Antenatal Depression Help-seeking Trial in Eswatini (ADHS-RCT)

Effectiveness of a Web-based Psychoeducation on Antenatal Depression Help-seeking in Eswatini

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.

Study Overview

• Status: Recruiting
• Conditions: Antenatal Depression; Help-Seeking Behavior; Help-seeking Intention
• Intervention / Treatment: Behavioral: Mommy ReachOut Intervention

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindelwa Portia Dlamini, MSc; Phone Number: +268 78369828; Email: ndedlamini@gmail.com
• Study Contact Backup: Name: Min-Huey Chung, PhD; Email: minhuey300@tmu.edu.tw

Study Locations

• Swaziland
  • Manzini, Swaziland
    • Recruiting
    • King Sobhuza II Public Health Unit
    • Contact: Lindelwa P. Dlamini, MSc.; Phone Number: +268 78369828; Email: ndedlamini@gmail.com
  • Hhohho
    • Mbabane, Hhohho, Swaziland, H001
      • Recruiting
      • Mbabane Government Public Health Unit
      • Contact: Lindelwa P. Dlamini, MSc; Phone Number: +268 78369828; Email: ndedlamini@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mommy ReachOut Intervention; The momy reachOut intervention is a web-based psycho-education with 4 sessions, released over a two week period.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antenatal depressive symptoms	Edinburgh Postnatal Depression Scale - A set of 10 items are used to measure antenatal depressive symptoms on a 4-point Likert scale (0-3). The overall score ranges from 0 to 30 and is computed by summing up all item scores. A high sum of scores indicates a high level of depressive symptoms.	Baseline; Immediately post intervention; follow-up at 1 month post intervention
Health belief	Theory of Planned Behavior questionnaire - The tool has 13 items that rate the constructs of the theory of planned behavior on a 5-point Likert scales (strongly disagree to strongly agree). The possible score ranges from 13 to 65, with higher scores indicating more favorable attitudes towards help-seeking, greater subjective norms to seek help, and more control over one's behavior.	Baseline; Immediately post intervention; follow-up at 1 month post intervention
Antenatal depression Stigma	Depression stigma scale - The 9 items in this scale measure personal stigma towards depression. Responses to each item are measured on a five-point Likert scale (strongly disagree to strongly agree). The total score is through summing up all item scores and a total possible score ranges from 0 to 36. A higher score indicates higher levels of personal depression stigma	Baseline; Immediately post intervention; follow-up at 1 month post intervention
Depression literacy	Depression literacy scale - The scale measures participants knowledge of the signs of depression, risk factors, and treatment among others. participants respond to each item with a true (1) or false (0), therefore, the total possible score ranges from 0 to 22. From summing up all item scores, a higher score will indicate high antenatal depression literacy.	Baseline; Immediately post intervention; follow-up at 1 month post intervention

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: RCT; Psychoeducation; antenatal depression; Eswatini; Help-seeking; Web-based interventions
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: N202312058; EHHRRB 194/2023 (Other Identifier: Eswatini Health and Human Research Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No