Perinatal DepressionCoronaVirusNCT04594525
Maternal Telemental Health Interventions in Response to Covid-19*
A study testing Low-Intensity Psychosocial Interventions through Telemental health in people with Perinatal Depression and Specific Phobia, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Perinatal Depression, Specific Phobia, Perinatal Anxiety
- What is being tested?
- Low-Intensity Psychosocial Interventions through Telemental health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteQatar
- Study dates
- 5 Sep 2021to 27 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Perinatal Depression, Specific Phobia, Perinatal Anxiety
- Being tested
- Low-Intensity Psychosocial Interventions through Telemental health
- Keywords
- Telepsychiatry, Maternal Mental Health, low-intensity psychosocial interventions
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Psychosocial Interventions through Telemental healthOther
Also called WHO-Low intensity psychosocial Interventions
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: During the postnatal phase (8-10 months after birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start5 Sep 2021
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Why it stopped: Principle investigator stopped the study as number of withdrawn participants was high so it couldnt be completed to postpartum period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594525
- Sponsor's protocol ID
- MRC-05-087
- Acronym
- CoronaVirus
- Status last verified
- Feb 2024
- First submitted
- 12 Oct 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36606005Naja 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.
PubMed 34099007
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-intensity Psychosocial Interventions in Pregnant Women in Response to COVID-19: Maternal Mental Health Matters An Interventional Study
- ClinicalTrials.gov ID
- NCT04594525
- Acronym / sponsor ID
- CoronaVirus / MRC-05-087
- Conditions
- Perinatal Depression, Specific Phobia, Perinatal Anxiety
- Keywords
- Telepsychiatry, Maternal Mental Health, low-intensity psychosocial interventions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principle investigator stopped the study as number of withdrawn participants was high so it couldnt be completed to postpartum period.
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Perinatal women receiving Low intensity psychosocial interventions | Experimental | Other: Low-Intensity Psychosocial Interventions through Telemental healthOne Arm (Intervention): Will receive baseline assessment (personal characteristics) and standard psychological distress screening tools Plus WHO-low intensity psychological 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Psychosocial Interventions through Telemental healthAlso: WHO-Low intensity psychosocial InterventionsLow-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 | Perinatal women receiving Low intensity psychosocial interventions |
Primary outcome
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
Results and safety
The study was stopped early (reason given: Principle investigator stopped the study as number of withdrawn participants was high so it couldnt be completed to postpartum period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 36606005Naja 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.
- Derived from this study: PubMed 34099007Naja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Psychosocial Interventions through Telemental health in people with Perinatal Depression and Specific Phobia, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principle investigator stopped the study as number of withdrawn participants was high so it couldnt be completed to postpartum period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594525, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.