NCT04594525

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

September 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed
Last Updated

March 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

October 12, 2020

Last Update Submit

March 21, 2024

Conditions

Perinatal DepressionSpecific PhobiaPerinatal Anxiety

Keywords

TelepsychiatryMaternal Mental Healthlow-intensity psychosocial interventions

Outcome Measures

Primary Outcomes (18)

  • Baseline (T0) perinatal depression through the 10-points Edinburgh Postnatal Depression (Scale (EPDS-10)

    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)

    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)

    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)

    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)

    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)

    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

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

Study Arms (2)

Perinatal women receiving Low intensity psychosocial interventions

EXPERIMENTAL

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

Participants-Perinatal women (pregnant women and post-partum) not receiving intervention

NO INTERVENTION

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

Interventions

Low-Intensity Psychosocial Interventions through Telemental healthOTHER

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.

Also known as: WHO-Low intensity psychosocial Interventions
Perinatal women receiving Low intensity psychosocial interventions

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females in their Second Trimester
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All pregnant women of reproductive age (18- 49) years old in the second trimester that agree and consent to receive teleconsultation.
  • No specific nationality restriction.
  • Language communicated English and Arabic.
  • Able to cooperate with data collection procedure.

You may not qualify if:

  • Pregnant women with psychiatric illness and following up at Sidra or HMC mental services.
  • Pregnant women receiving mental health medications (antidepressants.)
  • Cannot communicate in English or Arabic.
  • Didn't consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HMC

Doha, 0000, Qatar

Location

Related Publications (2)

  • Naja S, Elyamani R, Chehab M, Ali Siddig Ahmed M, Babeker G, Lawand G, Singh R, Adli N, Mohamad T, Bougmiza I. The impact of telemental health interventions on maternal mental health outcomes: a pilot randomized controlled trial during the COVID-19 pandemic. Health Psychol Behav Med. 2022 Dec 28;11(1):1-21. doi: 10.1080/21642850.2022.2155167. eCollection 2023.

    PMID: 36606005DERIVED

  • 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.

    PMID: 34099007DERIVED

MeSH Terms

Conditions

Phobia, Specific

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding to data entry means a unique code will be allocated to each subject before entering the data for the analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 20, 2020

Study Start

September 5, 2021

Primary Completion

October 27, 2021

Study Completion

October 27, 2021

Last Updated

March 22, 2024

Record last verified: 2024-02

Locations

QA(1)