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The comparison of Transcranial direct current stimulation (tDCS) and Mindfulness-based cognitive therapy (MBCT) effectiveness on food craving reduction in obese people

Protocol summary

Summary
The present study is a Randomized clinical trial. The aim of the present study is comparing the effectiveness of transcranial direct current stimulation (tDCS) and Mindfulness-based cognitive therapy (MBCT) in the reduction of food craving in obese individuals. Participants will be all obese patients referring to the Obesity Clinic in Rasoul Akram Hospital in Tehran. According to the inclusion Criteria, 45 individuals will be selected through available sampling method and they will be divided into 3 groups (tDCS, MBCT and control groups) of 15 subjects through lottery. To this end, three sample members are selected from each sample based on gender, age, type of treatment, and ... most similarities in each draw stage (which will continue to be completed by all sample members). The names of these three are dumped in a container and a name is accidentally selected from the dish. Then, to determine the intervention method, the intervention method (tDCS, MBCT, and control) is selected from a different container in a random manner. Through the use of the no-go choice method at each lottery stage, the distribution of members in the three groups will be the same. The intervention group 1 will be treated with DLPFC cathode left / anodic right tDCS stimulation, receiving through ten 20-minute sessions DLPFC cathode left / anodic right stimulation over 4 weeks, and the intervention group 2 will be treated based on cognitive-based Mindfulness Therapy (MBCT), through 8 sessions during 8 weeks, and the control group will receive only the basic treatment plan of the clinic. Primary outcome measure is a Food Craving and secondary outcome measure is eating style.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052019855N2
Registration date: 2017-09-14, 1396/06/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-14, 1396/06/23
Registrant information
Name
Samira Masumian
Name of organization / entity
Tehran Psychiatry Institue
Country
Iran (Islamic Republic of)
Phone
+98 21 3349 6990
Email address
samira.masumian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Faculty of Behavioral Sciences of Iran University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-20, 1396/05/29
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The comparison of Transcranial direct current stimulation (tDCS) and Mindfulness-based cognitive therapy (MBCT) effectiveness on food craving reduction in obese people
Public title
The comparison of Transcranial direct current stimulation (tDCS) and Mindfulness-based cognitive therapy (MBCT) effectiveness in obese individuals
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Age range of 20 to 50 years; no chronic medical disorders; no change in baseline therapy during 2 months of research.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Subjects will be randomly assigned to three groups: • The group treated with tDCS • The group treated with MBCT • Control group (under the base treatment)

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Faculty of Behavioral Sciences and Mental Health,Mansori street, Sattarkhan street
City
Tehran
Postal code
Approval date
2017-03-26, 1396/01/06
Ethics committee reference number
IR.IUMS.REC 1395.95-04-185-29896

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity

Primary outcomes

1

Description
Food Craving
Timepoint
4 weeks following end of the treatments
Method of measurement
Food Craving Questionnaire (FCQ)

Secondary outcomes

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Intervention groups

1

Description
The patients in tDCS group will receive left cathode / right Anode DLPFC through ten 20-minute sessions during 4 weeks.
Category
Behavior

2

Description
Intervention group 2: MBCT was delivered in groups of 8–12 participants and consisted of eight weekly sessions of 2.5 h plus one day of silent practice between the 6th and 7th session. The training included both formal meditation exercises (i.e. body scan, sitting meditation, walking meditation and yoga), and informal exercises (i.e. bringing present-moment awareness to everyday activities). Cognitive-behavioral techniques included education, monitoring and scheduling of activities, identification of negative automatic thoughts and devising a relapse prevention.
Category
Behavior

3

Description
Control group: This group will receive the usual program of obesity clinic.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Obesity Clinic
Full name of responsible person
Samira Masumian
Street address
Obesity Clinic, Next to Rasoul hospital, Sattarkhan street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Faculty of Behavioral Sciences of Iran University of Medical Science
Full name of responsible person
Dr Malakoti
Street address
Faculty of Behavioral Sciences and Mental Health, Next to Rasoul hospital, Sattarkhan street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Faculty of Behavioral Sciences of Iran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Masumian
Position
PhD candidate in Clinical Psychology
Other areas of specialty/work
Street address
Faculty of Behavioral Sciences and Mental Health, Next to Rasoul hospital, Sattarkhan street
City
Tehran
Postal code
00982133496990
Phone
+98 21 3349 6990
Fax
Email
samira.masumian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Masumian
Position
PhD candidate in Clinical Psychology
Other areas of specialty/work
Street address
Faculty of Behavioral Sciences and Mental Health, Next to Rasoul hospital, Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 3349 6990
Fax
Email
samira.masumian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira M Masumian
Position
PhD candidate in Clinical Psychology
Other areas of specialty/work
Street address
Faculty of Behavioral Sciences and Mental Health, Next to Rasoul hospital, Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 3349 6990
Fax
Email
samira.masumian@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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