Anxiety Clinical Trial
— SM-ARTOfficial title:
Resilience, Depression And Anxiety Among Pregnant Women In Pakistan: Development And Testing Of Intervention
Verified date | February 2022 |
Source | Aga Khan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 31, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Koohi Goth Women Hospital | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University | University Ghent |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 a=.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) | |
Secondary | Change in Pregnancy related Anxiety score | Pregnancy-related anxiety scale-revised, (10 items; range 10-40; Cronbach's a=.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) | |
Secondary | 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) |
Status | Clinical Trial | Phase | |
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