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IRCT20110228005931N9 IRCT 2020-12-08 National Institute for Medical Research Development (NIMAD) Effectiveness of internet psychotherapy in reduction of anxiety/depression of infertile women Effect of internet-based cognitive behavioral therapy in reduction of anxiety/depression of infertile women 2020-12-05 anticipated 60 Complete https://irct.ir/trial/51994 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: A non-inferiority randomized controlled clinical trial with two parallel arms, 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 15 times. One samples of 60-list will be produced. Using this randomly generated list, participants are divided into two groups of 30 people. N/A Anxiety and depression. Intervention 1: Intervention group A: The participants in this group receive online cognitive behavioral therapy once a week, 8 session 50 minutes. Intervention 2: Intervention group B: Participants in this group receive individually face-to- face cognitive behavioral therapy, once a week 8 sessions 50 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 informatiom
public Dr. Farzan Kheyrkhah
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 47176-47745 +98 911 112 8368 drfarzankh@yahoo.com Babol University of Medical Sciences scientific Dr. Farzan Kheirkhah
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 47176-47745 +98 911 112 8368 drfarzankh@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Aged 19-45 years More than five years of education Based on Beck's questionnaire meeting the criteria for mild to moderate depression (between 14 to 49) Did not receive any medication or counseling Have access to computers and the Internet Have access to a telephone that is always able to respond 19 years 45 years Female Unwillingness to participate in the study Severe depression The existence of suicidal ideation F41.2 mixed anxiety and depressive disorder Treatment - Other Treatment - Other Intervention group A: The participants in this group receive online cognitive behavioral therapy once a week, 8 session 50 minutes. Intervention group B: Participants in this group receive individually face-to- face cognitive behavioral therapy, once a week 8 sessions 50 minutes. Anxiety. Timepoint: beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2) and 6 months. Method of measurement: Beck Anxiety questionnaire. Depression. Timepoint: beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2). Method of measurement: Beck depression questionnaire. Patient’s health. Timepoint: beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2). Method of measurement: 9-questions patient's health questionnaire (PHQ-9). Infertility stress. Timepoint: beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2). Method of measurement: Fertility problem inventory. Covid-19 anxiety. Timepoint: beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2) and 6 months. Method of measurement: Covid-19 anxiety questionnaire. Patient treatment satisfaction. Timepoint: beginning of the intervention, 4 weeks after the beginning of the intervention, end of the intervention (month 2) and 6 months. Method of measurement: Patient treatment satisfaction questionnaire. National Institute for Medical Research Development (NIMAD) Approved 2019-06-16 National Institute for Medical Research Development (NIMAD) National Institute for Development of Medical Research (NIMAD), No. 21, Besat St., West Fatemi St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)