Maternal Telemental Health Interventions in Response to Covid-19*

NCT ID: NCT04594525

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-05
• Study Completion Date: 2021-10-27

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low-Intensity Psychosocial Interventions through Telemental health

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

WHO-Low intensity psychosocial Interventions

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HMC

Doha, , Qatar

Countries

Qatar

References

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.

Reference Type: DERIVED

PMID: 36606005 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34099007 (View on PubMed)

Other Identifiers

MRC-05-087

Identifier Type: -

Identifier Source: org_study_id