Postpartum DepressionNCT07167654
Smartphone Application to Support Mothers at Risk of Postpartum Depression
A study testing Smartphone Application in people with Postpartum Depression and Postpartum Depression (PPD), run by Jordan University of Science and Technology at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression, Postpartum Depression (PPD)
- What is being tested?
- Smartphone Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteJordan
- Study dates
- 15 Oct 2024to 12 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Smartphone Application for Mothers at High Risk for Postpartum Depression: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Postpartum depression (PPD) is a mental health condition affecting a substantial proportion of mothers during the first year after childbirth. It is characterized by depressed mood, anxiety, feelings of powerlessness or worthlessness, sleep disturbances, and, in some cases, suicidal thoughts. PPD significantly impacts maternal health, leading to physical and psychological difficulties, increased risk of harmful behaviors, social withdrawal, and challenges in performing daily caregiving responsibilities. Infants of affected mothers may experience impaired physical health, irregular sleep patterns, delays in cognitive and emotional development, poor mother-infant bonding, and difficulties initiating and maintaining breastfeeding. These outcomes underscore the importance of early identification and evidence-based interventions.
Psychological interventions, including psychotherapy, support groups, and cognitive-behavioral therapy (CBT), are effective in mitigating PPD symptoms by helping mothers understand their condition, manage negative thoughts, and develop adaptive coping mechanisms. Traditionally, these interventions are delivered face-to-face, providing personal interaction and emotional support. However, multiple barriers, such as socioeconomic limitations, cultural differences, provider bias, time constraints, and limited access in rural or remote areas, often restrict participation in conventional services.
To overcome these barriers, interventions are increasingly delivered remotely through smartphone applications, telephone counseling, and video conferencing platforms. Such approaches offer scalable, flexible, and culturally sensitive options for providing psychological support, particularly to underserved populations. Smartphone applications have shown promise in delivering health education, CBT-based modules, social support, and self-care strategies, with evidence suggesting effectiveness in reducing PPD symptoms in diverse international contexts. Nonetheless, the applicability and outcomes of these interventions in Middle Eastern settings, including Jordan, remain under-investigated.
In Jordan, limited postpartum discharge education and counseling present additional challenges to maternal mental health. Many mothers receive minimal guidance before leaving healthcare facilities, highlighting the need for alternative strategies to support postpartum well-being. At the same time, widespread smartphone access-including in rural communities-offers a feasible platform for delivering interventions that address gaps in education, support, and mental health care.
Given the limited research on smartphone-based interventions for PPD in Arab populations, this study aims to evaluate the effectiveness of a smartphone application specifically designed to support mothers experiencing postpartum depressive symptoms. The study will provide preliminary evidence to inform the potential implementation of scalable digital interventions in Jordan and similar contexts, contributing to improved maternal and infant health outcomes.
- Conditions
- Postpartum Depression, Postpartum Depression (PPD)
- Being tested
- Smartphone Application
- Keywords
- Smartphone Application, psychological interventions, E-Health, postpartum depression, RCT
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone ApplicationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Smartphone Application |
| Control group | No intervention | Control Group who received the routine care for postpartum mothers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks per participant (from baseline assessment at 6-8 weeks postpartum to follow-up at 3 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start15 Oct 2024
- Primary completion15 Jan 2025
- Study completion12 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Ali, Yarmouk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167654
- Sponsor's protocol ID
- Yarmouk University
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Smartphone Application for Mothers at High Risk for Postpartum Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07167654
- Acronym / sponsor ID
- Yarmouk University
- Conditions
- Postpartum Depression, Postpartum Depression (PPD)
- Keywords
- Smartphone Application, psychological interventions, E-Health, postpartum depression, RCT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 12 Sep 2025 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postpartum depression (PPD) is a mental health condition affecting a substantial proportion of mothers during the first year after childbirth. It is characterized by depressed mood, anxiety, feelings of powerlessness or worthlessness, sleep disturbances, and, in some cases, suicidal thoughts. PPD significantly impacts maternal health, leading to physical and psychological difficulties, increased risk of harmful behaviors, social withdrawal, and challenges in performing daily caregiving responsibilities. Infants of affected mothers may experience impaired physical health, irregular sleep patterns, delays in cognitive and emotional development, poor mother-infant bonding, and difficulties initiating and maintaining breastfeeding. These outcomes underscore the importance of early identification and evidence-based interventions.
Psychological interventions, including psychotherapy, support groups, and cognitive-behavioral therapy (CBT), are effective in mitigating PPD symptoms by helping mothers understand their condition, manage negative thoughts, and develop adaptive coping mechanisms. Traditionally, these interventions are delivered face-to-face, providing personal interaction and emotional support. However, multiple barriers, such as socioeconomic limitations, cultural differences, provider bias, time constraints, and limited access in rural or remote areas, often restrict participation in conventional services.
To overcome these barriers, interventions are increasingly delivered remotely through smartphone applications, telephone counseling, and video conferencing platforms. Such approaches offer scalable, flexible, and culturally sensitive options for providing psychological support, particularly to underserved populations. Smartphone applications have shown promise in delivering health education, CBT-based modules, social support, and self-care strategies, with evidence suggesting effectiveness in reducing PPD symptoms in diverse international contexts. Nonetheless, the applicability and outcomes of these interventions in Middle Eastern settings, including Jordan, remain under-investigated.
In Jordan, limited postpartum discharge education and counseling present additional challenges to maternal mental health. Many mothers receive minimal guidance before leaving healthcare facilities, highlighting the need for alternative strategies to support postpartum well-being. At the same time, widespread smartphone access-including in rural communities-offers a feasible platform for delivering interventions that address gaps in education, support, and mental health care.
Given the limited research on smartphone-based interventions for PPD in Arab populations, this study aims to evaluate the effectiveness of a smartphone application specifically designed to support mothers experiencing postpartum depressive symptoms. The study will provide preliminary evidence to inform the potential implementation of scalable digital interventions in Jordan and similar contexts, contributing to improved maternal and infant health outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Smartphone ApplicationThe 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. |
| Control group | No intervention | –Control Group who received the routine care for postpartum mothers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone ApplicationThe 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 | Other | Intervention group |
Primary outcome
The primary outcome is the symptoms of PPD measured by the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 12 weeks per participant (from baseline assessment at 6-8 weeks postpartum to follow-up at 3 months postpartum)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Application in people with Postpartum Depression and Postpartum Depression (PPD), run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the symptoms of PPD measured by the Edinburgh Postnatal Depression Scale (EPDS) (time frame: 12 weeks per participant (from baseline assessment at 6-8 weeks postpartum to follow-up at 3 months postpartum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.