Comparison of therapeutic effect of sertraline and supportive psychotherapy in comparison with placebo in coronary heart disease patients with mild to moderate depression
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General information
IRCT20171105037241N1
IRCT20171105037241N2
IRCT20171105037241N1IRCT20171105037241N2
2017-12-26, 1396/10/05
2017-12-26, 1396/10/05
2017-12-26 12:2829:5704
Protocol summary
Study aim
Determination and comparison of sertraline and supportive treatment and placebo on depression in coronary artery disease patients
Comparison of mean depression scores in three treatment groups
Design
In this study, 90 patients with coronary artery disease who are suffering from depression and who have criteria for entering the study are selected. Participants are randomly divided into three groups and each participant will be assigned a code.
Settings and conduct
This study is done in patients with coronary artery disease with depression referring to Ali ibn Abitalib Hospital in Zahedan. After entering the study, patients randomly divided into three groups receiving sertraline, a group receiving psychotherapy and a placebo group. They will be.In the group receiving sertraline, the drug is given to patients with a dose of 50 mg, and within a week it will reach 150 to 200 mg. The placebo group will also use the sertraline placenta. The psychotherapy recipient group will be interviewed and supportive once a week for 6 weeks and 45 minutes each.The homogeneity of the age distribution of patients is assessed in three groups
To determine the level of depression in patients, a questionnaire was completed for each patient, and then the level of depression in the first, third and sixth weeks was re-evaluated using the same questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having Heart Disease,
Non-use of psychiatric drugs,
Mild to moderate depression
No other serious medical illness
Exclusion criteria:
Taking heart medications affecting the mood
Serious medical illness
Intervention groups
In this study, the effectiveness of psychotherapy in comparison with sertraline and placebo in the treatment of depression in patients with coronary artery disease is studied.
Main outcome variables
depression level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171105037241N2
Registration date:2017-12-26, 1396/10/05
Registration timing:registered_while_recruiting
Last update:2017-12-26, 1396/10/05
Update count:1
Registration date
2017-12-26, 1396/10/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 549 2771
Email address
dr.sourizahi58@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of sertraline and supportive psychotherapy in comparison with placebo in coronary heart disease patients with mild to moderate depression
Public title
Comparison of therapeutic effect of sertraline and supportive psychotherapy in comparison with placebo in coronary heart disease patients with mild to moderate depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
coronary heart disease
mild to moderate depression
No serious medical illness
Non-use of psychiatric drugs
Exclusion criteria:
Heart medications affecting the mood
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Easy and accessible and assigned to groups based on randomly clustered blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are kept blind to the type of drug they receive
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Zahedan University of Medical Sciences
Street address
DrHesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.ZAUMS.REC.1396.158
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
f32.0
ICD-10 code description
F32 Depressive episode In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reduction of energy, and decrease in activity. Capacity for enjoyment, interest, and concentration is reduced, and marked tire
2
Description of health condition studied
Mild Depression
ICD-10 code
f32.0
ICD-10 code description
F32.0 Mild depressive episode Two or three of the above symptoms are usually present. The patient is usually distressed by these but will probably be able to continue with most activities.
3
Description of health condition studied
Moderate depression
ICD-10 code
f32.1
ICD-10 code description
F32.1 Moderate depressive episode Four or more of the above symptoms are usually present and the patient is likely to have great difficulty in continuing with ordinary activities.
Primary outcomes
1
Description
Depression level in patients with coronary artery disease
Timepoint
first, third, sixth weeks
Method of measurement
Hamilton Depression Survey Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, cognitive-behavioral interventions are performed to improve depression in patients with coronary artery disease. These interventions will be conducted in seven sessions. Session 1: Patients' experiences with depression in response to the diagnosis of heart disease are presented and discussed in their experimental form.. The purpose of this section is to provide a formulation of the psychological problems of patients. According to the experiences of patients, the goals of the sessions and educational needs are determined, and the participants arrive at an understanding of the cognitive-behavioral therapy program.Significantly, at this time, avoidance of thoughts and feelings associated with the disease may occur at the time, most of which are due to admissions and side effects of the treatment. The second component of the first session is to introduce references to controlled diaphragmatic breathing and gradual muscle relaxation training. A training session is provided for both techniques.Second session: Five next weekly sessions begin with a review of homework and examine any problems that patients have encountered. The second session involves exposure and cognitive therapy. Cognitive therapy is introduced at the second session to allow patients to use this strategy during treatment, as well as during preparation and during exercise training sessions.Although cognitive-behavioral therapy can not recognize the prognosis of an illness, the Imam can help the patient better deal with the disease. How to manage their painful prejudices and assumptions will help patients to improve their quality of life somewhat. .Behavioral activation goals: a) Helping the patient to plan for the weekly without pressure feelings as well as family and work commitments; b) engaging in at least one meaningful activity for the patient for at least 15-20 minutes per day.Patients undergoing treatment are more likely to find a better chance to adapt to the routine of the hospital. Session 5: The main part of Session 5 is the continued prolonged imaginary endeavor, followed by an inference with a cognitive reconstruction of cognitive therapy.For these clients, emphasis on the fifth session focuses on cognitive reconstruction. As a result of this meeting, all users will be encouraged to continue to practice the strategies trained in this program. Session Six: Session Six is the last session of the week. When reviewing the homework, each key component is also reviewed in the treatment plan. Clients are encouraged to continue these strategies until the end of the regimen.The post-treatment period is a basic period of adaptation and an attempt to return to normal before the diagnosis of the disease. Hence, recurrence prevention strategies are provided at session 6. Particularly, the goal of this section is to help the patient to take into account future experiences and challenges that they may encounter, and that the patient is equipped with facilities to overcome these problems.The patient should practice cognitive-behavioral therapy skills to neutralize disastrous thoughts and beliefs and be able to adapt to this uncertainty. The seventh session of this support session will be held one month after the end of the sixth session. The purpose of the study is to investigate the progress of references in the application of the behavioral cognitive skills of the past four weeks.Also, checking if the patient has encountered a new problem, or any obstacle to the implementation of strategies to prevent recurrence.
Category
Behavior
2
Description
Intervention group :Sertraline receiving group: In this group, sertraline tablets are given to patients 50 mg orally once a day and will receive 150 to 200 mg per week.
Category
Treatment - Drugs
3
Description
Control groupIn : the placebo group, the sertraline placebo will also be used, which is used in this study of vitamin C
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ebn-Abitaleb hospital
Full name of responsible person
Mohammadislam Sourizahi
Street address
Khalijfars Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5575
Fax
+98 54 3329 5563
Email
dr.sourizahi58@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noormohammad Bakhshani
Street address
DrHesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
dr.sourizahi58@zaums.ac.ir
Grant name
Thesis cost
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
Mohammadislam Sourizahi
Position
psychiatric assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Zahedan, DrHesabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Fax
Email
dr.sourizahi58@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammadislam Sourizahi
Position
psychiatric assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Zahedan, DrHesabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Fax
Email
dr.sourizahi58@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammadislam Sourizahi
Position
psychiatric assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Zahedan, DrHesabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 915 549 2771
Fax
Email
dr.sourizahi58@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available