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
Intervention group2: The participants in this group receive iECBT without spouse participation once a week, 8 session 1 hour.
Settings and conduct
This study will be conducted on pregnant women who referring to the affiliated hospitals of Babol University of Medical Sciences and private offices of obstetricians and gynecologists. Pregnant women with anxiety disorders allocate randomly into two experimental groups.The participants of group A (42 persons) will receive iECBT with spouse participation. The participants of group B (42 persons) will be received iECBT without spouse participation iCBT sessions are performed for 8 weeks (1 hour session per week), which is done with the participation of the spouse and without the participation of the spouse.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age 13-28 weeks, diagnosis of anxiety disorders based on SCID-5, access to computers and the Internet, education level of higher than primary school, consent of the woman and her husband to enter the study. Exclusion criteria: current substance abuse or dependence, currently using of sedatives, Receiving psychotherapy during past six months, women who have an abortion, premature birth, terminated pregnancy during the intervention, women diagnosed with severe anxiety disorders,, severe psychiatric disorders and suicidal ideation.
Intervention groups
Intervention group1: The participants in this group receive iECBT with spouse participation once a week, 8 session 1 hour.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110228005931N10
Registration date:2021-09-10, 1400/06/19
Registration timing:prospective
Last update:2021-09-10, 1400/06/19
Update count:0
Registration date
2021-09-10, 1400/06/19
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
2021-09-23, 1400/07/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of internet-based emotion-focused cognitive behavior therapy with spouse participation on stress of anxious pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Babol, Iran.
City
Babol
Province
Mazandaran
Postal code
47745-47176
Approval date
2021-07-03, 1400/04/12
Ethics committee reference number
IR.MUBABOL.RC.1400.164
Health conditions studied
1
Description of health condition studied
Anxiety disorder
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorderS
Primary outcomes
1
Description
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)
2
Description
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)
Secondary outcomes
1
Description
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)
2
Description
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)
Intervention groups
1
Description
Intervention group: The participants in this group receive iECBT with spouse participation once a week, 8 session 1 hour.
Category
Treatment - Other
2
Description
Intervention group: The participants in this group receive iECBT without spouse participation once a week, 8 session 1 hour.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani 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 11 3223 8300
Email
a.ghanbar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mojgan Shariat Panahi
Street address
BLV. Shahid Fahmideh, BLV. Shahid Beheshti, Saveh, Markazi province, Iran.
City
Saveh
Province
Markazi
Postal code
366 - 39187
Phone
+98 86 4243 3342
Email
Mojgelita_50@yahoo.com
Grant name
Thesis in PhD degree
Grant code / Reference number
162397152
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Azadeh Farghadani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
BLV. Shahid Fahmideh, BLV. Shahid Beheshti, Saveh, Markazi province, Iran.
City
ُSaveh
Province
Markazi
Postal code
366 - 39187
Phone
+98 86 4243 3342
Email
Farghadani@iau_saveh.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3222 3594
Email
Mahbob330@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3222 3594
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