The primary purpose of this article is to assess and compare the effectiveness of Melatonin , CBT,TDCS in improving sleep quality by PSQI questionnaire
Design
This is a single-blind randomized clinical trial with parallel and control group of 176 soldiers who have sleep disorder , randomly assigned to 4 control groups, drug therapy, CBT and TDCS with excel .
Settings and conduct
PSQI questionnaires will be distributed at Dezhban training center in Kahrizak. Then soldiers who have sleep disorder(PSQI score more than 6) will be separated and subjected to clinical examination and randomly assigned to 4 groups. These procedures will be done at the psychology clinic of Imam Reza Hospital. Then PSQI scores will be reassessed after treatments.
Participants will be informed they would receive one of several possible treatments for sleep disorders without knowing the specific type. Specific information about the allocation is kept private.
Participants/Inclusion and exclusion criteria
the age group of 18-45
No history of psychiatric disorders and underlying disease
have at least 4 months of service left
having sleep disorder(PSQI score more than 6)
Intervention groups
1.CBT group:
The American CBTIM protocol is used for behavioral therapy, it consists of 6 sessions of 90 minutes and the patient is taught the sleep basics and sleep schedules, sleep hygiene and stress management
2.Melatonin group:
we will administer 3 mg of fast-released Melatonin 60 minutes prior to sleep for 4 weeks
3.TDCS group:
A 2mA direct constant electromagnetic current 20 minutes will be applied for awake patients in 4 sessions within two weeks
4.Control group:
They will be followed up for 1 month then the PSQI score will be reassessed. after trial one of these treatment will be administer for them based on their intentions.
Main outcome variables
PSQI score before treatment ;PSQI score after treatment; age; education
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240713062422N1
Registration date:2024-07-19, 1403/04/29
Registration timing:registered_while_recruiting
Last update:2024-07-19, 1403/04/29
Update count:0
Registration date
2024-07-19, 1403/04/29
Registrant information
Name
Alireza Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4412 3226
Email address
alisheikholislami@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-18, 1403/04/28
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Screening and treatment(TDCS,CBT,Drug therapy) of sleep disorders in AJA soldiers
Public title
Screening and treatment of sleep disorders in AJA soldiers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the age group of 18-45
No history of psychiatric disorders and underlying disease
have at least 4 months of service left
having sleep disorder(PSQI score more than 6)
Exclusion criteria:
history of psychiatric disorders and underlying disease
have at least 4 months of service left
unwillingness of the person to participate in the study
age more than 45 or under 18
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomly divided into 4 groups .Microsoft Office Excel was used to generate unique random codes which were then allocated to each individual patient. Specific information about the allocation was kept private by placing it in sealed, opaque envelopes and was only disclosed after the trial concluded. The envelopes and randomization will be done by a person not involved in the study to maintain allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were informed that they would receive one of several possible treatments for sleep disorders without knowing the specific type. health providers are not aware of other groups. Specific information about the allocation was kept private by placing it in sealed, opaque envelopes and was only disclosed after the trial concluded. Various people were responsible for carrying out randomizations, administering treatments, entering data, and performing statistical analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
AJA university, Etemad Zade street, west Fatemi street,Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.AJAUMS.REC.1402.239
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
The Pittsburgh Sleep Quality Index (PSQI) questionnaire score(from 21) will be calculated.those who have PSQI score more than 6 will enter the trial .and after completion of the treatment it will be reassessed .
Timepoint
Before treatment and After treatment(1 month later)
Method of measurement
The Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: CBT group: The American CBTIM protocol is used for behavioral therapy, it consists of 6 sessions of 90 minutes and the patient is taught the sleep basics and sleep schedules, sleep hygiene and stress management
Category
Behavior
2
Description
Intervention group: Melatonin group: we will administer 3 mg of fast-released Melatonin 60 minutes prior to sleep for 4 weeks.
Category
Treatment - Drugs
3
Description
Intervention group: TDCS group :A 2mA direct constant current with 30s rise and fall and duration 20 minutes will be applied for awake patients in 4 sessions within two weeks. TDCS will be applied by a battery-powered microprocessor-controlled constant current stimulator (Neurostim 2) delivered through two sponge electrodes with surface area 25 cm2 humidified with a saline solution. The anode and cathode electrodes will be placed on left and right DLPFC(dorsolateral prefrontal cortex) respectively, F3 and F4 in International 10-20 system .
Category
Treatment - Other
4
Description
Control group: They will be followed up for 1 month then the PSQI score will be reassessed. after trial one of these treatment will be administer for them based on their intentions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Alireza Hashemi
Street address
Imam Reza hospital-Etemad Zade street-Fatemi street
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
alireza.ha96@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Mosaed
Street address
AJA university, Etemad Zade street, west Fatemi street,Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
reza.mosaed@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zoshk
Position
Assistant Professor of Pediatrics
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
AJA university, Etemad Zade street, west Fatemi street,Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
dr.yousefi.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Alireza Hashemi
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
AJA university, Etemad Zade street, west Fatemi street,Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
alireza.ha96@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zoshk
Position
Assistant Professor of Pediatrics
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
AJA university, Etemad Zade street, west Fatemi street,Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
dr.yousefi.md@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
Not applicable
Title and more details about the data/document
Data is available anonymously
When the data will become available and for how long
6 month after publication
To whom data/document is available
The data is available for academic researchers
Under which criteria data/document could be used
Data are available for research purpose
From where data/document is obtainable
Aja university of medical science -Dr mojtaba Yousefi Zoshk
dr.yousefi.md@gmail.com
What processes are involved for a request to access data/document
data are available through research center of AJA university of medical science from Dr Mojtaba Yousefi Zoshk.it may take one month