Therapeutic effects of low-level laser therapy (LLLT) in reducing symptoms of depression and anxiety in bipolar patients
Design
A clinical trial with a control group with two-way randomized parallel groups on 40 patients. Block randomization is used for randomization.
Settings and conduct
The patients referred to the psychiatry department of Taleghani Hospital will be included in the study after obtaining the consent form from both the patient and the family. The psychologist (non-blind) will take their information based on age, gender, level of education, marital status, previous hospitalization, and duration of the disease, the relevant questionnaires note the presentation of symptoms and the level of depression. They are homogeneously divided into two treatment and control groups. Finally, the information obtained from the questionnaires is given to the researcher (blind) to be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients under the treatment of bipolar depression admitted to the psychiatric ward, aged over 18 years. Exclusion criteria: patients with a history of neurological disease, pregnancy, or acute and chronic physical illness; those receiving antidepressant treatment ECT.
Intervention groups
The therapeutic intervention group underwent laser therapy as an auxiliary treatment in the first two weeks of hospitalization every week. They have 5 sessions . the control group will be treated with a zero-intensity device in the first two weeks of hospitalization. The level of depression and anxiety is evaluated again by a questionnaire at the end of the treatment and one month after the last treatment at the clinic and the before and after results are compared between the 2 groups.
Main outcome variables
Anxiety, depression (Hamilton's questionnaire)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220614055175N1
Registration date:2022-12-12, 1401/09/21
Registration timing:registered_while_recruiting
Last update:2022-12-12, 1401/09/21
Update count:1
Registration date
2022-12-12, 1401/09/21
Registrant information
Name
Somayeh Jarrahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 7176
Email address
jarrahi1364@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of low-level laser therapy in reducing Depression and Anxiety symptoms in bipolar patient treatment
Public title
Therapeutic effects of low-level laser therapy in reducing Depression and Anxiety symptoms in bipolar patient treatment Compared with the control group
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients treated for bipolar depression admitted to the psychiatric ward.
Age over 18 years.
Both genders
Exclusion criteria:
Patients with a history of neurological diseases such as epilepsy and other neurological disorders such as parkinsonism, traumatic brain injury, stroke
pregnancy
Acute and chronic physical illness
Cases receiving antidepressant treatment or ECT (convulsive therapy with electroshock).
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is done as block randomization for 40 people. If A is for treatment and B is for control, first we define 6 combinations with equal allocation as follows:
1=(ABBA)
2=(ABAB)
3=(AABB)
4=(BABA)
5=(BBAA)
6=(BAAB)
Then, using the table of random numbers from 1 to 6, ten numbers are selected and based on the numbers selected from the list above, we determine the order of the patient or the control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each patient is assigned a code at the beginning of the study, which will be known by that code until the end of the study. This study was conducted in a double-blind manner, so that the patients, doctors, and clinical caregivers and the data analyzer are not aware of the groupings and only the third party, who is the psychologist of the department It will group people and evaluate relevant questionnaires before and after treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Taleghani Hospital,kodakyar Street , Student Blvd ,Valenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
IR.SBMU.MSP.REC.1401.349
Health conditions studied
1
Description of health condition studied
bipolar disorder
ICD-10 code
F31.4
ICD-10 code description
Bipolar disorder, current episode depressed, severe, without psychotic features
Primary outcomes
1
Description
Depression
Timepoint
Before and after treatment
Method of measurement
HAMILTON depression questionnaire
2
Description
Anxiety
Timepoint
Before and after treatment
Method of measurement
Hamilton anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:This group will be formed by patients who receive PBM (photobiomudulation) as an auxiliary treatment in the first two weeks of hospitalization, and their information is based on age, sex, level of education, marital status, previous hospitalization and the duration of the onset of the disease. The symptoms and level of depression are noted by the relevant questionnaires and they are treated with low power laser for 2 weeks and 5 sessions every week. The level of depression and anxiety is again measured by the questionnaire at the end of the treatment and one month after the last treatment at the evaluation clinic and the before and after results are compared between the 2 groups. They receive antipsychotic drugs, they enter the treatment cycle and their dosage is determined.
Category
Treatment - Devices
2
Description
Control group:The people of the second group will be selected as the same control group as the first group. The level of depression and anxiety is again measured by the questionnaire at the end of the treatment and one month after the last treatment at the evaluation clinic and the before and after results are compared between the 2 groups. They receive antipsychotics, they enter the treatment cycle, and their equivalent dose is determined, and a person with the same amount of medicine is placed in the control group.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
علی خردمند
Street address
Taleghani Hospital,kodakyar Street , Student Blvd ,Valenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
taleghanihospital@sbmu.ac.ir
Web page address
http://taleghani.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
افشین زرقی
Street address
Student Blvd ,Valenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
Web page address
https://old.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
Somayeh Jarrahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Sarshar dormitory number 12,sarshar dead end alley,Valiasr street
City
Tehran
Province
Tehran
Postal code
1961835484
Phone
+98 21 2272 1367
Email
jarrahi1364@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
علی خردمند
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Taleqani hospital, Student Blvd ,Valenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
dr.alikheradmand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Jarrahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Sarshar dormitory number 12,sarshar dead end alley,Valiasr street
City
Tehran
Province
Tehran
Postal code
1961835484
Phone
+98 21 2272 1367
Email
jarrahi1364@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 can potentially be shared after de-identifying individuals
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
All researchers working in academic and scientific institutions, doctors and pharmaceutical companies will be allowed to access the information
Under which criteria data/document could be used
The applicant can access the information after providing proof of identity
From where data/document is obtainable
Applicants can contact Dr. Somayeh Jarrahi by email to receive the desired documents or data.jarrahi1364@gmail.com
What processes are involved for a request to access data/document
The applicant can communicate with the researcher through email and receive the basic data after presenting the identity documents