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IRCT20200122046228N1 IRCT 2020-10-28 Babol University of Medical Sciences The effect of computerized stress inoculation therapy (SIT) vs Part-time face-to-face SIT on anxiety , depression , and stress in pregnant women Comparison of effectiveness of computerized stress inoculation therapy (SIT) with Part-time face-to-face SIT in improvement of symptoms of anxiety, depression and stress in pregnant women with psychological distress 2020-10-31 anticipated 96 Complete https://irct.ir/trial/50493 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After checking inclusion and exclusion criteria, participants are allocate randomly into two groups by permuted block randomization method. The block size is 4 and by using the statistical software, 4 part blocks will be produced 24 times. Due to the fact that sampling is done in two centers, two samples of 96-list will be produced. Using this randomly generated list, participants are divided into two groups of 48 people. N/A Anxiety, depression, and stress. Intervention 1: Intervention group 1: The participants in this group at 14 to 34 weeks of pregnancy in addition to receiving prenatal care, receive computerized Stress Inoculation Therapy (SIT), 6 session , 60 minutes, once a week. Content of SIT: Session 1: Introducing and explaining the goals, describing the symptoms and their effects on mother and baby, conceptualizing the problem, explaining how this method reduces distress and anxiety. Session 2: Teaching body relaxation and continuing these exercises at home in Intervals between sessions, Session 3: Relaxing the body, challenging stressful thoughts, learning to talk to yourself and identifying the role of negative thoughts in creating these feelings, assign homework and practice body relaxation at home. Session 4: Body relaxation, teaching problem solving skills, assigning tasks, and practicing body relaxation at home, Session 5: Relaxation of the body, training techniques of concentration and distraction of the mind, away from unsolvable stressful issues, assigning homework and practicing body relaxation at home, Session 6: Practicing the skills learned in previous sessions in the training session and then gradually in real life events, especially in stressful situations. Intervention 2: Intervention group 2: The participants in this group at 14 to 34 weeks of pregnancy in addition to receiving prenatal care, receive individually Part-time face-to-face stress inoculation therapy, 6 sessions, 60 minutes, once a week. They receive treatment sessions with 3 face-to-face sessions and 3 computer sessions as one in between. Content and duration of treatment for both groups is similar, 6 sessions, once a week for 60 minutes. 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 There is no more information
public Fatemeh Nasiri- Amiri
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0597 nasiri_fa@yahoo.com Babol University of Medical Sciences scientific Fatemeh Nasiri- Amiri
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0597 nasiri_fa@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study Being in the 14th-32nd week of pregnancy No current psychotherapy services Lack of a history of psychiatric disorder At least a third year of middle school Internet access and the ability to use of computer 18 years no limit Female People with mental disabilities Severe psychiatric disorders such as Psychotic disorder, Bipolar disorder, Suicide risk, Drug abuse F41.2 Mixed anxiety and depressive disorder Treatment - Other Treatment - Other Intervention group 1: The participants in this group at 14 to 34 weeks of pregnancy in addition to receiving prenatal care, receive computerized Stress Inoculation Therapy (SIT), 6 session , 60 minutes, once a week. Content of SIT: Session 1: Introducing and explaining the goals, describing the symptoms and their effects on mother and baby, conceptualizing the problem, explaining how this method reduces distress and anxiety. Session 2: Teaching body relaxation and continuing these exercises at home in Intervals between sessions, Session 3: Relaxing the body, challenging stressful thoughts, learning to talk to yourself and identifying the role of negative thoughts in creating these feelings, assign homework and practice body relaxation at home. Session 4: Body relaxation, teaching problem solving skills, assigning tasks, and practicing body relaxation at home, Session 5: Relaxation of the body, training techniques of concentration and distraction of the mind, away from unsolvable stressful issues, assigning homework and practicing body relaxation at home, Session 6: Practicing the skills learned in previous sessions in the training session and then gradually in real life events, especially in stressful situations Intervention group 2: The participants in this group at 14 to 34 weeks of pregnancy in addition to receiving prenatal care, receive individually Part-time face-to-face stress inoculation therapy, 6 sessions, 60 minutes, once a week. They receive treatment sessions with 3 face-to-face sessions and 3 computer sessions as one in between. Content and duration of treatment for both groups is similar, 6 sessions, once a week for 60 minutes. Anxiety, depression, somatization, pregnancy-specific stress. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Anxiety and depression and somatization with Brief Symptom Inventory–18 (BSI-18) pregnancy-specific stress questionnaire ( NuPDQ-17) for pregnancy-specific stress. General perceived stress. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Cohen General Perceived Stress Questionnaire (PSS-14). Babol University of Medical Sciences Approved 2020-08-23 Ethics Committee of Babol University of Medical Sciences Ganj Afrooz St., Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)