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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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