Maternal Telemental Health Interventions in Response to Covid-19*

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Perinatal Depression, Specific Phobia, Perinatal Anxiety

Intervention / Treatment
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* Other: Low-Intensity Psychosocial Interventions through Telemental health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The design of the study: Two-arm randomized controlled trial. One Arm (Intervention): Will receive baseline assessment (personal characteristics) and standard psychological distress screening tools Plus WHO-low psychological intervention. One Arm (Control): baseline assessment (personal characteristics) and standard psychological distress screening tools without the WHO-low psychological intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perinatal women receiving Low intensity psychosocial interventions<br>One Arm (Intervention): Will receive baseline assessment (personal characteristics) and standard psychological distress screening tools Plus WHO-low intensity psychological interventions through Telemental health. | Other: Low-Intensity Psychosocial Interventions through Telemental health<br>* Low-Intensity Psychosocial Interventions through Telemental health (Thinking healthy): The intervention will include six sessions. Each session may last to 45 min as a max, and it will be provided through telehealth. The first session will be an introduction, while the other five sessions will be covering the period from the second pregnancy trimester to the first year of the infant's life.<br>* Other names: WHO-Low intensity psychosocial Interventions;|
| No Intervention: Participants-Perinatal women (pregnant women and post-partum) not receiving intervention<br>One Arm (Control): baseline assessment (personal characteristics) and standard psychological distress screening tools without the WHO-low psychological intervention through Telemental health. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline (T0) perinatal depression through the 10-points Edinburgh Postnatal Depression (Scale (EPDS-10) | 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 in their second trimester (Beginning of 14th week till end of 27th week of gestation) | 
| Change (T1-T0) from baseline perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at third trimester (T1) | 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). | During the third trimester (Beginning of the 28th week till end of 42nd week of gestation) | 
| Change (T2-T1) from third trimester perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 3-5 weeks postnatal (T2) | 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). | During the postnatal phase (3-5 weeks after birth) | 
| Change (T3-T2) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 2-4 months postnatal (T3) | 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). | During the postnatal phase (2-4 months after birth) | 
| Change (T4-T3) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 5-7 months postnatal (T4) | 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). | During the postnatal phase (5-7 months after birth) | 
| Change (T5-T4) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 8-10 months postnatal (T5) | 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). | During the postnatal phase (8-10 months after birth) | 
| Baseline (T0) Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire | 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. | Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation) | 
| Change (T1-T0) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at third trimester (T1) | 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. | During the third trimester (Beginning of the 28th week till end of 42nd week of gestation) | 
| Change (T2-T1) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 3-5 weeks after birth (T2) | 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. | During the postnatal phase (3-5 weeks after birth) | 
| Change (T3-T2) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 2-4 months after birth (T3) | 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. | During the postnatal phase (2-4 months after birth) | 
| Change (T4-T3) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 5-7 months after birth (T4) | 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. | During the postnatal phase (5-7 months after birth) | 
| Change (T5-T4) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 8-10 months after birth (T5) | 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. | During the postnatal phase (8-10 months after birth) | 
| Baseline (T0) perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) | A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety). | Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation) | 
| Change (T1-T0) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at third trimester (T1) | A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety). | During the third trimester (Beginning of the 28th week till end of 42nd week of gestation) | 
| Change (T2-T1) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 3-5 weeks after birth (T2) | A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety). | During the postnatal phase (3-5 weeks after birth) | 
| Change (T3-T2) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 2-4 months after birth (T3) | A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety). | During the postnatal phase (2-4 months after birth) | 
| Change (T4-T3) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 5-7 months after birth (T4) | A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety). | During the postnatal phase (5-7 months after birth) | 
| Change (T5-T4) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 8-10 months after birth (T5) | A subscale of Edinburgh Postnatal Depression Scale (EPDS-3) will be used and includes three items of EPDS-10. The total score will range from zero (no anxiety) till nine (severe anxiety). | During the postnatal phase (8-10 months after birth) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telepsychiatry, Maternal Mental Health, low-intensity psychosocial interventions