Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression

Post Partum Depression Clinical Trial

Official title:

Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04129476
• Other study ID #: GonabadUMS
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: October 2019
• Source: Gonabad University of Medical Sciences
• Contact: Mahdi Moshki
• Phone: 98515723028
• Email: drmoshki[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post Partum Depression

Intervention

Behavioral:
• Cooperative Education Program based on Precede-Proceed Model
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Gonabad University of Medical Science	Gonabad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Gonabad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Edinburgh Postnatal Depression Scale will be filled from baseline to 6 week
Secondary	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.	Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
Secondary	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.	Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.