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A Culturally Appropriate Intervention for Preventing and Reducing Postpartum Depression

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ClinicalTrials.gov Identifier: NCT02862444
Recruitment Status : Unknown
Verified July 2016 by Clalit Health Services.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by (Responsible Party):
Clalit Health Services

Brief Summary:

Postpartum depression (PPD) is a highly prevalent and serious mental health problem and is defined as the most recent episode of depression occurring between four weeks and twelve months after childbirth. PPD has negative effects, which are usually strongest during the first six months and may decrease the quality of mother-child interaction, adversely affecting the child's behavior and emotional and cognitive development, as well as the spouse marital relationship.PPD prevalence is estimated at 10 to 20%. A recent studies among Arab-Bedouin women, reported 31% - 43 of PPD.

Aims: To develop and implement a culturally appropriate intervention program by using focus group (FGs) methodology

Methods and Research program description: The study includes two phases. First, qualitative study will be conducted by using focus groups (FGs) method and based on the results of this phase we will develop a culturally based program. The second phase will include implementation and evaluation of the effectiveness of a culturally appropriate intervention.


Condition or disease Intervention/treatment
Postpartum Depression Other: Culturally Appropriate Intervention

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 382 participants
Time Perspective: Prospective
Official Title: The Effectiveness of a Culturally Appropriate Intervention for Preventing and Reducing Postpartum Depression Among Arab Women in Southern Israel
Study Start Date : August 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
intervention group
Culturally Appropriate Intervention
Other: Culturally Appropriate Intervention
Women in the intervention arm will receive a culturally appropriate intervention that will be provided to them according to the five strategies of culturally appropriate interventions of Kreuter et al. (2003).




Primary Outcome Measures :
  1. Postpartum depression will be measured by Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 2016-2018 ]
    Postpartum depression will be measured by Edinburgh Postnatal Depression Scale (EPDS), which was used to identify the high-risk cases of PPD. The EPDS is a ten-item self-rating scale designed to identify PPD and it is widely used in primary care settings. Each item is scored on a three-point scale (from zero to three points), the minimum and maximum total score ranging from 0 to 30, respectively. A score of thirteen and over was found to be the optimal cut-off score for probable major depression. It is accepted to use a score of ten to twelve to indicate low to moderate PPD and a score of ≥13 to indicate probable major PPD.



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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study includes two phases. First, qualitative study will be conducted by using focus groups (FGs) method and based on the results of this phase the investigators will develop a culturally based program. The second phase will include implementation and evaluation of the effectiveness of a culturally appropriate intervention.
Criteria

Inclusion and exclusion criteria

The study first phase (FGs): will include Arab Bedouin women in southern Israel, aged 18 and over who have experienced childbirth or/and who described themselves as experienced PPD symptoms in the past, could converse in Arabic, are ready to participate in group discussion and could physically attend the group's meetings.

The study second phase (RCT):

Inclusion criteria:

  • Arab Bedouin women in southern Israel
  • 26-40 weeks of pregnancy
  • Without a severe psychiatric or other health condition needing intensive care.

Exclusion criteria:

  • Women who do not speak Arabic
  • Women who are not of Arab origin
  • Women with a severe psychiatric or other health condition needing intensive care

Responsible Party: Clalit Health Services
ClinicalTrials.gov Identifier: NCT02862444     History of Changes
Other Study ID Numbers: 0004-16-COM2
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications