Development and Evaluation of SM-ART Intervention (SM-ART) (SM-ART)

Resilience, Depression And Anxiety Among Pregnant Women In Pakistan: Development And Testing Of Intervention

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Resilience; Perinatal Depression; Marital Conflict
• Intervention / Treatment: Behavioral: SM-ART

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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Koohi Goth Women Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SM-ART Intervention; Intervention group will receive SM-ART module training along with the flyers on resilience building tips.	Behavioral: SM-ART; Intervention is a group based training delivered by midwives on SM-ART module. These training will consist of 6 sessions, one per week for 90 to 120 minutes each.
NO_INTERVENTION: Control Group; Control group will only receive flyer on resilience building tips

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Resilience Score	Resilience Scale 14: This is a 14 items scale which score ranges from 14 to 98. It represent all five characteristics of resilience: A purposeful life, Perseverance, Equanimity, Self-reliance and Existential aloneness. A higher total score indicates higher resilience. The scale also have cutoffs as well. The scale is validated in Pakistani population by the current study principle investigator.	Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression score	Edinburgh Postnatal Depression Scale (EPDS):10-item; range 0-30, cut-off 13; across 15 countries including some LMIC Cronbach's α=.73-.87; 3 to 12 week test-retest=.53-.74) measures depression.	Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Change in Pregnancy related Anxiety score	Pregnancy-related anxiety scale-revised, (10 items; range 10-40; Cronbach's α=.78) evaluates feelings about health during pregnancy, health of fetus/infant, and labour and delivery.	Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Change in Marital Adjustment score	Locke Wallace Marital Adjustment Test (15 Items) It focuses on the aspects like participation in shared activities, display of affection and spouse agreement on important matters related to marital adjustment. It is an extensively used self-report measure of adjustment in marriage. The scale scores range from 2-158. A score less than 100 indicate marital distress.	Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: University Ghent
• Investigators: Principal Investigator: Shireen S Bhamani, PhD Student, Aga Khan University School of Nursing & Midwifery; Study Chair: Olivier Degomme, University Ghent; Study Director: An-Sofie Van Parys, University Ghent; Study Director: David Arthur, Aga Khan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (ACTUAL): January 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Resilience; Perinatal mental health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 5312-SON-ERC-18.; 70345 (182015SONAM) (OTHER_GRANT: University Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be analyzed using unique identifier and only the password protected data may be shared with the supervisory team of researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No