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NCT Number: NCT04694261

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

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.

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Key information

Conditions

Perinatal Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Marital Conflict Mental Disorders Resilience

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Koohi Goth Women Hospital

Karachi, Sindh, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants should provide written consent, be 18+ years of age
  • 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.
  • 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.

Treatment and study plan

SM-ART

Behavioral

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.

Primary outcomes

  1. Change in Resilience Score

    Time frame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

    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.

Secondary outcomes

  1. Change in Depression score

    Time frame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

    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.

  2. Change in Pregnancy related Anxiety score

    Time frame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

    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.

  3. Change in Marital Adjustment score

    Time frame: Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

    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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Acronym: SM-ART

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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