NCT07167654

Brief Summary

Effectiveness of a Smartphone Application for Mothers at High Risk for Postpartum Depression: A Randomized Controlled Trial Abstract Aim: This study aims to determine the effectiveness of a smartphone application in reducing symptoms of postpartum depression among Jordanian women. Background: Postpartum depression (PPD) is a serious mental health condition affecting an estimated 14-27% of mothers and negatively impacting infant health. Social support and certain psychological therapies have been shown to reduce depressive symptoms in postpartum women. Smartphone applications may provide a viable means of delivering psychological interventions to mothers experiencing such symptoms. Method: A randomized controlled trial will be conducted at two maternal and child health clinics in Irbid, Jordan. A total of 295 women will be invited to participate and will be asked to provide sociodemographic data and complete the Edinburgh Postnatal Depression Scale (EPDS) at 6-8 weeks (baseline) and again at 3 months postpartum. Women with a depressive symptom score of ≥13 (n ≈ 79) will be randomly assigned to either the intervention group (n ≈ 58) or the control group (n ≈ 57). The intervention will involve an Android smartphone application called Serene Motherhood, which will enable mothers to access evidence-based cognitive techniques and health information at any time.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

August 30, 2025

Last Update Submit

September 10, 2025

Conditions

Keywords

Smartphone Applicationpsychological interventionsE-Healthpostpartum depressionRCT

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the symptoms of PPD measured by the Edinburgh Postnatal Depression Scale (EPDS)

    The EPDS is a self-administered questionnaire consisting of ten items, with a total scoring range of 0 to 30 (Cox et al., 1987). Responses are rated on a 4-point scale (0, 1, 2, or 3) according to the severity of symptoms. Items 3, 5, and 10 are reverse-scored (i.e., 3, 2, 1, and 0). The total score is obtained by summing the scores for all ten items, after reversing the coding of negatively worded items, in accordance with the scoring guidelines to ensure consistency.

    12 weeks per participant (from baseline assessment at 6-8 weeks postpartum to follow-up at 3 months postpartum)

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention was an Android smartphone application called "Serene Motherhood," which enabled mothers to access evidence-based therapeutic cognitive techniques and health information at any time.

Other: Smartphone Application

Control group

NO INTERVENTION

Control Group who received the routine care for postpartum mothers

Interventions

The Intervention: "Serene Motherhood" Application The "Serene Motherhood" application was a newly developed Android-based application created specifically for this study by the research team in collaboration with professional software developers. The content was adapted from authoritative guidelines provided by the American College of Obstetricians and Gynecologists (ACOG), the National Institute for Health and Care Excellence (NICE), the World Health Organization, and the American Psychological Association (APA, 2023; Mota \& Bø, 2021; NICE, 2016; WHO, 2022). The application was developed using the research project budget and was provided free of charge to all participants. The app aimed to integrate emotional and behavioral strategies, social support, and education for women with symptoms of PPD. The application combines evidence-based therapeutic techniques with user-friendly features supporting daily engagement with the app and self-management. Content and activities were grounded

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe only eligible self-identified gender is Female.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Jordanian women aged 18 to 45 years.
  • Primigravida or multigravida
  • Able to speak and read Arabic
  • Between six and eight weeks postpartum
  • EPDS score of ≥13
  • Access to an Android-compatible smartphone

You may not qualify if:

  • Complications during or after childbirth
  • Newborn death or need for special/intensive care
  • Positive response ("yes") to the suicidal ideation item on the EPDS (these participants will be referred to the Prince Basma Outpatient Clinics, Mental Health Department)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibn Sina and Hawara Healthcare center

Irbid, 566, Jordan

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 11, 2025

Study Start

October 15, 2024

Primary Completion

January 15, 2025

Study Completion

September 12, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to the sensitive nature of personal and health information related to maternal mental health, which could compromise participant privacy and confidentiality. Only aggregated, de-identified results will be reported.

Locations