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

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.

Study Overview

• Status: Unknown
• Conditions: Post Partum Depression
• Intervention / Treatment: Behavioral: Cooperative Education Program based on Precede-Proceed Model

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Khorasan Razavi
    • Gonabad, Khorasan Razavi, Iran, Islamic Republic of, 985157223028
      • Recruiting
      • Gonabad University of Medical Science
      • Contact: Atefeh Dehnoalian; Phone Number: 989156453622; Email: adehnoalian@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cooperative Education Program; We explore the effects of a cooperative education program based on precede-proceed model during pregnancy on preventing postpartum depression.	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.
No Intervention: Control; We provide routine care for these people during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Gonabad University of Medical Sciences
• Investigators: Study Chair: Baloochi, Gonabad University of Medical Science

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: GonabadUMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No