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IRCT20231220060478N1 IRCT 2023-12-26 Islamic Azad University Investigating the effect of Cognitive behavioral therapy and Neurofeedback in pregnant women on Worry, Depression, Anxiety, Stress during pregnancy and postpartum Depression Investigating the effect of Cognitive behavioral therapy and Neurofeedback in pregnant women on perinatal Concern, Depression, Anxiety, Stress and postpartum Depression 2024-02-20 anticipated 90 Complete https://irct.ir/trial/74551 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This research will be of experimental type in the form of pre-test-post-test with a control group. The statistical population of this research consists of all pregnant women referring to health centers in Ardabil city.11-question demographic questionnaire, Pregnancy Distres Questionnaire (PDQ), DASS 21 (Depression, Anxiety, Stress Scale) and Beck's Standard Depression Questionnaire will be administered as a pre-test for the participants in this study.In this study, those who have mild and moderate concern, depression, stress and anxiety will be randomly assigned to two experimental groups, Cognitive behavioral therapy (and midwife support) and Neurofeedback, and a control group (30 people in each group). After completing the therapeutic interventions, all the participants will be administered the questionnaires and the data will be collected.To evaluate postpartum depression, in the research samples, the Edinburgh postpartum depression questionnaire will be administered to all groups on days 10-15 and 30-42 days after delivery, who refer to health centers for mental health screening, Randomization description: In this study, those with mild and moderate depression will be treated in two groups of Cognitive behavioral therapy (and midwife support) and Neurofeedback and a random control group. The samples will be determined using the block random sampling method (The number of samples allocated to each of the studied groups(each group 30 people) will be equal). In this way, we will create blocks of three ABC using random numbers generated from 1 to 90 by the software and randomly divide the random numbers into three equal groups and select the groups based on the way ABC is arranged and will study it. Group A will be treated with Cognitive behavioral therapy (and midwife support), group B will be treated with Neurofeedback. Group C, as a Control group, will not receive any intervention except routine prenatal care. N/A Perinatal worry, depression, anxiety, stress and postpartum depression. Intervention 1: In this study, those with mild and moderate concern, depression, stress and anxiety will be randomly treated in two experimental groups, Cognitive behavioral therapy (and midwife support) and Neurofeedback and a control group. First intervention group: For the first experimental group, Cognitive behavioral therapy (and midwife support) will be used by a psychologist and a midwife. Cognitive behavioral therapy (and midwife support) is performed for each person from the sixteenth week of pregnancy for 15 sessions. The sessions are 50 minutes each week and will continue until the 30th week of pregnancy. The second intervention group: For the second experimental group, Neurofeedback treatment will be performed by a psychologist. Each person will receive 30 Neurofeedback sessions from the 16th week of pregnancy, 2 sessions a week, each session lasts 40 minutes and will continue until the 30th week of pregnancy. Intervention 2: Control group: The control group will receive only usual pregnancy care and no intervention or treatment. 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 No more information is needed
public Roya Motavalli
No. 50, Janbazan 4., Hafez Street
Ardabil Iran (Islamic Republic of) 5615748911 +98 45 3371 1060 Mrmotavalli@yahoo.com Islamic Azad University scientific Roya Motavalli
No. 50, Janbazan 4., Hafez Street
Ardabil Iran (Islamic Republic of) 5615748911 +98 45 3371 1060 Mrmotavalli@yahoo.com Islamic Azad University Iran (Islamic Republic of) Primiparous pregnant women Those who do not have communication problems Those who do not have a high-risk pregnancy (multiple pregnancy, pregnancy, premature birth, preeclampsia, etc.) Those who volunteer to participate in the research Those who have not received psychological treatment and support in the last 6 months Those who did not receive neurofeedback treatment before Those who have undergone the second mental health screening in the 16-20 week of pregnancy 18 years 45 years Female Those who have severe worry, depression, stress and anxiety and need drug treatment F41.2 Mixed anxiety and depressive disorder Treatment - Other Diagnosis In this study, those with mild and moderate concern, depression, stress and anxiety will be randomly treated in two experimental groups, Cognitive behavioral therapy (and midwife support) and Neurofeedback and a control group. First intervention group: For the first experimental group, Cognitive behavioral therapy (and midwife support) will be used by a psychologist and a midwife. Cognitive behavioral therapy (and midwife support) is performed for each person from the sixteenth week of pregnancy for 15 sessions. The sessions are 50 minutes each week and will continue until the 30th week of pregnancy. The second intervention group: For the second experimental group, Neurofeedback treatment will be