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

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ClinicalTrials.gov Identifier: NCT04129476
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Atefeh Dehnoalian, Gonabad University of Medical Sciences

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
Post Partum Depression Behavioral: Cooperative Education Program based on Precede-Proceed Model Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Postpartum Depression [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129476


Contacts
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Contact: Mahdi Moshki 98515723028 drmoshki@gmail.com
Contact: Atefeh Dehnoalian 989156453622 adehnoalian@gmail.com

Locations
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Iran, Islamic Republic of
Gonabad University of Medical Science Recruiting
Gonabad, Khorasan Razavi, Iran, Islamic Republic of, 985157223028
Contact: Atefeh Dehnoalian    989156453622    adehnoalian@gmail.com   
Sponsors and Collaborators
Gonabad University of Medical Sciences
Investigators
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Study Chair: Baloochi Gonabad University of Medical Science

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Responsible Party: Atefeh Dehnoalian, Principal Investigator, Gonabad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04129476    
Other Study ID Numbers: GonabadUMS
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications