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IRCT20210119050079N1 IRCT 2021-06-13 Kermanshah University of Medical Sciences Comparison of the effect of 8 weeks of physical activity and mindfulness-based stress reduction program on psychological factors, sleep quality and pattern in patients with major depression Comparison of the effect of 8 weeks of physical activity and mindfulness-based stress reduction program on psychological factors, sleep quality and pattern in patients with major depression (clinical trial study with a control group) 2021-07-23 anticipated 60 Complete https://irct.ir/trial/56552 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into four equal groups (1. physical activity, 2. mindfulness, 3. combination of physical activity and mindfulness and 4. control) based on a randomized ten-block design using random allocation software. To randomly assign 60 patients to the four groups, six different blocks of 10 different letters A and B and C and D, which indicate physical activity, mindfulness, combination of physical activity and mindfulness and control groups respectively, will be initially created. These blocks then will be numbered from one to ten. In the next step, each of these blocks will be randomly selected by performing lottery using 10 card with letters from 1 to 10 on them. Thus, in each lottery, by selecting a block, a combination of 6 letters of the letters A and B and C and D will be obtained. At the end of the 10 drawings, after selecting 10 blocks, a total of 60 letters A and B and C and D will be obtained. The resulting combination of letters A and B and C and D is single, and will be placed in 60 separate and sealed envelopes, respectively. following each patient recourse, an envelope will be opened to determine the group of that patient, Blinding description: Outcome examiners (people who distribute questionnaires among patients) are blind to the type of groups. 2 Major depressive disorder. Intervention 1: Intervention group: The group will receive aerobic exercise in two months. The exercises will include two parts: static aerobic exercise and dynamic aerobic exercise. In general, the exercises will consist of 4 main parts. 1) warm up; It will include stretching movements, hypothetical line movements, cross-arm movements, arm rotations, neck rotations, cross-leg movements, sit-ups, 2) static aerobic exercise; Includes climbers walking, Palank, Palank with knee touch, and ski movement. 3) Dynamic aerobic exercise; It will include jogging at 70% of your maximum heart rate. 4) cooling down; It will include stretching, cross-linking, sitting, lying down and cradle movement. Exercises are performed with behavioral techniques and with the guidance of sports instructors and in a modified manner in accordance with the physical fitness of patients. The intervention will done in 8 weeks and 2 sessions per week. Patients engage in aerobic exercise for 30 to 45 minutes per session. Intervention 2: Intervention group: The group will receive mindfulness based stress reduction program in two months. Mindfulness based stress reduction will done at 8 weeks and twice a week. The first week includes training and will discuss the MBSR and its potential for mental health. The second week is the stage of communication and conceptualization of mindfulness. The third week will include mindfulness training and dealing with obstacles. The fourth week of identifying values ​​is the distinction between value and purpose. The fifth week will be the practice of mindfulness and staying in the present. The sixth week will be devoted to cognitive, emotional and behavioral flexibility. The seventh week will be about creating a sense of acceptance and compassion in patients. Finally, in the eighth week, the composition and coherence of the components of mindfulness will be considered. Intervention 3: Intervention group: The group will receive combination of physical activity and mindfulness intervention in two months. Training on non-judgment and acceptance will be considered. Patients will learn to look at their goals and values without negative or positive judgments. Moreover, the physical activity will be considered as an training in the mindfulness intervention. In this way, the importance of physical activity as a factor in overcoming negative thoughts and reaching the present will be discussed. Patients will spend half of the treatment session on physical activity and the other half on the MBSR program. The intervention will done in 8 weeks and 2 sessions per week. Intervention 4: Control group: The group will receive Sertraline (Tolid Daro company) treatment in two months. Sertraline is prescribed at a dose of 50 to 200 mg per day as medication (control group). In addition, Patients are monitored by telephone twice a week in the control group. They are questioned about their physical and psychological condition. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Habibolah Khazaie
