The purpose of this study was to investigate the effect of cognitive-behavioral group therapy on pregnancy-related depression. 68 eligible pregnant women with mild or moderate depression (based on Edinburgh's postpartum depression questionnaire) were selected through convenience sampling and were randomly assigned to two groups of 34 (control and test groups) The routine midwifery control group and the intervention group receive 7 sessions of one-hour cognitive-behavioral group therapy twice a week. Immediately after 4 and 8 weeks after the consultation sessions, all samples are invited to complete the questionnaire.
Design
This study is a randomized controlled trial. Samples were randomly divided into two groups of 34 controls and intervention.
Settings and conduct
This is a randomized controlled study that after receiving a written Letter of reference from Ahvaz University of Medical Sciences, received the Ethics Code from the Jundishapur University of Medical Sciences Ahwaz Medical Center, Shoushtar city due to the large number of pregnant women Covered by these centers will be referred.
Participants/Inclusion and exclusion criteria
Inclusion criteria: First gravid; Age of 15 to 45 years; Ability to speak Persian; Literacy of reading and writing; Earn Score 10 to 15 from the Edinburgh Postpartum Depression Scale; gestational age between 22 to 26 weeks.
Exclusion criteria: Drug abuse; Mental illnesses other than depression; Neurological diseases; Receive any treatment during research for depression; Body Mass Index more than 25
Intervention groups
The control group will receive the routine obstetric cares from a midwife of the health center. The intervention includes: cognitive-behavioral therapy and its role in depression, self-care, learning to solve problems, and challenging negative thoughts.
Main outcome variables
Reduce depression during pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180823040855N1
Registration date:2018-09-12, 1397/06/21
Registration timing:registered_while_recruiting
Last update:2018-09-12, 1397/06/21
Update count:0
Registration date
2018-09-12, 1397/06/21
Registrant information
Name
masumeh mehri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3623 3430
Email address
mehri.m@stu.ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-18, 1397/04/27
Expected recruitment end date
2018-09-18, 1397/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Self-Care-Based Cognitive Behavioral Therapy on Depression During Pregnancy
Public title
The Effectiveness of Self-Care-Based Cognitive Behavioral Therapy on Depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gravid First
Age of 15 to 45 years
Ability to speak Persian
Literacy reading and writing
Earn score 10 to 15 from the Edinburgh Postpartum Depression Inventory
Gestational age 22 to 26 weeks
Exclusion criteria:
Drug abuse
Cause of other Mental Illnesses other than Major Depressive Disorder
Neurological Diseases
Receive any Treatment during Research for Major Depressive Disorder
BMI More than 25
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly divided into two groups of intervention and control. The software is random statistical software
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
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan, Esfand Street
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-07-14, 1397/04/23
Ethics committee reference number
IR.AJUMS.REC.۱۳۹۷.۳۱۳
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
Pregnancy Depression Score in Edinburgh Postpartum Depression Questionnaire
Timepoint
At the beginning of the study, immediately, 4 weeks and 8 weeks after the end of the intervention
Method of measurement
Edinburgh Postpartum Depression Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention according to a protocol called cognitive-behavioral self-care cognitive-behavioral therapy, a guide for women, written by Dr. Michel Herring Cognitive-behavioral counseling counselor in collaboration with the British Columbia mental health program, mental health services in British Columbia. The intervention was presented as 7 sessions of one-hour cognitive-behavioral group therapy once a week. The sessions include: providing information on depression, providing information on treatment options in women with depression during pregnancy and postpartum, including drug therapy and psychological treatments such as cognitive-behavioral therapy, explaining cognitive-behavioral therapy and its role in depression, Explain self-care and its importance, a description of different areas of self-care such as nutrition, exercise and the way to incorporate and nurture each of these areas in the person's life, how to determine the goal of developing each of the areas of self-care and learning to solve existing problems To make positive changes in life, educate all kinds of wrong thoughts Intensify depression, learn how to identify and challenge these ideas, and provide solutions to prevent the return of symptoms of depression.
Category
Treatment - Other
2
Description
Control group: The routine midwifery care group will receive a midwife from the health center and will be monitored for interventional factors.