Antenatal Depression Help-seeking Trial in Eswatini

Help-Seeking Behavior Clinical Trial

— ADHS-RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06390735
• Other study ID #: N202312058
• Secondary ID: EHHRRB 194/2023
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Taipei Medical University
• Contact: Lindelwa Portia Dlamini, MSc
• Phone: +268 78369828
• Email: ndedlamini[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antenatal Depression
• Depression
• Depressive Disorder
• Help-Seeking Behavior

Intervention

Behavioral:
• Mommy ReachOut Intervention
The momy reachOut intervention is a web-based psycho-education with 4 sessions, released over a two week period.

Locations

Country	Name	City	State
Swaziland	King Sobhuza II Public Health Unit	Manzini
Swaziland	Mbabane Government Public Health Unit	Mbabane	Hhohho

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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