ClinicalTrials.gg
Status unknownNCT04129476Updated Oct 16, 2019

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

An interventional study of Cooperative Education Program based on Precede-Proceed Model in Post Partum Depression, sponsored by Gonabad University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-16.

Sponsored by Gonabad University of Medical Sciences · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Sex
Female
01

Study 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.

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Conditions studied

  • Post Partum Depression
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In context

Depression, Postpartum

569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.

This study's planned enrollment of 140 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Gonabad University of Medical Sciences is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion Criteria:

  • Having a preterm birth
  • Refusal to attend training sessions
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (estimated)

Study arms

  • 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

  • No intervention
    Control

    We provide routine care for these people during pregnancy

Interventions

  • BehavioralCooperative 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Edinburgh Postnatal Depression Scale will be filled from baseline to 6 week

Secondary outcomes

  1. 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.

    Time frame: Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.

  2. 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.

    Time frame: Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.

07

Study locations

1 of 1 sites recruiting
  • Gonabad University of Medical Science
    Gonabad, Khorasan Razavi 985157223028, Iran, Islamic Republic of
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04129476
Lead sponsor
Gonabad University of Medical Sciences
Responsible party
Atefeh Dehnoalian (Principal Investigator, Gonabad University of Medical Sciences) — Principal investigator
First posted
Oct 16, 2019
Start date
Nov 1, 2019 (estimated)
Primary completion
Nov 1, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Oct 16, 2019

Study contacts

Mahdi Moshki
Contact
drmoshki@gmail.com
98515723028
Atefeh Dehnoalian
Contact
adehnoalian@gmail.com
989156453622
Baloochi
study chair · Gonabad University of Medical Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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