]>
IRCT20110228005931N11 IRCT 2021-12-22 Babol University of Medical Sciences Effect of internet-based emotion-focused therapy on the anxiety of women with a suspected fetal malformation The effect of internet-based emotion-focused therapy on anxiety and pregnancy outcomes in anxious women with a suspected fetal malformation 2021-11-22 anticipated 408 Complete https://irct.ir/trial/59404 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: A randomized controlled clinical trial with four-arm parallel, Randomization description: After checking inclusion and exclusion criteria, participants are allocated randomly into four groups by permuted block randomization method. The block size is 4 and by using the statistical software, Each block of each intervention group will be repeated once, As a result, we will have 35 different blocks, Then, using the statistical program in R software environment version 11, 35 blocks of 4 will be generated, which will produce a total of 140 sequences. Randomization is assigned by standalone statistical software using a computer random sequence to assign participants to one of four study groups using this randomly generated list. N/A Anxiety disorder. Intervention 1: In this group, the participants will receive Internet emotion-focused therapy for six 90-minute sessions once a week. During the sessions, participants will interact with the content of the program via videos, text, audio, audio clips, therapist explanations, and relevant practices. During the therapy, patients will acquire necessary skills, including identifying and evaluating thoughts, recognizing emotions, and emotion management skills. Patients' assignments will be online both during the sessions and the week and will be sent to the therapist. The therapist will also reflect feedback on assignments to patients via SMS. Intervention 2: The participants of the group will be received IEFT( 6 sessions of online treatment with duration 90 minutes, once a week) with 6sessions of mreminder dose (after treatment, one session every month for 6 months). Intervention 3: The participants of the group will be received IEFT( 6 sessions of online treatment with duration 90 minutes, once a week) with the participation of their husband during treatment. Intervention 4: The participants of the group will be received IEFT( 6 sessions of an online treatment with duration 90 minutes, once a week) with the participation of their husband during treatment, as well as reminder dose (after treatment, once session every month for 6 months ). 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 Undecided - It is not yet known if there will be a plan to make this available
public Dr. Mahbobeh Faramarzi
Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 47745-47176 +98 11 1219 9592 Mahbob330@yahoo.com Babol University of Medical Sciences scientific Dr.Mahbobeh Faramarzi
Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 47745-47176 +98 11 1219 9592 Mahbob330@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Gestational age of less than 20 weeks Suspected of fetal malformation based on diagnosis by a gynecologist Spielberger's anxiety score above 30 Educational level higher than primary school Consent of the woman and her husband to enter treatment َAccess to computers and the Internet 18 years no limit Both Current substance abuse Current use of sedative drugs like benzodiazepines, or recent psychotherapy for depression/anxiety (<4 weeks) Severe psychiatric disorders such as severe anxiety, sever depression, and suicidal thought F41.9 Anxiety disorder, unspecified Treatment - Other Treatment - Other Treatment - Other Treatment - Other In this group, the participants will receive Internet emotion-focused therapy for six 90-minute sessions once a week. During the sessions, participants will interact with the content of the program via videos, text, audio, audio clips, therapist explanations, and relevant practices. During the therapy, patients will acquire necessary skills, including identifying and evaluating thoughts, recognizing emotions, and emotion management skills. Patients' assignments will be online both during the sessions and the week and will be sent to the therapist. The therapist will also reflect feedback on assignments to patients via SMS. The participants of the group will be received IEFT( 6 sessions of online treatment with duration 90 minutes, once a week) with 6sessions of mreminder dose (after treatment, one session every month for 6 months) The participants of the group will be received IEFT( 6 sessions of online treatment with duration 90 minutes, once a week) with the participation of their husband during treatment. The participants of the group will be received IEFT( 6 sessions of an online treatment with duration 90 minutes, once a week) with the participation of their husband during treatment, as well as reminder dose (after treatment, once session every month for 6 months ) ََAnxiety. Timepoint: Before intervention, at the end of intervention (6 weeks post-trial ), follow-up of 3 and 6 months after the intervention. Method of measurement: Spielberger's anxiety questionnaire. ٍEmotion regulation. Timepoint: Before intervention, at the end of intervention (6 weeks post-trial ), follow-up of 3 and 6 months after the intervention. Method of measurement: Cognitive emotion regulation questionnaire. Uncertainty intolerance. Timepoint: Before intervention, at the end of intervention (6 weeks post-trial ), follow-up of 3 and 6 months after the intervention. Method of measurement: Uncertainty Intolerance Questionnaire. Pregnancy stress. Timepoint: Before intervention, at the end of intervention (6 weeks post-trial ), follow-up of 3 and 6 months after the intervention. Method of measurement: Revised Pregnancy Distress Questionnaire (NuPDQ). Depression. Timepoint: Before intervention, at the end of intervention (6 weeks post-trial ), follow-up of 3 and 6 months after the intervention. Method of measurement: Edinburgh Postnatal depression questionnaire. Babol University of Medical Sciences Approved 2021-04-30 Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran, Babol Babol Mazandaran Iran (Islamic Republic of)