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

Sponsor
Gonabad University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT04129476
Collaborator
(none)
140
1
2
30
142

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cooperative Education Program based on Precede-Proceed Model
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression
Anticipated Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Postpartum Depression [Edinburgh Postnatal Depression Scale will be filled from baseline to 6 week]

    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

  1. Predisposing, reinforcing and enabling factors inventory [Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.]

    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.

  2. General health questionnaire (GHQ) [Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gonabad University of Medical Science Gonabad Khorasan Razavi Iran, Islamic Republic of 985157223028

Sponsors and Collaborators

  • Gonabad University of Medical Sciences

Investigators

  • Study Chair: Baloochi, Gonabad University of Medical Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Atefeh Dehnoalian, Principal Investigator, Gonabad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT04129476
Other Study ID Numbers:
  • GonabadUMS
First Posted:
Oct 16, 2019
Last Update Posted:
Oct 16, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2019