CoronaVirus: Maternal Telemental Health Interventions in Response to Covid-19*

Sponsor
Hamad Medical Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04594525
Collaborator
(none)
58
1
2
14.9
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Low-Intensity Psychosocial Interventions through Telemental health
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (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.
Primary Purpose:
Prevention
Official Title:
Low-intensity Psychosocial Interventions in Pregnant Women in Response to COVID-19: Maternal Mental Health Matters An Interventional Study
Actual Study Start Date :
Sep 5, 2021
Actual Primary Completion Date :
Oct 27, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Perinatal women receiving Low intensity psychosocial interventions

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
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.
Other Names:
  • WHO-Low intensity psychosocial Interventions
  • No Intervention: Participants-Perinatal women (pregnant women and post-partum) not receiving intervention

    One Arm (Control): baseline assessment (personal characteristics) and standard psychological distress screening tools without the WHO-low psychological intervention through Telemental health.

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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).

    3. 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).

    4. 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).

    5. 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).

    6. 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).

    7. 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.

    8. 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.

    9. 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.

    10. 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.

    11. 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.

    12. 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.

    13. 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).

    14. 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).

    15. 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).

    16. 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).

    17. 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).

    18. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HMC Doha Qatar 0000

    Sponsors and Collaborators

    • Hamad Medical Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hamad Medical Corporation
    ClinicalTrials.gov Identifier:
    NCT04594525
    Other Study ID Numbers:
    • MRC-05-087
    First Posted:
    Oct 20, 2020
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hamad Medical Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 9, 2022