Postpartum DepressionNCT02862444
A Culturally Appropriate Intervention for Preventing and Reducing Postpartum Depression
An observational study of Postpartum Depression, run by Clalit Health Services.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Culturally Appropriate Intervention
- How many people
- 382 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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):
- Arab Bedouin women in southern Israel
- 26-40 weeks of pregnancy
- Without a severe psychiatric or other health condition needing intensive care.
Who cannot join
- 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
About this study
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.
Read the detailed description
This study main aim has two aims:
- To develop and implement a culturally appropriate intervention program by using focus group (FGs) methodology.
- 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
- Conditions
- Postpartum Depression
- Being tested
- Culturally Appropriate Intervention
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Appropriate InterventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Culturally Appropriate Intervention Receives: Other: Culturally Appropriate Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum depression will be measured by Edinburgh Postnatal Depression Scale (EPDS)
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.
Measured: 2016-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862444
- Sponsor's protocol ID
- 0004-16-COM2
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Alfayumi-Zeadna S, Zeadna A, Azbarga Z, Salman L, Froimovici M, Alkatnany A, Grotto I, Daoud N. A Non-Randomized Controlled Trial for Reducing Postpartum Depression in Low-Income Minority Women at Community-Based Women's Health Clinics. Matern Child Health J. 2022 Aug;26(8):1689-1700. doi: 10.1007/s10995-022-03434-1. Epub 2022 Apr 21.
PubMed 35445883
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Culturally Appropriate Intervention for Preventing and Reducing Postpartum Depression Among Arab Women in Southern Israel
- ClinicalTrials.gov ID
- NCT02862444
- Acronym / sponsor ID
- 0004-16-COM2
- Conditions
- Postpartum Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Aug 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study main aim has two aims:
- To develop and implement a culturally appropriate intervention program by using focus group (FGs) methodology.
- 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
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Other: Culturally Appropriate InterventionCulturally Appropriate Intervention |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- Arab Bedouin women in southern Israel
- 26-40 weeks of pregnancy
- Without a severe psychiatric or other health condition needing intensive care.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Appropriate InterventionWomen 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). | Other | intervention group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Derived from this study: PubMed 35445883Alfayumi-Zeadna S, Zeadna A, Azbarga Z, Salman L, Froimovici M, Alkatnany A, Grotto I, Daoud N. A Non-Randomized Controlled Trial for Reducing Postpartum Depression in Low-Income Minority Women at Community-Based Women's Health Clinics. Matern Child Health J. 2022 Aug;26(8):1689-1700. doi: 10.1007/s10995-022-03434-1. Epub 2022 Apr 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by Clalit Health Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum depression will be measured by Edinburgh Postnatal Depression Scale (EPDS) (time frame: 2016-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.