Low-intensity Psychosocial Interventions in Pregnant Women in Response to COVID-19: Maternal Mental Health Matters An Interventional Study

Hamad Medical Corporation2 个研究点分布在 1 个国家目标入组 58 人开始时间: 2021年9月5日最近更新: 2024年3月22日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方: Hamad Medical Corporation
入组人数: 58
试验地点: 2
主要终点: Change (T3-T2) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 2-4 months postnatal (T3)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the effectiveness of a telemental health intervention on the mental health of pregnant women during the COVID-19 crisis in Qatar.

详细描述

A list of potential participants, including contact information, will be extracted from Women Wellness and Research Center's registry. A probability sampling technique (simple random selection) will be employed to randomly select (Automated Random Number Generator) the potential participants. Then, the potential participants will be contacted and informed about the study. After consenting to participate, they will be screened for eligibility. The pregnant women who met the inclusion criteria will be enrolled and followed up until nine months after delivery. The contact details of each participant will be written on a paper and sealed in an envelope marked with either letter A or B. Upon enrolment, the participants will be randomized equally with a block size of two into two parallel arms. The pregnant women in the interventional arm will receive six sessions of a low-intensity psychosocial intervention through telemental health consultations with a trained psychologist. On the other hand, those in the control arm will not receive any intervention. The participants in both arms will be screened for psychological distress (six times) over the study period.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Outcomes Assessor)

盲法说明

Blinding to data entry means a unique code will be allocated to each subject before entering the data for the analysis.

入排标准

年龄范围: 18 Years 至 49 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•All pregnant women of reproductive age (18- 49) years old in the second trimester that agree and consent to receive teleconsultation.
•No specific nationality restriction.
•Language communicated English and Arabic.
•Able to cooperate with data collection procedure.

排除标准

•Pregnant women with psychiatric illness and following up at Sidra or HMC mental services.
•Pregnant women receiving mental health medications (antidepressants.)
•Cannot communicate in English or Arabic.
•Didn't consent.

结局指标

主要结局

Change (T3-T2) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 2-4 months postnatal (T3)

时间窗: During the postnatal phase (2-4 months after birth)

The EPDS-10 is a validated (English and Arabic versions) instrument that assesses perinatal depression. It consists of ten questions. The total score will range from zero (no depression) to 30 (severe depression).

Baseline (T0) perinatal depression through the 10-points Edinburgh Postnatal Depression (Scale (EPDS-10)

时间窗: Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation)

Change (T5-T4) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 8-10 months postnatal (T5)

时间窗: During the postnatal phase (8-10 months after birth)

Baseline (T0) Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire

时间窗: Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation)

The Covid-9 Specific phobia questionnaire consists of seven items (five-item Likert-type scale). The answers include "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree". A total score is calculated ranging from 7 to 35. The higher the score, the greater the fear of cororonavirus-19.

Change (T1-T0) from baseline perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at third trimester (T1)

时间窗: During the third trimester (Beginning of the 28th week till end of 42nd week of gestation)

Change (T1-T0) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at third trimester (T1)

时间窗: During the third trimester (Beginning of the 28th week till end of 42nd week of gestation)

Change (T3-T2) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 2-4 months after birth (T3)

时间窗: During the postnatal phase (2-4 months after birth)

Change (T2-T1) from third trimester perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 3-5 weeks postnatal (T2)

时间窗: During the postnatal phase (3-5 weeks after birth)

Change (T4-T3) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 5-7 months postnatal (T4)

时间窗: During the postnatal phase (5-7 months after birth)

Change (T2-T1) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 3-5 weeks after birth (T2)

时间窗: During the postnatal phase (3-5 weeks after birth)

Change (T4-T3) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 5-7 months after birth (T4)

时间窗: During the postnatal phase (5-7 months after birth)

Baseline (T0) perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3)

时间窗: Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation)