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Protocol summary
The method is a randomized controlled clinical trial with a four-arm parallel type. 408 patients will be included in the study through randomization using R software.
The method is a randomized controlled clinical trial with a four-arm parallel type. 140 patients will be included in the study through randomization using R software.
The method is a randomized controlled clinical trial with a four-arm parallel type. 408140 patients will be included in the study through randomization using R software.
روش کار، کارازمایی بالینی کنترل شده تصادفی از نوع چهار بازوی موازی است. 408 بیماراز طریق تصادفی سازی با استفاده از نرم افزار R وارد مطالعه خواهند شد.
روش کار، کارازمایی بالینی کنترل شده تصادفی از نوع چهار بازوی موازی است. 140 بیماراز طریق تصادفی سازی با استفاده از نرم افزار R وارد مطالعه خواهند شد.
روش کار، کارازمایی بالینی کنترل شده تصادفی از نوع چهار بازوی موازی است. 408140 بیماراز طریق تصادفی سازی با استفاده از نرم افزار R وارد مطالعه خواهند شد.
408 anxious pregnant women with suspected fetal malformation will be selected from public hospitals and private offices in Babol City. Participants will be divided into four groups in a four-arm parallel randomized clinical trial, including IEFT alone, IEFT combined with a booster dose, IEFT along with spouse participation, IEFT along with spouse participation, and a booster dose. The content of the four types of therapy will be prepared online. The content validity in the therapies will be confirmed by a specialized team. All participants will complete five questionnaires, namely Spielberger's state anxiety, pregnancy-specific stress, uncertainty intolerance questionnaire, emotion regulation, and Edinburgh postnatal depression, before the trial, at the end of the 6-week intervention, 3-month and 6-month post-trial follow-ups.
140 anxious pregnant women with suspected fetal malformation will be selected from public hospitals and private offices in Babol City. Participants will be divided into four groups in a four-arm parallel randomized clinical trial, including IEFT alone, IEFT combined with a booster dose, IEFT along with spouse participation, IEFT along with spouse participation, and a booster dose. The content of the four types of therapy will be prepared online. The content validity in the therapies will be confirmed by a specialized team. All participants will complete five questionnaires, namely Spielberger's state anxiety, pregnancy-specific stress, uncertainty intolerance questionnaire, emotion regulation, and Edinburgh postnatal depression, before the trial, at the end of the 6-week intervention, 3-month and 6-month post-trial follow-ups.
408140 anxious pregnant women with suspected fetal malformation will be selected from public hospitals and private offices in Babol City. Participants will be divided into four groups in a four-arm parallel randomized clinical trial, including IEFT alone, IEFT combined with a booster dose, IEFT along with spouse participation, IEFT along with spouse participation, and a booster dose. The content of the four types of therapy will be prepared online. The content validity in the therapies will be confirmed by a specialized team. All participants will complete five questionnaires, namely Spielberger's state anxiety, pregnancy-specific stress, uncertainty intolerance questionnaire, emotion regulation, and Edinburgh postnatal depression, before the trial, at the end of the 6-week intervention, 3-month and 6-month post-trial follow-ups.
408 باردار مضطرب مشکوک به داشتن جنین ناهنجار ، از بیمارستان های دولتی، و مطب های خصوصی شهر بابل انتخاب خواهند شد. شرکت کنندگان در یک کارآزمایی بالینی تصادفی موازی از نوع چهار بازو در چهارگروه تقسیم می شوند، شامل: درمان IEFT به تنهایی، درمان IEFT توام با دوز یادآور، درمان IEFT توام با مشارکت همسر، درمان IEFT توام یا مشارکت همسر و دوز یادآور. محتوای چهارنوع درمان بصورت اینترنی آماده خواهد شد. روایی محتوای در درمانها از طریق تیم تخصصی تایید خواهد شد. همه شرکت کنندگان پنج پرسشنامه اضطراب حالت اشپیلبرگر،استرس اختصاصی بارداری، عدم تحمل بلاتکلیفی، تنظیم هیجان، و افسردگی ادینبرگ را پیش از شروع کارآزمایی، در پایان 6 هفته مداخله، و پیگیری های 3 ماه و 6 ماهه بعد از مداخلات تکمیل خواهند کرد
