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IRCT20171105037241N2 IRCT 2017-12-26 Zahedan University of Medical Sciences Comparison of therapeutic effect of sertraline and supportive psychotherapy in comparison with placebo in coronary heart disease patients with mild to moderate depression Comparison of therapeutic effect of sertraline and supportive psychotherapy in comparison with placebo in coronary heart disease patients with mild to moderate depression 2017-12-22 anticipated 90 Complete https://irct.ir/trial/27596 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Easy and accessible and assigned to groups based on randomly clustered blocks, Blinding description: The participants are kept blind to the type of drug they receive. N/A Condition 1: Depression. Condition 2: Mild Depression. Condition 3: Moderate depression. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control groupIn : the placebo group, the sertraline placebo will also be used, which is used in this study of vitamin C. Undecided - It is not yet known if there will be a plan to make this available
public Mohammadislam Sourizahi
Zahedan, DrHesabi square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5715 dr.sourizahi58@zaums.ac.ir Zahedan University of Medical Sciences scientific Mohammadislam Sourizahi
Zahedan, DrHesabi square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5715 dr.sourizahi58@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) coronary heart disease mild to moderate depression No serious medical illness Non-use of psychiatric drugs no limit no limit Both Heart medications affecting the mood f32.0 f32.0 f32.1 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 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. 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. Behavior Treatment - Drugs Placebo 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. 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. Control groupIn : the placebo group, the sertraline placebo will also be used, which is used in this study of vitamin C Depression level in patients with coronary artery disease. Timepoint: first, third, sixth weeks. Method of measurement: Hamilton Depression Survey Questionnaire. Zahedan University of Medical Sciences Approved 2017-09-24 Ethics committe of Zahedan University of Medical Sciences DrHesabi Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)