Comparison of the efficacy of repeated transcranial magnetic stimulation (rTMS) and cognitive behavioral therapy (CBT) on depression, anxiety, emotion regulation and working memory in adolescents with major depressive disorder
Comparison of the efficacy of repeated transcranial magnetic stimulation and cognitive behavioral therapy on depression, anxiety, emotion regulation and working memory in adolescents with depressive disorder
Design
A clinical trial with 2 parallel intervention groups, double blinded is performed on 30 patients who were randomly distributed between 2 groups of 15 people.
Settings and conduct
Among the adolescents with depression who will refer to the psychiatric clinic of Shahid Beheshti Educational and Medical Center in Zanjan, 30 patients are selected and randomly divided into two groups. After obtaining informed consent to participate in the study, the CADS Depression and Anxiety Inventory, the Daniman & Carpenter Working Memory Test, and the CERQ Cognitive Emotion Regulation Questionnaire are presented. After the implementation and completion of the treatment intervention, questionnaires and evaluation tests will be repeated in the form of post-test and one-month follow-up. Patients will be evaluated by someone other than the therapist.
Participants/Inclusion and exclusion criteria
Adolescents 12-19 years with major depression according to the psychiatrist and in accordance with DSM-5; no previous psychological treatment; no previous transcranial direct current stimulation and neurofeedback. Exclusion criteria: psychotic disorders; past history of seizures and epilepsy; electrical or metal object in the body.
Intervention groups
Intervention Group 1: Cognitive-Behavioral Therapy: Treatment sessions are performed in 12-16 sessions (each session approximately 45-60minutes twice a week ). Intervention group2: Each person receives repetitive transcranial magnetic stimulation with a frequency of 2 Hz, over the left dorsolateral prefrontal cortex five times a week for two weeks.
Main outcome variables
Symptoms of depressive disorder; anxiety; emotion regulation; working memory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200824048497N1
Registration date:2021-01-06, 1399/10/17
Registration timing:registered_while_recruiting
Last update:2021-01-06, 1399/10/17
Update count:0
Registration date
2021-01-06, 1399/10/17
Registrant information
Name
Maryam mohammad ali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7628 0897
Email address
mohammadali.maryam20@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-28, 1399/08/07
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of repeated transcranial magnetic stimulation (rTMS) and cognitive behavioral therapy (CBT) on depression, anxiety, emotion regulation and working memory in adolescents with major depressive disorder
Public title
Comparison of the efficacy of Repeated Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy in adolescents with major Depressive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a major depressive disorder diagnosed by a psychiatrist
Age range 12-19 years old
Exclusion criteria:
Infection severe psychiatric disorders such as psychotic spectrum disorders and bipolar disorder
history of epilepsy, seizures and history of head injury
Use drugs and alcohol
Receiving psychological therapies and therapies such as neurofeedback, tDCS and ECT at least one month before entering the study
Age
From 12 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups
First of all each sample is given a specific code, then each code is written on a piece of paper and the papers are poured into a container. According to the sample size in each groups, a few papers will be randomly drawn.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and evaluators are not aware of the intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.ZUMS.REC. 1399. 181
Health conditions studied
1
Description of health condition studied
Mjor depression
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder, single episode, severe without psychotic features
Primary outcomes
1
Description
Symptoms of depressive
Timepoint
Before intervention, After the intervention, One month after the intervention
Method of measurement
Child and Adolescent Depression Inventory (CADS)
Secondary outcomes
1
Description
Symptoms of anxiety
Timepoint
Before intervention, After the intervention, One month after the intervention
Method of measurement
Child and Adolescent Anxiety Inventory CADS
2
Description
Working memory
Timepoint
Before intervention, After the intervention, One month after the intervention
Method of measurement
Daneman, carpenter working memory test
3
Description
Emotion regulation
Timepoint
Before intervention, After the intervention, One month after the intervention
Method of measurement
Emotion Regulation Questionnaire CERQ
Intervention groups
1
Description
Intervention group: Cognitive-behavioral therapy is performed twice a week in 16-12 sessions (45-60 minutes) according to the protocol (Leahy, 2012). After the initial evaluation and recognition of the patient's problems, introduction to treatment begins. After that, intervention and training of cognitive and behavioral techniques are presented.
Category
Treatment - Other
2
Description
Intervention group: each person receives repetitive transcranial magnetic stimulation (rTMS) with a frequency of 2 Hz, over the left dorsolateral prefrontal cortex (lDLPFC). The sessions will be performed five times a week for two weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Mohsen Dadashi
Street address
Beheshti hospital, Ark sq.
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
mohsendadashi@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=29
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi BLVD, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3342 0651
Fax
+98 24 3354 2403
Email
mohsendadashi@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=1
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Ark Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 2403
Email
mohsendadashi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maryam mohammadali
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Ark Square
City
Zanjan
Province
Zanjan
Postal code
15788-45136
Phone
+98 24 3354 2403
Email
mohammadali.maryam20@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maryam mohammadali
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Ark Square
City
Zanjan
Province
Zanjan
Postal code
15788-45136
Phone
+98 24 3354 2403
Email
mohammadali.maryam20@zums.ac.ir
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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Total data after unidentifiable people as SPSS can be shared.
When the data will become available and for how long
Six months later print the results.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
From where data/document is obtainable
DR. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Mohsen Dadashi, Mobile: 0098 9127433559. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology,Maryam Mohammadali, Mobile: +989127959756
What processes are involved for a request to access data/document
Documents will be shared only when the reason for the request is announced by phone or e-mail