140 باردار مضطرب مشکوک به داشتن جنین ناهنجار ، از بیمارستان های دولتی، و مطب های خصوصی شهر بابل انتخاب خواهند شد. شرکت کنندگان در یک کارآزمایی بالینی تصادفی موازی از نوع چهار بازو در چهارگروه تقسیم می شوند، شامل: درمان IEFT به تنهایی، درمان IEFT توام با دوز یادآور، درمان IEFT توام با مشارکت همسر، درمان IEFT توام یا مشارکت همسر و دوز یادآور. محتوای چهارنوع درمان بصورت اینترنی آماده خواهد شد. روایی محتوای در درمانها از طریق تیم تخصصی تایید خواهد شد. همه شرکت کنندگان پنج پرسشنامه اضطراب حالت اشپیلبرگر،استرس اختصاصی بارداری، عدم تحمل بلاتکلیفی، تنظیم هیجان، و افسردگی ادینبرگ را پیش از شروع کارآزمایی، در پایان 6 هفته مداخله، و پیگیری های 3 ماه و 6 ماهه بعد از مداخلات تکمیل خواهند کرد
408140 باردار مضطرب مشکوک به داشتن جنین ناهنجار ، از بیمارستان های دولتی، و مطب های خصوصی شهر بابل انتخاب خواهند شد. شرکت کنندگان در یک کارآزمایی بالینی تصادفی موازی از نوع چهار بازو در چهارگروه تقسیم می شوند، شامل: درمان IEFT به تنهایی، درمان IEFT توام با دوز یادآور، درمان IEFT توام با مشارکت همسر، درمان IEFT توام یا مشارکت همسر و دوز یادآور. محتوای چهارنوع درمان بصورت اینترنی آماده خواهد شد. روایی محتوای در درمانها از طریق تیم تخصصی تایید خواهد شد. همه شرکت کنندگان پنج پرسشنامه اضطراب حالت اشپیلبرگر،استرس اختصاصی بارداری، عدم تحمل بلاتکلیفی، تنظیم هیجان، و افسردگی ادینبرگ را پیش از شروع کارآزمایی، در پایان 6 هفته مداخله، و پیگیری های 3 ماه و 6 ماهه بعد از مداخلات تکمیل خواهند کرد
General information
2023-02-20, 1401/12/01
2023-06-30, 1402/04/09
2023-0206-2030 00:00:00
empty
In the description of randomization, the sample size was reduced to 140 people.
The end time of the study was changed to June 30.
In the description of randomization, the sample size was reduced to 140 people. The end time of the study was changed to June 30.
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در بخش توصیف تصادفی سازی، حجم نمونه به 140 نفر کاهش یافت.
زمان پایان مطالعه به 30 جون تغییر یافت.
در بخش توصیف تصادفی سازی، حجم نمونه به 140 نفر کاهش یافت. زمان پایان مطالعه به 30 جون تغییر یافت.
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 102 different blocks, Then, using the statistical program in R software environment version 11, 102 blocks of 4 will be generated, which will produce a total of 408 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.
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.
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 10235 different blocks, Then, using the statistical program in R software environment version 11, 10235 blocks of 4 will be generated, which will produce a total of 408140 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.
نحوه تخصیص آزمودنی ها پس از اعمال معیارهای ورود و خروج به صورت تخصیص تصادفی به روش بلوکی جایگشتی خواهد بود. سایز بلوک ها4 تایی می باشد و در هر بلوک هر گروه مداخله یکبار تکرار خواهد شد. در نتیجه 102بلوک متفاوت خواهیم داشت. سپس با استفاده از برنامه آماری در محیط نرم افزار R نسخه 11 ، تعداد102 بار بلوک 4تایی تولید خواهد شد که در مجموع یک توالی به سایز408 تولید خواهد شد. واحد تصادفی سازی، توسط یک نرم افزار آماری مستقل با استفاده از یک توالی تصادفی رایانه ای اختصاص داده شده است تا با استفاده از این لیست که بطور تصادفی تولید شده، شرکت کنندگان به یکی از چهارگروه مورد مطالعه تخصیص داده می شوند.
نحوه تخصیص آزمودنی ها پس از اعمال معیارهای ورود و خروج به صورت تخصیص تصادفی به روش بلوکی جایگشتی خواهد بود. سایز بلوک ها4 تایی می باشد و در هر بلوک هر گروه مداخله یکبار تکرار خواهد شد. در نتیجه 35بلوک متفاوت خواهیم داشت. سپس با استفاده از برنامه آماری در محیط نرم افزار R نسخه 11 ، تعداد35 بار بلوک 4تایی تولید خواهد شد که در مجموع یک توالی به سایز140 تولید خواهد شد. واحد تصادفی سازی، توسط یک نرم افزار آماری مستقل با استفاده از یک توالی تصادفی رایانه ای اختصاص داده شده است تا با استفاده از این لیست که بطور تصادفی تولید شده، شرکت کنندگان به یکی از چهارگروه مورد مطالعه تخصیص داده می شوند.
