Antenatal Depression Help-seeking Trial in Eswatini

NCT ID: NCT06390735

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this trial to test if a web-based psychoeducation will work in improving depression help-seeking intention and behavior among antenatal women with probable depression in Eswatini. The main question it aims to answer is:

• Does the web-based psychoeducation improve depression help-seeking intention and help-seeking behavior in antenatal women with probable depressive symptoms?

Researchers will compare this web-based psychoeducation to a waitlist control, to see if the program works in improving depression help-seeking intention and behavior during pregnancy.

* The psychoeducation program will have a total of 4 sessions, which will be given to participants over a two-week period. two sessions will be delivered each week.
* Participants will be asked questions before the intervention starts, immediately the intervention ends as well as after a month of completing the intervention.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Help-Seeking Behavior Help-seeking Intention Antenatal Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This two armed trial will include an intervention group and a waitlist control group.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mommy ReachOut intervention

The intervention group will receive the Mommy ReachOut intervention, which is a web-based psychoeducation, consisting of a total of 4 sessions to be released over a 2-week period. Two sessions will be released each week, with each session consisting of readable mental health information and videos. Content for this intervention was based on previous reviews, previous intervention studies and the Diagnostic and Statistical manual of mental health disorders (DSM-5). Session content included basic information about antenatal depression, shared antenatal depression experiences, issues around stigma towards antenatal depression, and local resources available for antenatal women with depression in Eswatini.

Group Type EXPERIMENTAL

Mommy ReachOut Intervention

Intervention Type BEHAVIORAL

The momy reachOut intervention is a web-based psycho-education with 4 sessions, released over a two week period.

waitlist control

Participants in the control group will have access to the active treatment after completing the 6-week waiting period. Once the control participants complete the 1-month follow-up assessment, they will receive a website link to access the complete Mommy ReachOut intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mommy ReachOut Intervention

The momy reachOut intervention is a web-based psycho-education with 4 sessions, released over a two week period.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Less than 30 weeks of gestation,
* Aged 18 or above
* With probable depression (Edinburg Postnatal depression scale; EPDS \> 10)
* Has access to a smart phone
* Fluent in spoken and written Siswati or English (with at least secondary school education)
* Planning to remain in the country for the next 2 months
* Willing to share her dominant phone number with the study team
* Willing to participate in the intervention study

Exclusion Criteria

* Antidepressants or other depression treatments
* Currently enrolled in another trial
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lindelwa Portia Dlamini

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mbabane Government Public Health Unit

Mbabane, Hhohho Region, Eswatini

Site Status RECRUITING

King Sobhuza II Public Health Unit

Manzini, , Eswatini

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Eswatini

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lindelwa Portia Dlamini, MSc

Role: CONTACT

+268 78369828

Min-Huey Chung, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lindelwa P. Dlamini, MSc

Role: primary

+268 78369828

Lindelwa P. Dlamini, MSc.

Role: primary

+268 78369828

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EHHRRB 194/2023

Identifier Type: OTHER

Identifier Source: secondary_id

N202312058

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mindful Moms Randomized Control Trial
NCT04886856 RECRUITING NA