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
-
-
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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
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