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

March 21, 2024 updated by: Hamad Medical Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar, 0000
        • HMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline (T0) perinatal depression through the 10-points Edinburgh Postnatal Depression (Scale (EPDS-10)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
During the postnatal phase (8-10 months after birth)
Baseline (T0) Covid-19 Specific phobia through the Covid-19 Specific phobia questionnaire
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
During the postnatal phase (8-10 months after birth)
Baseline (T0) perinatal anxiety through a subscale of Edinburgh Postnatal Depression Scale (EPDS-3)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
During the postnatal phase (8-10 months after birth)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2021

Primary Completion (Actual)

October 27, 2021

Study Completion (Actual)

October 27, 2021

Study Registration Dates

First Submitted

October 12, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-05-087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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