نحوه تخصیص آزمودنی ها پس از اعمال معیارهای ورود و خروج به صورت تخصیص تصادفی به روش بلوکی جایگشتی خواهد بود. سایز بلوک ها4 تایی می باشد و در هر بلوک هر گروه مداخله یکبار تکرار خواهد شد. در نتیجه 102بلوک35بلوک متفاوت خواهیم داشت. سپس با استفاده از برنامه آماری در محیط نرم افزار R نسخه 11 ، تعداد102تعداد35 بار بلوک 4تایی تولید خواهد شد که در مجموع یک توالی به سایز408سایز140 تولید خواهد شد. واحد تصادفی سازی، توسط یک نرم افزار آماری مستقل با استفاده از یک توالی تصادفی رایانه ای اختصاص داده شده است تا با استفاده از این لیست که بطور تصادفی تولید شده، شرکت کنندگان به یکی از چهارگروه مورد مطالعه تخصیص داده می شوند.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mahbobeh Faramarzi
Full name of responsible person - Persian: دکتر محبوبه فرامرزی
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
Street address - Persian: ایران،مازندران،بابل،خیابان گنج افروز،دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 47745-47176
Phone: +98 11 1219 9592
Mobile: +98 911 112 2259
Fax: +98 11 1219 9592
Email: Mahbob330@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mahbobeh Faramarzi
Full name of responsible person - Persian: دکتر محبوبه فرامرزی
Position - English: Professor
Position - Persian: استاد
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
Street address - Persian: ایران،مازندران،بابل،خیابان گنج افروز،دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 47745-47176
Phone: +98 11 1219 9592
Mobile: +98 911 112 2259
Fax: +98 11 1219 9592
Email: Mahbob330@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Mahbobeh Faramarzi Full name of responsible person - Persian: دکتر محبوبه فرامرزی Position - English: Associate professorProfessor Position - Persian: دانشیاراستاد Latest degree: phd Area of specialty/work: 48 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran Street address - Persian: ایران،مازندران،بابل،خیابان گنج افروز،دانشگاه علوم پزشکی بابل City - English: Babol City - Persian: بابل Province: Mazandaran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 47745-47176 Phone: +98 11 1219 9592 Mobile: +98 911 112 2259 Fax: +98 11 1219 9592 Email: Mahbob330@yahoo.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Mahbobeh Faramarzi
Full name of responsible person - Persian: دکتر محبوبه فرامرزی
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
Street address - Persian: ایران،مازندران،بابل،خیابان گنج افروز،دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 47745-47176
Phone: +98 11 1219 9592
Mobile: +98 911 112 2259
Fax: +98 11 1219 9592
Email: Mahbob330@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Mahbobeh Faramarzi
Full name of responsible person - Persian: دکتر محبوبه فرامرزی
Position - English: Professor
Position - Persian: استاد
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
Street address - Persian: ایران،مازندران،بابل،خیابان گنج افروز،دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 47745-47176
Phone: +98 11 1219 9592
Mobile: +98 911 112 2259
Fax: +98 11 1219 9592
Email: Mahbob330@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.Mahbobeh Faramarzi Full name of responsible person - Persian: دکتر محبوبه فرامرزی Position - English: Associate professorProfessor Position - Persian: دانشیاراستاد Latest degree: phd Area of specialty/work: 48 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran Street address - Persian: ایران،مازندران،بابل،خیابان گنج افروز،دانشگاه علوم پزشکی بابل City - English: Babol City - Persian: بابل Province: Mazandaran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 47745-47176 Phone: +98 11 1219 9592 Mobile: +98 911 112 2259 Fax: +98 11 1219 9592 Email: Mahbob330@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Mahbobeh Faramarzi
Full name of responsible person - Persian: دکتر محبوبه فرامرزی
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
Street address - Persian: ایران،مازندران،بابل،خیابان گنج افروز،دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 47745-47176
Phone: +98 911 112 2259
Mobile: +98 11 1219 9592
Fax: +98 11 1219 9592
Email: Mahbob330@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Mahbobeh Faramarzi
Full name of responsible person - Persian: دکتر محبوبه فرامرزی
Position - English: Professor
Position - Persian: استاد
Latest degree: phd
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
Street address - Persian: ایران،مازندران،بابل،خیابان گنج افروز،دانشگاه علوم پزشکی بابل
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 47745-47176
Phone: +98 911 112 2259
Mobile: +98 11 1219 9592
Fax: +98 11 1219 9592
Email: Mahbob330@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.Mahbobeh Faramarzi Full name of responsible person - Persian: دکتر محبوبه فرامرزی Position - English: Associate professorProfessor Position - Persian: دانشیاراستاد Latest degree: phd Area of specialty/work: 48 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran Street address - Persian: ایران،مازندران،بابل،خیابان گنج افروز،دانشگاه علوم پزشکی بابل City - English: Babol City - Persian: بابل Province: Mazandaran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 47745-47176 Phone: +98 911 112 2259 Mobile: +98 11 1219 9592 Fax: +98 11 1219 9592 Email: Mahbob330@yahoo.com Web page address:
Protocol summary
Study aim
Reduction of anxiety and improvement of pregnancy outcome in women suspected with fetal malformation
Design
The method is a randomized controlled clinical trial with a four-arm parallel type. 140 patients will be included in the study through randomization using R software.
