Clinical trial NCT04694261: Development and Evaluation of SM-ART Intervention (SM-ART)
Official title: Resilience, Depression And Anxiety Among Pregnant Women In Pakistan: Development And Testing Of Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Resilience
Anxiety
Marital Conflict
Keywords: Resilience
Perinatal mental health
Depression
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2021-01-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The assessments will be carried out parallel in the intervention and the control arm.
Primary purpose: PREVENTION

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.

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

Eligibility criteria: Inclusion Criteria:

1. All participants should provide written consent, be 18+ years of age
2. All participants should be currently married at a gestational age of 12 to 30 weeks: by 12th week, pregnancy is confirmed, they do visit health clinic and upper bar is set to 30 weeks so there should be adequate time to provide the intervention and observe the effectiveness.
3. Participants should speak and understand urdu, as all our assessments and intervention will be in local language.

Exclusion Criteria:

Participants with a history of mental illness and/or physical illness will be excluded as will those taking antianxiety, antidepressant, anti psychotic medication.

Primary outcomes:
measure: Change in Resilience Score
timeFrame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Secondary outcomes:
measure: Change in Depression score
timeFrame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
measure: Change in Pregnancy related Anxiety score
timeFrame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
measure: Change in Marital Adjustment score
timeFrame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Koohi Goth Women Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University School of Nursing & Midwifery
name: Shireen S Bhamani, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Olivier Degomme
role: STUDY_CHAIR
affiliation: University Ghent
name: An-Sofie Van Parys
role: STUDY_DIRECTOR
affiliation: Aga Khan University
name: David Arthur
role: STUDY_DIRECTOR
References: