Evaluation of effectiveness of Sertraline and supportive psychotherapy on anxiety and depression level of Leukemia patient referring to clinic of Ali-ibn-Abitaleb Hospital in Zahedan
The comparison between the effect of Sertraline and supportive psychotherapy on the anxiety and depression of the patients with definite diagnosis of leukemia
Design
Two arm parallel groups randomized trial without blindness
Settings and conduct
This study will be performed in Imam Ali clinic at Zahedan. 60 patients who were administered with the definite diagnosis of leukemia by the specialist and age domain of 18 to 64 years old will be included in our study. one group will be treated by the supportive psychotherapy session for 6 weeks and the other group will be treated by Sertraline. the rate of anxiety and depression will be evaluated y the anxiety and depression questionnaire of Hamilton at the beginning of the treatment, first, third, sixth week after the treatment.
Participants/Inclusion and exclusion criteria
The patients with the definite diagnosis of leukemia and the age domain of 18 to 64 years without any history of previous medical and psychological problems will be included to our study and the patients with the allergy to Sertraline or dissatisfaction will be excluded from the study.
Intervention groups
The first intervention group includes 30 patients who will be treated by supportive psychotherapy session with the duration of each about 90 minutes for 6 weeks and the second intervention group will be treated by the first therapeutic dose of 50 mg of Sertralin which will be increased to 200mg in two weeks due to the lack of response
Main outcome variables
Age, gender, rate of anxiety, rate of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180425039418N4
Registration date:2019-01-25, 1397/11/05
Registration timing:registered_while_recruiting
Last update:2019-01-25, 1397/11/05
Update count:0
Registration date
2019-01-25, 1397/11/05
Registrant information
Name
mohammad Ghena'at Pisheh Sanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 1227
Email address
mohammad.ghenaat71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of Sertraline and supportive psychotherapy on anxiety and depression level of Leukemia patient referring to clinic of Ali-ibn-Abitaleb Hospital in Zahedan
Public title
Evaluation of effectiveness of Sertraline and supportive psychotherapy on anxiety and depression level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of patients is between 18 to 64 years old
The patients were administered with the definite diagnosis of leukemia by the specialist
All the patients should fill up the written consent and give it to the researchers for attending the study
The education level of the patients is at least from elementary
The patients don't have any history of other medical or psychological disorders
The patients don't have any history of drug consumption except smoking
Exclusion criteria:
The patient doesn't intend to attend the study
The patient has a history of allergy to Sertraline
Age
From 18 years old to 64 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization that the patients with the definite diagnosis of leukemia who referred to the clinic of Ali-Ibn-Abitaleb Hospital, will be classified into two groups each with 30 people by the
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr.Hesabi Square, Campus of Medical Scineces
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.ZAUMS.REC.1397.326
Health conditions studied
1
Description of health condition studied
Major depression disorders
ICD-10 code
F33.9
ICD-10 code description
Major depressive disorder, Recurrent, Unspecified
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
The Scale of Questionnaire on Hamilton's Depression and Anxiety
Timepoint
At the time of beginning of therapies, 1 week after beginning the therapies , 3 weeks after beginning the therapies , and 6 weeks after beginning the therapies
Method of measurement
The Scale of Questionnaire on Hamilton's Depression and Anxiety
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In this group, 30 patients with the definite diagnosis of leukemia with the age range of 18 to 64 years old at the clinic of Ali-ibn-Abitaleb Hospital in Zahedan, will treated with the administration of the first dose of 50 mg Sertraline. However, the dosage will be increased to 200mg daily due to the lack of response
Category
Treatment - Drugs
2
Description
Second intervention group: In this group, 30 patients with definite diagnosis of Parkinson disease and age domain of 18 to 64 years old at the clinic of Ali-ibn-Abitaleb Hospital in Zahedan, will be treated by 6 weeks supportive psychotherapy in which each session has the duration of 90 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ibn-Abitaleb Hospital (as)
Full name of responsible person
Amirali Fani
Street address
Salamat Blvd, Persian Gulf Expressway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
it@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Hashemi
Street address
Dr.Hesabi square , Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Amirali Fani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Dr. Hesabi Square, Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
mohammad.ghenaat71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Amirali Fani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Dr.Hesabi Square, Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
mohammad.ghenaat71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Amirali Fani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Dr.Hesabi Square, Medical Sciences Campus
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
mohammad.ghenaat71@gmail.com
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