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IRCT20110228005931N10 IRCT 2021-09-10 Islamic Azad University Effect of internet-based emotion-focused cognitive behavior therapy with spouse participation on stress of anxious pregnant women The effectiveness of internet-based emotion-focused cognitive behavior therapy (iECBT) with and without spouse participation on psychological distress and stress in pregnant women with anxiety disorders 2021-09-23 anticipated 82 Complete https://irct.ir/trial/57842 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: ٍEligible participants will allocate randomly two groups (42 individuals) by permuted block randomization method. The block size is 4 and the allocation ratio is 1:1. In each block, intervention groups will be repeated twice. Therfore, we will have 21 different blocks. Then, using the statistical program in R software version 3.6.1, 4 part blocks will be generated 21 times, which will produce a total of 84 sequences. N/A Anxiety disorder. Intervention 1: Intervention group: The participants in this group receive iECBT with spouse participation once a week, 8 session 1 hour. Intervention 2: Intervention group: The participants in this group receive iECBT without spouse participation once a week, 8 session 1 hour. 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 Azadeh Farghadani
BLV. Shahid Fahmideh, BLV. Shahid Beheshti, Saveh, Markazi province, Iran.
ُSaveh Iran (Islamic Republic of) 366 - 39187 +98 86 4243 3342 Farghadani@iau_saveh.ac.ir Islamic Azad University scientific Mahbobeh Faramarzi
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 47745-47176 +98 11 3222 3594 Mahbob330@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Gestational age of 13-28 weeks Diagnosis of anxiety disorder based on SCID-5 Access to computers and the Internet Education level of higher than primary school consent of the wife and her husband to enter the study 18 years no limit Both Current substance abuse or dependence Currently use of sedatives Receive psychotherapy during past months ago Abortion, preterm labor, termination of pregnancy women with severe anxiety disorders who required medical treatment ُSevere psychiatric disorders and suicidal ideation F41.9 Anxiety disorderS Treatment - Other Treatment - Other Intervention group: The participants in this group receive iECBT with spouse participation once a week, 8 session 1 hour. Intervention group: The participants in this group receive iECBT without spouse participation once a week, 8 session 1 hour. Anxiety. Timepoint: Before the intervention, at end of the intervention, and follow- ups of 1 and 3 months after the end of intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI). Psychological distress. Timepoint: Before the intervention, at end of the intervention, and follow- ups of 1 and 3 months after the end of intervention. Method of measurement: Brief Syndrome Inventory (BSI-18). Pregnancy stress. Timepoint: Before the intervention, at end of the intervention, and follow- ups of 1 and 3 months after the end of intervention. Method of measurement: Revised Prenatal Distress Questionnaire (NuPDQ). Emotion regulation. Timepoint: Before the intervention, at end of the intervention, and follow- ups of 1 and 3 months after the end of intervention. Method of measurement: Cognitive emotion regulation questionnaire (CERQ). Islamic Azad University Approved 2021-07-03 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Babol, Iran. Babol Mazandaran Iran (Islamic Republic of)