Postpartum Depression Clinical Trial
Official title:
The Effectiveness of a Culturally Appropriate Intervention for Preventing and Reducing Postpartum Depression Among Arab Women in Southern Israel
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.
This study main aim has two aims:
1. To develop and implement a culturally appropriate intervention program by using focus
group (FGs) methodology.
2. To evaluate the effectiveness of the culturally appropriate program in preventing PPD
among Arab Bedouin women in southern Israel, while taking into consideration different
factors.
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 the investigators will develop a culturally based program. The second phase will
include implementation and evaluation of the effectiveness of a culturally appropriate
intervention.
The study first phase Developing a culturally appropriate intervention using focus groups
(FGs) At this phase we will conduct four focus groups. Focus Group questions will be
designed to encourage participant interaction, and to elicit information relevant to our
study aims regarding methods of preventing and reducing PPD among Bedouin women. Three focus
groups will take place in the morning as most women do not work. One focus groups will be
conducted in the afternoon hours for women who work outside the household.
At the beginning of each FG, the participants will sign an informed consent form, in
addition each participant will be asked to complete an anonymous, short demographic
questionnaire.
The study second phase Evaluation of the effectiveness of culturally appropriate
intervention to prevent PPD. As mentioned above the intervention program will be based on
the findings of the FG in the first phase and will take approximately six to nine months and
will be conducted in the Arabic language by an Arab research team from the same culture.
Data collection: During the year 2016, women who visit a gynecologist in the women's health
center of Clalit in Rahat, Laqqya and Segev-Shalom will be approached by the PhD student and
asked to participate in the study.
All women in the intervention and control groups will be screened for PPD symptoms and
interviewed face-to-face before the intervention (during pregnancy, beginning at week of
26), four to six weeks postpartum and during three to six months postpartum using a
structured questionnaire in Arabic, which will include questions on PPD symptoms, knowledge
and attitudes about PPD, and use of mental health care services.
Then group training will be carried out for postpartum women in the intervention arm only.
The interviews will be carried out by the PhD student and other trained female students.
A structured questionnaire in Arabic will be administered, and will include questions on
knowledge and attitudes about PPD, PPD symptoms, IPV, self-assessment of health status,
chronic diseases and lifestyle behaviors, socio-demographic, socio-economic, and
psychological characteristics, obstetrical factors, and use of mental health care services
for PPD.
The duration of each interview will be thirty minutes, and the interviews will be conducted
in Arabic. Women who report EPDS score of ≥10 will be referred to a family physician, social
worker, psychologist and/or a psychiatrist. Question ten on the EPDS refers to thoughts of
self-harm, and any positive answer is considered a cause for concern, which means that women
who reply positively to question ten, regardless of their EPDS score, will be referred to
the nearest mental health service and women that suffer a sever psychiatric condition
needing intensive care will be dropped from the study. All women needing help and
professional psychiatric counseling will be referred to Dr. Awad-Alktnani, psychiatrist from
the same population, which works in Rahat and Soroka Medical Center in Be'er-Sheva, and one
of the researchers in the current study.
The study instruments The study instruments will be in Arabic and it will include validated
scales and questions that were used in previous research among Arab women in Israel and in
Arab countries.
Privacy and Confidentiality of participants and data The first phase of the study: data will
be collected anonymously, questionnaires will be saved by the researchers at the university.
In the second phase of the study: participants will sign an informed consent form which
include name, social security number, telephone number and a serial number. Informed consent
forms will be saved by researchers in Ben-Gurion University in a closed and locked place.
Research tools (questionnaires) will include a serial number only, with no Identifying
details of the participants. These questionnaires will also be saved at the university but
not in the same folder of the Informed Consent Forms.
For performing statistical analysis: Data will be typed and stored on a computer without
identifying details.
Data analysis and statistical methods Statistical analysis of the second phase of the study
will be performed using the SPSS statistical software version 20.
Ethical aspects The study (both phases) will start only after approval of the Clalit Health
services and Ethics Committee approval
;
Time Perspective: Prospective
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