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.
Status | Not yet recruiting |
Enrollment | 382 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 40 Years |
Eligibility |
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Clalit Health Services | Ben-Gurion University of the Negev |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2016-2018 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06348316 -
Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies
|
N/A | |
Completed |
NCT05322161 -
Yoga in the NICU for Parents Study
|
N/A | |
Withdrawn |
NCT03709004 -
Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression
|
N/A | |
Completed |
NCT06305325 -
Coparenting Intervention to Prevent Postpartum Depression
|
N/A | |
Not yet recruiting |
NCT05055674 -
The Effects of Motherly on Postpartum Depression
|
N/A | |
Enrolling by invitation |
NCT02323152 -
PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK
|
N/A | |
Not yet recruiting |
NCT01658098 -
Prevalence of Postpartum Depression in Hospital Jose E. Gonzalez
|
N/A | |
Completed |
NCT00961402 -
The Effect of Exercise on Preventing PostPartum Depression
|
Phase 2 | |
Completed |
NCT01312883 -
Mothers Avoiding Depression Through Empowerment Intervention Trial
|
N/A | |
Completed |
NCT00360204 -
Improving Health Outcomes for New Mothers and Babies
|
Phase 3 | |
Unknown status |
NCT00548743 -
Translating Research Into Practice for Postpartum Depression
|
N/A | |
Completed |
NCT04146025 -
Nurtured in Nature
|
N/A | |
Not yet recruiting |
NCT06442774 -
MamaConecta: Digital Tool for Maternal Mental Health
|
N/A | |
Recruiting |
NCT05137925 -
Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum
|
N/A | |
Not yet recruiting |
NCT05299398 -
Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone
|
Phase 1 | |
Completed |
NCT04925765 -
Virtual Reality Biofeedback for Postpartum Anxiety and Depression
|
N/A | |
Recruiting |
NCT06053515 -
Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication
|
N/A | |
Completed |
NCT04037085 -
Ketamine to Improve Recovery After Cesarean Delivery - Part 1
|
Phase 2 | |
Completed |
NCT05059600 -
A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting
|
Phase 4 | |
Completed |
NCT06136520 -
The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression
|
N/A |