Clinical trial NCT04594525: Maternal Telemental Health Interventions in Response to Covid-19*
Official title: Low-intensity Psychosocial Interventions in Pregnant Women in Response to COVID-19: Maternal Mental Health Matters An Interventional Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Perinatal Depression
Specific Phobia
Perinatal Anxiety
Keywords: Telepsychiatry
Maternal Mental Health
low-intensity psychosocial interventions
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline (T0) perinatal depression through the 10-points Edinburgh Postnatal Depression (Scale (EPDS-10)
timeFrame: Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation)
measure: Change (T1-T0) from baseline perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at third trimester (T1)
timeFrame: During the third trimester (Beginning of the 28th week till end of 42nd week of gestation)
measure: Change (T2-T1) from third trimester perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 3-5 weeks postnatal (T2)
timeFrame: During the postnatal phase (3-5 weeks after birth)
measure: Change (T3-T2) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 2-4 months postnatal (T3)
timeFrame: During the postnatal phase (2-4 months after birth)
measure: Change (T4-T3) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 5-7 months postnatal (T4)
timeFrame: During the postnatal phase (5-7 months after birth)
measure: Change (T5-T4) in perinatal depression on the 10-points Edinburgh Postnatal Depression Scale (EPDS-10) at 8-10 months postnatal (T5)
timeFrame: During the postnatal phase (8-10 months after birth)
measure: Baseline (T0) Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire
timeFrame: Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation)
measure: Change (T1-T0) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at third trimester (T1)
timeFrame: During the third trimester (Beginning of the 28th week till end of 42nd week of gestation)
measure: Change (T2-T1) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 3-5 weeks after birth (T2)
timeFrame: During the postnatal phase (3-5 weeks after birth)
measure: Change (T3-T2) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 2-4 months after birth (T3)
timeFrame: During the postnatal phase (2-4 months after birth)
measure: Change (T4-T3) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 5-7 months after birth (T4)
timeFrame: During the postnatal phase (5-7 months after birth)
measure: Change (T5-T4) in Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire at 8-10 months after birth (T5)
timeFrame: During the postnatal phase (8-10 months after birth)
measure: Baseline (T0) perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3)
timeFrame: Baseline in their second trimester (Beginning of 14th week till end of 27th week of gestation)
measure: Change (T1-T0) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at third trimester (T1)
timeFrame: During the third trimester (Beginning of the 28th week till end of 42nd week of gestation)
measure: Change (T2-T1) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 3-5 weeks after birth (T2)
timeFrame: During the postnatal phase (3-5 weeks after birth)
measure: Change (T3-T2) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 2-4 months after birth (T3)
timeFrame: During the postnatal phase (2-4 months after birth)
measure: Change (T4-T3) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 5-7 months after birth (T4)
timeFrame: During the postnatal phase (5-7 months after birth)
measure: Change (T5-T4) in perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3) at 8-10 months after birth (T5)
timeFrame: During the postnatal phase (8-10 months after birth)
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: HMC
Study officials:
References:
citation: Naja S, Elyamani R, Chehab M, Siddig M, Al Ibrahim A, Mohamad T, Singh R, Bougmiza I. Maternal low-intensity psychosocial telemental interventions in response to COVID-19 in Qatar: study protocol for a randomized controlled trial. Trials. 2021 Jun 7;22(1):382. doi: 10.1186/s13063-021-05339-w.