performed by a psychologist. Each person will receive 30 Neurofeedback sessions from the 16th week of pregnancy, 2 sessions a week, each session lasts 40 minutes and will continue until the 30th week of pregnancy. Control group: The control group will receive only usual pregnancy care and no intervention or treatment. Pregnancy Distress score: In the pregnancy Distress questionnaire, the highest score that can be obtained from the questionnaire is 48 and the lowest score is zero. A high score in the questionnaire shows that worry is high during pregnancy, if the score is low and close to zero, it means that worry is low during this period. Timepoint: Before starting therapeutic interventions in pregnant women at 16-20 weeks of pregnancy, a pre-test will be conducted using a pregnancy distress questionnaire, and in research samples with mild and moderate concern, therapeutic interventions will continue until the 30th week of pregnancy and a post-test after treatment. , will be used to measure the investigated variable. Method of measurement: Pregnancy Distress Questionnaire(PDQ). Depression score: In the DASS 21 questionnaire, scores between 0-4 are normal, scores between 5-6 are mild depression, scores 7-10 are moderate depression, scores 11-13 are severe depression, and scores 14 and above are considered very severe depression.In the Beck depression questionnaire, a score between 0 and 21 indicates mild depression, a score between 21 and 31 indicates moderate depression, and a score above 31 indicates severe depression. Timepoint: Before starting therapeutic interventions in pregnant women at 16-20 weeks of pregnancy, a pre-test will be conducted using the DASS 21 questionnaire and the Beck depression questionnaire, and after diagnosis in the research samples with mild and moderate depression, the therapeutic interventions will continue until the 30th week of pregnancy. After the treatment, the post-test will be used to measure the studied variables. Method of measurement: DASS 21 questionnaire and Beck depression questionnaire. Postpartum depression score: In the Edinburgh Postpartum Depression Questionnaire, a score below 10 means that the person is healthy, a score of 10 or more means depression. Question number ten needs attention if the answer is yes, there is a possibility of mother's suicide. Timepoint: To evaluate postpartum depression on days 10-15 and 30-42 days after delivery, the test will be performed with a questionnaire. Method of measurement: Edinburgh Postpartum Depression Questionnaire. Anxiety score: In the DASS 21 questionnaire, scores of 0-3 are normal anxiety, scores of 4-5 are mild anxiety, scores of 6-7 are moderate anxiety, scores of 8-9 are severe, and scores of 10 and above are considered very severe anxiety. Timepoint: Before starting therapeutic interventions in pregnant women at 16-20 weeks of pregnancy, a pre-test will be conducted using the DASS 21 questionnaire, and after diagnosis in research samples with mild and moderate anxiety, therapeutic interventions will continue until 30 weeks of pregnancy. After the treatment, the post-test will be used to measure the studied variables. Method of measurement: DASS 21 questionnaire. Stress score: In the DASS 21 questionnaire, scores of 0-7 are normal stress, scores of 8-9 are mild stress, scores of 10-12 are moderate stress, scores of 13-16 are severe stress, and scores of 17 and above are considered very severe stress. Timepoint: Before starting therapeutic interventions in pregnant women at 16-20 weeks of pregnancy, a pre-test will be conducted using the DASS 21 questionnaire, and after diagnosis in research samples with mild and moderate stress, therapeutic interventions will continue until the 30th week of pregnancy. After the treatment, the post-test will be used to measure the studied variables. Method of measurement: DASS 21 questionnaire. Reducing the score of worry. Timepoint: The level of worry will be measured 15 sessions after cognitive behavioral therapy (and midwife support) and 30 sessions after neurofeedback treatment and at 34 weeks of pregnancy. Method of measurement: Pregnancy Distres Questionnaire (PDQ). Reducing the score of stress. Timepoint: The level of stress will be measured 15 sessions after cognitive behavioral therapy (and midwife support) and 30 sessions after neurofeedback therapy and at the 34th week of pregnancy. Method of measurement: DASS 21 Questionnaire. Reducing the score of anxiety. Timepoint: The level of anxiety will be measured 15 sessions after cognitive behavioral therapy (and midwife support) and 30 sessions after neurofeedback therapy and at the 34th week of pregnancy. Method of measurement: DASS 21 Questionnaire. Reducing the score of depression. Timepoint: The level of depression will be measured 15 sessions after cognitive behavioral therapy (and midwife support) and 30 sessions after neurofeedback therapy and at the 34th week of pregnancy. Method of measurement: DASS 21 Questionnaire and Beck's Standard Depression Questionnaire. Reducing postpartum depression. Timepoint: Postpartum depression will be measured on days 10-15 and 30-42 days after delivery. Method of measurement: Edinburgh Postpartum Depression Questionnaire. Islamic Azad University Approved 2023-11-28 Research Ethics Committees of Islamic Azad University-Ardabil Branch Islamic Azad University, Ardabil Branch, Basij Square Ardabil Ardabil Iran (Islamic Republic of)