Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-30 @ 2:06 AM
Study NCT ID:
NCT04694261
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2020-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Evaluation of SM-ART Intervention (SM-ART)
Sponsor:
Aga Khan University
Organization:
Study Overview
Official Title:
Resilience, Depression And Anxiety Among Pregnant Women In Pakistan: Development And Testing Of Intervention
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SM-ART
Brief Summary:
The approach of this intended research is to help pregnant women practice constructive coping and proactive skills that focus on positive adaptation for safe motherhood through our developed intervention.
The objective of this two phases Randomized Control Trial is to develop contextually based "SM-ART" intervention \[Safe Motherhood ART: Accessible Resilience Training\] and evaluate the effectiveness of "SM-ART" intervention in a sample of pregnant women living in low socioeconomic urban areas of Karachi, Pakistan.
It is hypothesized that the SM-ART intervention will enhance resilience and marital harmony and decrease symptoms of depression, anxiety in pregnant women.
The objective of this two phases Randomized Control Trial is to develop contextually based "SM-ART" intervention \[Safe Motherhood ART: Accessible Resilience Training\] and evaluate the effectiveness of "SM-ART" intervention in a sample of pregnant women living in low socioeconomic urban areas of Karachi, Pakistan.
It is hypothesized that the SM-ART intervention will enhance resilience and marital harmony and decrease symptoms of depression, anxiety in pregnant women.
Detailed Description:
The prevalence of perinatal depression and anxiety in South Asia are among the highest in the world. In Pakistan, approximately 18% to 60% of women experienced depressive symptoms at some point during their pregnancy. Early intervention for the management of mental illness in pregnancy is imperative as the effects of perinatal mental ill-health is not only limited to mothers but also can negatively impact child health outcomes. In a public health context, positive psychological interventions should be promoted as it reduces the burden of treatment, and enhance cost effective approaches in resource poor countries such as Pakistan.
As in Pakistan, no program has been planned and tested to enhance the positive psychological wellbeing among pregnant women that is based on individual strengths, that can be learnt, sustained and low cost as well. Hence, this study aims to facilitate pregnant women in practicing constructive coping and proactive skills which will help them to focus more on the positive approach of life rather than looking for the negative situations that is carried out in their daily lives.
The study will carried out in two phases:
Phase I: The objective of phase one is study is to develop "SM-ART" intervention \[Safe Motherhood ART: Accessible Resilience Training\]
Phase II: The objective of phase two is to test the effectiveness of "SM-ART" intervention \[Safe Motherhood ART: Accessible Resilience Training\] to improve resilience, marital harmony and decrease depression and pregnancy related anxiety in a sample of pregnant women presenting to Koohi Goth Hospital of Karachi, Pakistan
As in Pakistan, no program has been planned and tested to enhance the positive psychological wellbeing among pregnant women that is based on individual strengths, that can be learnt, sustained and low cost as well. Hence, this study aims to facilitate pregnant women in practicing constructive coping and proactive skills which will help them to focus more on the positive approach of life rather than looking for the negative situations that is carried out in their daily lives.
The study will carried out in two phases:
Phase I: The objective of phase one is study is to develop "SM-ART" intervention \[Safe Motherhood ART: Accessible Resilience Training\]
Phase II: The objective of phase two is to test the effectiveness of "SM-ART" intervention \[Safe Motherhood ART: Accessible Resilience Training\] to improve resilience, marital harmony and decrease depression and pregnancy related anxiety in a sample of pregnant women presenting to Koohi Goth Hospital of Karachi, Pakistan
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 70345 (182015SONAM) | OTHER_GRANT | University Research Council | View |