Sleep Disorders Research Center, Farabi Hospital, Doulatabad Blvd., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6719851151 +98 83 1824 9353 hakhazaie@gmail.com Kermanshah University of Medical Sciences scientific Habibolah Khazaie
Farabi Hospital, Sleep Disorders Research Center, Department of Psychiatry, Kermanshah University of Medical Sciences, Dolatabad Blvd, PO box: 6719851151, Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) : 6719851151 +98 83 1824 9353 hakhazaie@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Major depression disorder diagnosed by a psychiatrist Diagnosis of major depression disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition: DSM-5 and Beck questionnaire Have major depressive symptoms for at least 2 weeks no limit no limit Both Patients who are not agree to participate in the study will be excluded F32.2 Major depressive disorder, single episode, severe without psychotic features Behavior Behavior Behavior Treatment - Drugs Intervention group: The group will receive aerobic exercise in two months. The exercises will include two parts: static aerobic exercise and dynamic aerobic exercise. In general, the exercises will consist of 4 main parts. 1) warm up; It will include stretching movements, hypothetical line movements, cross-arm movements, arm rotations, neck rotations, cross-leg movements, sit-ups, 2) static aerobic exercise; Includes climbers walking, Palank, Palank with knee touch, and ski movement. 3) Dynamic aerobic exercise; It will include jogging at 70% of your maximum heart rate. 4) cooling down; It will include stretching, cross-linking, sitting, lying down and cradle movement. Exercises are performed with behavioral techniques and with the guidance of sports instructors and in a modified manner in accordance with the physical fitness of patients. The intervention will done in 8 weeks and 2 sessions per week. Patients engage in aerobic exercise for 30 to 45 minutes per session. Intervention group: The group will receive mindfulness based stress reduction program in two months. Mindfulness based stress reduction will done at 8 weeks and twice a week. The first week includes training and will discuss the MBSR and its potential for mental health. The second week is the stage of communication and conceptualization of mindfulness. The third week will include mindfulness training and dealing with obstacles. The fourth week of identifying values ​​is the distinction between value and purpose. The fifth week will be the practice of mindfulness and staying in the present. The sixth week will be devoted to cognitive, emotional and behavioral flexibility. The seventh week will be about creating a sense of acceptance and compassion in patients. Finally, in the eighth week, the composition and coherence of the components of mindfulness will be considered. Intervention group: The group will receive combination of physical activity and mindfulness intervention in two months. Training on non-judgment and acceptance will be considered. Patients will learn to look at their goals and values without negative or positive judgments. Moreover, the physical activity will be considered as an training in the mindfulness intervention. In this way, the importance of physical activity as a factor in overcoming negative thoughts and reaching the present will be discussed. Patients will spend half of the treatment session on physical activity and the other half on the MBSR program. The intervention will done in 8 weeks and 2 sessions per week. Control group: The group will receive Sertraline (Tolid Daro company) treatment in two months. Sertraline is prescribed at a dose of 50 to 200 mg per day as medication (control group). In addition, Patients are monitored by telephone twice a week in the control group. They are questioned about their physical and psychological condition. Symptoms of depression. Timepoint: before intervention- 8 weeks later- 4 weeks later. Method of measurement: Beck Questionnaire. Symptoms of anxiety. Timepoint: before intervention- 8 weeks later- 4 weeks later. Method of measurement: Beck Questionnaire. Perceived stress. Timepoint: before intervention- 8 weeks later- 4 weeks later. Method of measurement: Cohen Questionnaire. Emotion regulation. Timepoint: before intervention- 8 weeks later- 4 weeks later. Method of measurement: Emotion Regulation Problems Questionnaire. Sleep quality. Timepoint: before intervention- 8 weeks later- 4 weeks later. Method of measurement: Pittsburgh Questionnaire. Sleep pattern. Timepoint: before intervention- 8 weeks later- 4 weeks later. Method of measurement: Insomnia Severity Scale and sleep tables. Kermanshah University of Medical Sciences Approved 2021-05-15 Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)