Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression
Primary Purpose
Post Partum Depression
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cooperative Education Program based on Precede-Proceed Model
Sponsored by
About this trial
This is an interventional prevention trial for Post Partum Depression
Eligibility Criteria
Inclusion Criteria:
- Informed consent to participate in the research
- Gestational age 30-35 weeks
- Be literate
- No history of depression or mental illness in the past
- Healthy fetus on ultrasound
Exclusion Criteria:
- Having a preterm birth
- Refusal to attend training sessions
Sites / Locations
- Gonabad University of Medical ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cooperative Education Program
Control
Arm Description
We explore the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression.
We provide routine care for these people during pregnancy
Outcomes
Primary Outcome Measures
Postpartum Depression
Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. It includes 10 questions and each question is scored from 0 to 3. The total score ranges from 0 to 30 and a score of 10-13 indicates mild postpartum depression while a score of 14-15 indicates moderate postpartum depression. Score of 16 or higher is considered as severe depression which necessitates introduction to a psychologist.
Secondary Outcome Measures
Predisposing, reinforcing and enabling factors inventory
for this section, a questionnaire was designed based on a literature review and according to educational and ecological Phase of precede-proceed model. Predisposing factors will be measured using 10 and 18 questions regarding knowledge and attitude, respectively. The second section of the questionnaire will be related to the enabling factors which were measured through 6 questions. Yes or no questions were designed and scored as follows: no=1, somewhat=2, yes=3. The third section of the questionnaire measures reinforcing factors through 2 questions with yes, no and somewhat answers being scored as 2, 0 and 1, respectively.
General health questionnaire (GHQ)
The General Health Questionnaire (GHQ) is a screening device for identifying minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients.it consists of 4 subscales including physical symptoms, anxiety symptoms, social functioning and depressive symptoms. Each scale is made of 7 questions which are assessed based on a Likert scale scoring as never (0), few (1), high (2) and very high (3). The total score for each person ranges from 0 to 84. Cutoff point for the questionnaire is reported to be 23. In this method, individuals with score of 23 or less are considered healthy and those with score of 24 or higher are suspected to be mentally disordered.
Full Information
NCT ID
NCT04129476
First Posted
October 9, 2019
Last Updated
October 15, 2019
Sponsor
Gonabad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04129476
Brief Title
Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression
Official Title
Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gonabad University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trail aims to evaluate the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression in southern Razavi Khorasan Province.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cooperative Education Program
Arm Type
Experimental
Arm Description
We explore the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression.
Arm Title
Control
Arm Type
No Intervention
Arm Description
We provide routine care for these people during pregnancy
Intervention Type
Behavioral
Intervention Name(s)
Cooperative Education Program based on Precede-Proceed Model
Intervention Description
The study population is pregnant women in Gonabad city between 30 and 35 weeks of gestation. In the experimental group, the training program was based on the PRECEDE-PROCEDURE model, including training on anatomy and prenatal physiology, prenatal and postnatal care, prenatal and postnatal mental health, as well as prenatal and postnatal events, and Mothers' feelings and attitudes, as well as postpartum problems and strategies will be discussed. The training period is 60 minutes in 4 consecutive sessions. Predisposing, reinforcing and enabling factors inventory, General health questionnaire (GHQ), Edinburgh depression inventory Will be filled Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
Primary Outcome Measure Information:
Title
Postpartum Depression
Description
Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. It includes 10 questions and each question is scored from 0 to 3. The total score ranges from 0 to 30 and a score of 10-13 indicates mild postpartum depression while a score of 14-15 indicates moderate postpartum depression. Score of 16 or higher is considered as severe depression which necessitates introduction to a psychologist.
Time Frame
Edinburgh Postnatal Depression Scale will be filled from baseline to 6 week
Secondary Outcome Measure Information:
Title
Predisposing, reinforcing and enabling factors inventory
Description
for this section, a questionnaire was designed based on a literature review and according to educational and ecological Phase of precede-proceed model. Predisposing factors will be measured using 10 and 18 questions regarding knowledge and attitude, respectively. The second section of the questionnaire will be related to the enabling factors which were measured through 6 questions. Yes or no questions were designed and scored as follows: no=1, somewhat=2, yes=3. The third section of the questionnaire measures reinforcing factors through 2 questions with yes, no and somewhat answers being scored as 2, 0 and 1, respectively.
Time Frame
Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
Title
General health questionnaire (GHQ)
Description
The General Health Questionnaire (GHQ) is a screening device for identifying minor psychiatric disorders in the general population and within community or non-psychiatric clinical settings such as primary care or general medical out-patients.it consists of 4 subscales including physical symptoms, anxiety symptoms, social functioning and depressive symptoms. Each scale is made of 7 questions which are assessed based on a Likert scale scoring as never (0), few (1), high (2) and very high (3). The total score for each person ranges from 0 to 84. Cutoff point for the questionnaire is reported to be 23. In this method, individuals with score of 23 or less are considered healthy and those with score of 24 or higher are suspected to be mentally disordered.
Time Frame
Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Informed consent to participate in the research
Gestational age 30-35 weeks
Be literate
No history of depression or mental illness in the past
Healthy fetus on ultrasound
Exclusion Criteria:
Having a preterm birth
Refusal to attend training sessions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahdi Moshki
Phone
98515723028
Email
drmoshki@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Atefeh Dehnoalian
Phone
989156453622
Email
adehnoalian@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baloochi
Organizational Affiliation
Gonabad University of Medical Science
Official's Role
Study Chair
Facility Information:
Facility Name
Gonabad University of Medical Science
City
Gonabad
State/Province
Khorasan Razavi
ZIP/Postal Code
985157223028
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atefeh Dehnoalian
Phone
989156453622
Email
adehnoalian@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression
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