Antenatal Depression Help-seeking Trial in Eswatini

NCT06390735 | Recruiting DMC

• 2 other identifiers: N202312058EHHRRB 194/2023
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Help-Seeking Behavior; Help-seeking Intention; Antenatal Depression

Keywords

antenatal depression; Web-based interventions; Psychoeducation; RCT; Eswatini; Help-seeking

Outcome Measures

Primary Outcomes (2)

• Help-seeking Intention

  General Help Seeking Questionnaire - This 9 item scale adopted a 3 point Likert scale (Unlikely, maybe, Likely) to measure help-seeking intention. The total score is computed by summing up all item scores, where a higher score indicates higher help-seeking intention. The total possible score ranges from 9 to 27.

  Baseline; Immediately post intervention; follow-up at 1 month post intervention

• Help-seeking Behavior

  Actual Help Seeking Questionnaire - This 9 item scale uses binary responses (Yes or No) to measure actual help-seeking behavior. The total score is computed by summing up all item scores, where a higher score indicates higher help-seeking behavior. The total possible score ranges from 0 to 9.

  Baseline; Immediately post intervention; follow-up at 1 month post intervention

Secondary Outcomes (4)

• Antenatal depressive symptoms

  Baseline; Immediately post intervention; follow-up at 1 month post intervention

• Health belief

  Baseline; Immediately post intervention; follow-up at 1 month post intervention

• Antenatal depression Stigma

  Baseline; Immediately post intervention; follow-up at 1 month post intervention

• Depression literacy

  Baseline; Immediately post intervention; follow-up at 1 month post intervention

Study Arms (2)

Mommy ReachOut intervention

EXPERIMENTAL

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.

Behavioral: Mommy ReachOut Intervention

waitlist control

NO INTERVENTION

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.

Interventions

Mommy ReachOut Intervention BEHAVIORAL

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

Mommy ReachOut intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Antidepressants or other depression treatments
• Currently enrolled in another trial

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (2)

Mbabane Government Public Health Unit

Mbabane, Hhohho Region, H001, Eswatini

RECRUITING

King Sobhuza II Public Health Unit

Manzini, Eswatini

RECRUITING

MeSH Terms

Conditions

Help-Seeking Behavior

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

Lindelwa Portia Dlamini, MSc

CONTACT

+268 78369828; ndedlamini@gmail.com

Min-Huey Chung, PhD

CONTACT

minhuey300@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This two armed trial will include an intervention group and a waitlist control group.

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 30, 2024
• Study Start: March 25, 2024
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)