Comparison of the effectiveness of laser acupuncture, Intensive short-term dynamic psychotherapy and the combination of the two mentioned treatments in improving people with major depressive symptoms with Shedler-Westen Assessment Procedure test
Design
This study is a phase 3 clinical trial. 45 patients are divided into three groups of 15 people receiving laser acupuncture treatment (group I), Intensive short-term dynamic psychotherapy (group II) a combination of laser acupuncture with Intensive short-term dynamic psychotherapy. Before, middle, end, six months after treatment, the Hamilton and Beck questionnaire is completed.
Settings and conduct
Patients with major depressive disorder referred to the New Insight Center will be randomly assigned to one of three treatment groups. Assessment will be done in four times by Hamilton and Beck psychological scales.
Hamilton questionnaire score; Beck questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N37
Registration date:2021-12-21, 1400/09/30
Registration timing:retrospective
Last update:2021-12-21, 1400/09/30
Update count:0
Registration date
2021-12-21, 1400/09/30
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2019-06-22, 1398/04/01
Scientific title
Investigating Effectiveness of Laser Acupuncture Along With Intensive Short-term Dynamic Psychotherapy on Improvement of Major Depression
Public title
Effectiveness of Laser Acupuncture on Improvement of Major Depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Major Depression
Patient satisfaction
Exclusion criteria:
No psychiatric disorders
No substance or alcohol abuse
No mental retardation
No Obsessive-compulsive personality disorder
No hypothyroidism
No endocrine problems
Age
From 25 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Actual sample size reached:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Single-digit random numbers were generated using Excel software. The order of these random numbers was considered as the number of people entering the study. If these numbers were between 1-3, the patient was assigned to the first group, between 4-6 to the second group, between 7-9 to the third group. Following the work of each group, to which 15 patients were assigned, the generated numbers related to that group were removed from the random number production chain.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Biomedical Research of Shahid Beheshti University of medical sciences
Street address
Daneshjoo Blvd, Yaman street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-02-18, 1396/11/29
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.1293
Health conditions studied
1
Description of health condition studied
Major depression
ICD-10 code
6A80.2
ICD-10 code description
Current depressive episode persistent
Primary outcomes
1
Description
Hamilton and Beck questionnaure
Timepoint
Before study-middle session of intervention-end of intervention-six months after
Method of measurement
Hamilton and Beck questionnaure
Secondary outcomes
empty
Intervention groups
1
Description
The first group(acupuncture laser):12 sessions of stimulation of body points (LI4-LI11- ST36-ST40-BL18-BL20-BL21-SP4-SP6-LIV3-LIV8-LIV14-GB15-GB20-GB34-REN12-REN17-P6-DU20-HT7) and punctuation (Heart, pleen, Stomach, Spleen, Shenmen, Anti-depression, Valium, Master Omega) as determined by TCM diagnosis, by continuous contact gallium-aluminum-arsenide laser acupuncture (GaAlAs), with an output power of 200 mW; The wavelength is 980 nm and the dose is 4 j / point.
Category
Treatment - Devices
2
Description
The second group(Control group):Twelve one-hour sessions of "intensive and short-term dynamic psychotherapy" focus on neutralizing defensive reactions and releasing emotions within the framework of the conflict triangle and the personal triangle.
Category
Treatment - Other
3
Description
Group 3, intensive and short-term dynamic psychotherapy and simultaneous laser acupuncture. In this way, they will first attend the laser therapy session and then the psychotherapy session on the same day.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Binesh No clinic center
Full name of responsible person
Nima Ghorbani
Street address
Unit 34, Binesh Building, No12, Kokab dead end, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1947947492
Phone
+98 21 2289 0817
Email
nimaghorbani.site@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi, Vice chancellor of research affair, Shahid Beheshti university of medical sciences
Street address
Yaman st, Daneshjoo Blvd, Velenjak Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arista Shojaedin
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Yaman st, Daneshjoo Blvd, Velenjak Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
dr.shojaedin@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
laser application in medical sciences research center
Full name of responsible person
Zahra Razzaghi
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Shahrdari st, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Laser application in medical sciences research center
Full name of responsible person
Zahra Razzaghi
Position
Research Director
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Shahrdari st, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@sbmu.ac.ir
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
There is no more information
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
No - There is not 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
Not applicable
Title and more details about the data/document
data of Laser acupuncture in the treatment of depression
When the data will become available and for how long
from 2018
To whom data/document is available
researcher
Under which criteria data/document could be used
proposal presentation
From where data/document is obtainable
laser application in medical sciences research center
What processes are involved for a request to access data/document
Submit a proposal
Approval the proposal
Receive data