Settings and conduct
140 anxious pregnant women with suspected fetal malformation will be selected from public hospitals and private offices in Babol City. Participants will be divided into four groups in a four-arm parallel randomized clinical trial, including IEFT alone, IEFT combined with a booster dose, IEFT along with spouse participation, IEFT along with spouse participation, and a booster dose. The content of the four types of therapy will be prepared online. The content validity in the therapies will be confirmed by a specialized team. All participants will complete five questionnaires, namely Spielberger's state anxiety, pregnancy-specific stress, uncertainty intolerance questionnaire, emotion regulation, and Edinburgh postnatal depression, before the trial, at the end of the 6-week intervention, 3-month and 6-month post-trial follow-ups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age under 20 weeks, suspected fetal malformation, anxiety score above 30, education level higher than primary school, access to the Internet.
Exclusion criteria: Substance abuse, the current use of tranquilizers, severe psychiatric disorders such as severe anxiety, major depression, schizophrenia, bipolar disorder, and suicidal ideation.
Intervention groups
Intervention group 1: only internet-based emotion-focused therapy (IEFT)
Intervention group 2: IEFT with reminder dose
Intervention group 3: IEFT with spouse participation
Intervention group 4: IEFT with both spouse participation and dose reminder
Main outcome variables
Anxiety symptoms, Emotion regulation
General information
Reason for update
In the description of randomization, the sample size was reduced to 140 people.
The end time of the study was changed to June 30.
Acronym
IRCT registration information
IRCT registration number:IRCT20110228005931N11
Registration date:2021-12-22, 1400/10/01
Registration timing:registered_while_recruiting
Last update:2023-04-24, 1402/02/04
Update count:1
Registration date
2021-12-22, 1400/10/01
Registrant information
Name
Mahbobeh Faramarzi
Name of organization / entity
Babol University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 4456
Email address
m.faramarzi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of internet-based emotion-focused therapy on anxiety and pregnancy outcomes in anxious women with a suspected fetal malformation
Public title
Effect of internet-based emotion-focused therapy on the anxiety of women with a suspected fetal malformation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
408
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
A randomized controlled clinical trial with four-arm parallel
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran, Babol
City
Babol
Province
Mazandaran
Postal code
47745-47176
Approval date
2021-04-30, 1400/02/10
Ethics committee reference number
IR.MUBABOL.REC.1400.072
Health conditions studied
1
Description of health condition studied
Anxiety disorder
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
ََ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
2
Description
ٍ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
Secondary outcomes
1
Description
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
2
Description
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)
3
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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)
Category
Treatment - Other
3
Description
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.
Category
Treatment - Other
4
Description
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 )
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani Hospital
Full name of responsible person
Shahnaz Barat
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 83 0032 2311
Email
a.ghanbar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Mahbobeh Faramarzi
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 1219 9592
Fax
+98 11 1219 9592
Email
Mahbob330@yahoo.com
Grant name
Master of Thesis
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mahbobeh Faramarzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 1219 9592
Fax
+98 11 1219 9592
Email
Mahbob330@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Mahbobeh Faramarzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 1219 9592
Fax
+98 11 1219 9592
Email
Mahbob330@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr.Mahbobeh Faramarzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, GanjafrozAvenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 911 112 2259
Fax
+98 11 1219 9592
Email
Mahbob330@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available