together on executive functions and depression and food craving in patients with depression and overweight
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups on 65 adult patients with depression and overweight. We used the Excel function rand function for randomization..
Settings and conduct
The study site is the Psychological and Psychiatric Research Center of Roozbeh Hospital. Women 18 years of age and older who are overweight (BMI above 25) and have a Beck Depression Inventory score above 14 At the first visit, after obtaining informed and free consent to participate in the study, the relevant questionnaires will be completed. They are then randomly divided into four groups of control and intervention. Assignment to groups is hidden from the view of researchers and patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with depression (Beck Depression Score above 14), overweight or obese (BMI≥ 25) and age group 18 to 60 years.
exclusion criteria: unwillingness and consent to participate in the study, being pregnant or breastfeeding with other major psychiatric illnesses such as bipolar depression, schizophrenia, neurological diseases such as epilepsy, history of major head trauma and neurofeedback in two months Lately.
Intervention groups
We have 4 intervention groups as follows:
Group 1: tDCS + omega 3
Group 2: SHAM + placebo
Group 3: SHAM + Omega 3
Group 4: tDCS + placebo
Main outcome variables
Symptoms of depression; Food cravings; Weight; Executive functions; Appetite
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200716048117N1
Registration date:2020-10-18, 1399/07/27
Registration timing:registered_while_recruiting
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Mahla Tabasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 1959
Email address
mahla.tabasi93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of transcranial direct current stimulation (tDCS) and omega-3 supplementation on executive functions, food craving, and depressive symptoms in patients with depression and overweight
Public title
The effect of transcranial direct current stimulation (tDCS) and omega-3 supplementation on depression and weight
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with depression (Beck depression score above 14)
overweight or obesity (BMI≥25)
18 to 60 years old
Exclusion criteria:
Reluctance and satisfaction to participate in the study during pregnancy or lactation
Other major psychiatric illnesses such as bipolar depression, Schizophrenia, neurological diseases such as epilepsy
History of major head trauma and neurofeedback in the last two months
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block, randomization unit: individual, tools and randomization sequence: determined by Excel software. Allocation concealment is done by coding.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, participants, the principal investigator, the clinical caregiver, the evaluator, and the data analyst were all blind.
Description of how to blind:
Group 1: tDCS+ medicine
Group 2: SHAM+ placebo
Group 3: SHAM+ medicine
Group 4: tDCS+ placebo
Groups are hidden from the view of the research team and study participants by coding and placebo.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
Street address
No. 1, Qods Ave., Keshavarz Blvd., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.TUMS.VCR.REC.1398.564
Health conditions studied
1
Description of health condition studied
mild Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
2
Description of health condition studied
Moderate depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
3
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Depression score 14 and above in Beck questionnaire
Timepoint
Measurement of depression at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake
Method of measurement
Beck Depression Inventory
Secondary outcomes
1
Description
Scores of executive functions of individuals in Simple Strop computer software and Wisconsin card computer test
Timepoint
Measurement of executive functions at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake
Method of measurement
Simple Strop computer software and Wisconsin card computer test
2
Description
Individual cravings score in the Summary Food Trait Questionnaire (FCQ-T)
Timepoint
Measurement of food craving at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake
Method of measurement
Summary Food Trait Questionnaire (FCQ-T)
3
Description
People weigh in kilograms and their fat percentage with a pneumatic fat analyzer _ Model BF 511
Timepoint
Measurement of weight and fat percentage at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake
Method of measurement
People weigh in kilograms and their fat percentage with a pneumatic fat analyzer _ Model BF 511
4
Description
Appetite score in a simple appetite questionnaire SNAQ
Timepoint
Measurement of appetite at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake
Method of measurement
Simple appetite questionnaire SNAQ
Intervention groups
1
Description
Intervention group 1: 3 sessions of transcranial direct current stimulation (tDCS), one session per week, 4 sessions of stimulation for 15 minutes each time, and omega-3 supplement (5 cc daily, containing 736 mg (EPA) And 460 mg (DHA)).
Category
Treatment - Other
2
Description
Intervention group 2: Intervention group 1: 3 sessions of transcranial direct current stimulation (tDCS), one session per week, 4 sessions of stimulation for 15 minutes each time, And omega-3 placebo supplement (5 cc daily, soybean oil).
Category
Treatment - Other
3
Description
Third Intervention group: 3 sessions of Sham transcranial direct current stimulation (tDCS) of the brain, one session per week, each session consists of 4 episodes of stimulation, each lasting 15 minutes, and omega-3 supplement (5 cc daily, containing 736 mg of eicosapentaenoic acid (EPA) and 460 mg docosahexaenoic acid (DHA)).0 mg DHA).
Category
Treatment - Other
4
Description
Control group: 3 sessions of Sham transcranial direct current stimulation (tDCS) of the brain, one session per week, each session consists of 4 episodes of stimulation, each lasting 15 minutes, and the placebo of omega-3 (5 cc daily, soybean oil).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital Psychology and Psychiatry Research Center
Full name of responsible person
Mahla Tabasi
Street address
Roozbeh Hospital, Psychiatric and Psychological Research Center, South Kargar St., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3540
Email
pprct@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
سید علی مصطفوی
Street address
Roozbeh Hospital, Psychiatric and Psychological Research Center, South Kargar St., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3540
Email
pprct@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahla Tabasi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Roozbeh Hospital, Psychiatric and Psychological Research Center, South Kargar St., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3540
Email
mahla.tabasi93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Mostafavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Roozbeh Hospital, Psychiatric and Psychological Research Center, South Kargar St., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3540
Email
pprct@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahla Tabasi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Roozbeh Hospital, Psychiatric and Psychological Research Center, South Kargar St., Tehran., Iran.
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3540
Email
mahla.tabasi93@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 is potentially shareable after deleting individual IDs.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The analyzes used in the article are allowed on the delivered data.
From where data/document is obtainable
Requests for data / documentation should only be sent via email to the developer. Responsible person: Dr. Seyed Ali Mostafavi E-Mail: Mostafavi_a@sina.tums.ac.ir
What processes are involved for a request to access data/document
After sending an e-mail to the given documents or files, this information may be sent to the applicant's e-mail as soon as possible.