The effect of distance self-compassion education on depression in pregnant women
Design
This randomized clinical trial is a non-blinded study with a control group and parallel design. This randomized, phase 2-3 study will be performed on 72 pregnant women with a diagnosis of depression. Simple randomization is used for randomization and participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at Motazedi comprehensive urban health service center, is not blinded. At the beginning of the study, the Edinburgh Depression Inventory will be provided for the participants and if they get a score of 7-19 and other inclusion criteria, they will be included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age 14-26weeks; 3 depressive symptoms based on DSM5; Single pregnancy
Exclusion criteria: History of mental disorders; History of infertility; History of experiencing accidents over the past year
Intervention groups
In addition to routine pregnancy care, the intervention group will receive 8 sessions (one session per week for 45 minutes ) of compassion-based training virtually through WhatsApp. In this research, the first session will be done individually (to get acquainted with the audience and get their psychological history) and other sessions in groups of 3 people will be done through WhatsApp virtual network video call. The control group will receive routine prenatal care.
Main outcome variables
Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N174
Registration date:2021-09-11, 1400/06/20
Registration timing:prospective
Last update:2021-09-11, 1400/06/20
Update count:0
Registration date
2021-09-11, 1400/06/20
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of distance self-compassion education on depression in pregnant women
Public title
The effect of self-compassion education on depression in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women 20-35 years old
Gestational age 14-26weeks
3 depressive symptoms based on DSM5
Single pregnancy
Exclusion criteria:
History of mental disorders
History of infertility
History of experiencing accidents over the past year
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method. 72 cards are selected and numbers from 1-72 are inserted on the cards. The cards are placed in an envelope. Two of the design partners take one card out of the envelope each time and announce the card number. Paired numbers are assigned to the intervention group and odd numbers to the control group.
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-04-26, 1400/02/06
Ethics committee reference number
IR.KUMS.REC.1400.096
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention, end of the intervention, one month after the intervention
Method of measurement
Using the Edinburgh Depression Inventory (EPDS):
Secondary outcomes
empty
Intervention groups
1
Description
In addition to routine pregnancy care, the intervention group will receive 8 sessions (one session per week for 45 minutes ) of compassion-based training virtually through WhatsApp. In this research, the first session will be done individually (to get acquainted with the audience and get their psychological history) and other sessions in groups of 3 people will be done through WhatsApp virtual network video call.
Category
Behavior
2
Description
The control group will receive routine prenatal care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazedi Comprehensive Urban Health Service Center
Full name of responsible person
Bita Ashabi
Street address
Hafezieh Street, 45 meters second
City
Kermanshah
Province
Kermanshah
Postal code
671581340
Phone
+98 83 3838 4632
Email
bita.ashabi98@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Bita Ashabi
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
bita.ashabi98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mastaneh Kamravamanesh
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
kamravamanesh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Bita Ashabi
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
bita.ashabi98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD