Perinatal Anxiety, Perinatal Depression, Specific Phobia
Conditions
Keywords
Telepsychiatry, Maternal Mental Health, low-intensity psychosocial interventions
Brief summary
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
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.
Interventions
OTHERLow-Intensity Psychosocial Interventions through Telemental health
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.
Sponsors
Hamad Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding to data entry means a unique code will be allocated to each subject before entering the data for the analysis.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
1. All pregnant women of reproductive age (18- 49) years old in the second trimester that agree and consent to receive teleconsultation. 2. No specific nationality restriction. 3. Language communicated English and Arabic. 4. Able to cooperate with data collection procedure.
Exclusion criteria
1. Pregnant women with psychiatric illness and following up at Sidra or HMC mental services. 2. Pregnant women receiving mental health medications (antidepressants.) 3. Cannot communicate in English or Arabic. 4. Didn't consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (T4-T3) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 5-7 months after birth (T4) | During the postnatal phase (5-7 months after birth) | 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 (T0) perinatal depression through the 10-points Edinburgh Postnatal Depression (Scale (EPDS-10) | Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation) | 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). |
| Change (T1-T0) from baseline perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at third trimester (T1) | During the third trimester (Beginning of the 28th week till end of 42nd week of gestation) | 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). |
| Change (T2-T1) from third trimester perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 3-5 weeks postnatal (T2) | During the postnatal phase (3-5 weeks 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). |
| Change (T3-T2) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 2-4 months postnatal (T3) | 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). |
| Change (T4-T3) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 5-7 months postnatal (T4) | During the postnatal phase (5-7 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). |
| Change (T5-T4) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 8-10 months postnatal (T5) | During the postnatal phase (8-10 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) Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire | 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) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at third trimester (T1) | During the third trimester (Beginning of the 28th week till end of 42nd 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 (T2-T1) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 3-5 weeks after birth (T2) | During the postnatal phase (3-5 weeks after birth) | 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 (T3-T2) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 2-4 months after birth (T3) | During the postnatal phase (2-4 months after birth) | 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 (T4-T3) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 5-7 months after birth (T4) | During the postnatal phase (5-7 months after birth) | 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 (T5-T4) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 8-10 months after birth (T5) | During the postnatal phase (8-10 months after birth) | 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 (T0) perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) | Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation) | 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). |
| Change (T1-T0) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at third trimester (T1) | During the third trimester (Beginning of the 28th week till end of 42nd week of gestation) | 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). |
| Change (T2-T1) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 3-5 weeks after birth (T2) | During the postnatal phase (3-5 weeks after birth) | 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). |
| Change (T3-T2) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 2-4 months after birth (T3) | During the postnatal phase (2-4 months after birth) | 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). |
| Change (T5-T4) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 8-10 months after birth (T5) | During the postnatal phase (8-10 months after birth) | 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). |
Countries
Qatar
Outcome results
None listed