Postpartum DepressionLoVE4MUMNCT06366035
LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression
A study testing LoVE4MUM mobile application in people with Postpartum Depression and Maternal Behavior, run by National Institutes of Health, Ministry of Health Malaysia at 2 sites in Malaysia.
Trial summary
Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum… Read more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Maternal Behavior, mHealth Intervention
- What is being tested?
- LoVE4MUM mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesMalaysia
- Study dates
- 22 Apr 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- mothers with EPDS score 9-<12
- mothers with access to smartphone and internet connectivity
- continue routine postpartum care at the government health facilities
- literate in english and malay
Who cannot join
- history of drug abuse
- diagnosis of depressive illness or any other mental health illness
- undergoing treatment for mental health
- infant born with intrauterine death or died immediately after birth
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Hospital Tengku Ampuan Rahimah
Klang, Selangor, 41586
Noor Fadzleeyanna Mohd Yahaya, MOG, 03-3375 7000
Noor Fadzleeyanna Mohd Yahaya, MOG
Hospital Shah Alam
Shah Alam, Selangor, 40000
Siti Sabrina Kamarudin, 0355263000 ext. 3305, saby721@gmail.com
Siti Sabrina Kamarudin, MBBS
About this study
Official title: Leveraging on Virtual Engagement for Maternal Understanding & Mood-enhancement "LoVE4MUM" Mobile Application- A Protocol for Pilot Randomized Control Trial for Preventing Postpartum Depression
Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions.
Read the detailed description
Postpartum depression (PPD) is a significant mental health issue. Traditional support systems remains challenging and mHealth intervention provides an opportunity to access for support.
The primary objective of this study is to preliminarily assess the effectiveness of a developed mobile application called LoVE4MUM in prevention of postpartum depression. The study will employ a single-blinded, pilot randomized controlled trial (RCT) design involving a sample of 64 mothers. Participants will be randomly assigned in a 1:1 ratio to one of two groups: the intervention group, which will receive standard postpartum care plus LoVE4MUM mobile application, or the control group, which will receive standard postpartum care alone. The primary outcome measure will be the effectiveness of the mobile application in improving symptoms of postpartum depression among mothers. Secondary outcome measures will include changes in postpartum mental health literacy scores and negative automatic thoughts frequencies.
Through the systematic evaluation of the LoVE4MUM mobile application in conjunction with standard postpartum care, this pilot RCT aims to generate preliminary evidence regarding the efficacy and feasibility of using mHealth tools for preventing postpartum depression.
- Being tested
- LoVE4MUM mobile application
- Keywords
- Postpartum Depression, mHealth intervention, self-guided, postpartum mental health literacy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoVE4MUM mobile applicationDevice
LoVE4MUM is an innovative mobile application developed based on cognitive behavioral therapy and psychoeducation. The mobile application consist of 5 main modules which delivers information pertaining self-care, postpartum depression, handling negative thoughts, mood tracking and information for seeking help. The module consist of short notes, videos and worksheets for the participants to conduct.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | Mothers receiving treatment as usual (TAU) at the postpartum health care facilities according to standard guideline from period of delivery up to 6 weeks postpartum |
| Treatment as Usual & LoVE4MUM phone application | Experimental | Mothers receiving treatment as usual (TAU) and LoVE4MUM phone application from period of delivery up to 6 weeks postpartum Receives: Device: LoVE4MUM mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Depression
Self report measure using the Edinburgh Postpartum Depression Scale (EPDS) by the subjects on their symptoms of emotional distress during pregnancy and the postnatal period. Scale has been validated in English and Malay language with a total of 10 items based on 4 point Likert scale (0-3). Expected scoring 0 - 30. Score above 12 is considered probable depression.
Measured: Baseline, 1 week and 6 weeks postpartum
Secondary outcomes (2)
Postpartum Mental Health Literacy
self report measure using the Postpartum Depression Literacy Scale (PoDLiS) by the subjects on their knowledge and attitude on postpartum depression, help seeking, symptoms and available support. It has been validated in English and the Malay language. The 31 items is rated on a 5 point Likert scale (1-5). Total score is the total raw score divided by the total item. Higher score equivalents to higher postpartum mental health literacy
Measured: Baseline, 1 week and 6 weeks postpartum
Automatic Negative Frequency
self report measure using the Automatic Thoughts Questionnaire (ATQ) by the subjects on the frequency of experiencing the negative thought statement. It has been validated in the English and Malay language. The 17 items is rated based on a 5 point Likert scale (1-5). Total score 17- 85. Higher score equivalent to higher frequency of negative thoughts.
Measured: Baseline, 1 week and 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start22 Apr 2024 (estimated)
- Primary completion3 Jun 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blinded, Pilot Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health, Ministry of Health Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siti Sabrina binti Kamarudin, National Institutes of Health, Ministry of Health Malaysia
- Investigators
- Siti Sabrina Kamarudin, MBBS, Principal investigator, National Institute for Health, NIH Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366035
- Sponsor's protocol ID
- NMRR ID-24-00924-HPO
- Acronym
- LoVE4MUM
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: information could be available upon reaching out to the principal investigator. However date relative to the time when summary data are published or otherwise made available starting 6 months after publication.
Publications
Kamarudin SS, Idris IB, Sharip S, Ahmad N. LoVE4MUM Mobile App to Prevent Postpartum Depression: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 27;14:e63564. doi: 10.2196/63564.
PubMed 39869891
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging on Virtual Engagement for Maternal Understanding & Mood-enhancement "LoVE4MUM" Mobile Application- A Protocol for Pilot Randomized Control Trial for Preventing Postpartum Depression
- ClinicalTrials.gov ID
- NCT06366035
- Acronym / sponsor ID
- LoVE4MUM / NMRR ID-24-00924-HPO
- Keywords
- Postpartum Depression, mHealth intervention, self-guided, postpartum mental health literacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National Institutes of Health, Ministry of Health MalaysiaUniversity, hospital or other
- Study start
- 22 Apr 2024 (estimated)
- Primary completion
- 3 Jun 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 15 Apr 2024 (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.
Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions.
Detailed description
Postpartum depression (PPD) is a significant mental health issue. Traditional support systems remains challenging and mHealth intervention provides an opportunity to access for support.
The primary objective of this study is to preliminarily assess the effectiveness of a developed mobile application called LoVE4MUM in prevention of postpartum depression. The study will employ a single-blinded, pilot randomized controlled trial (RCT) design involving a sample of 64 mothers. Participants will be randomly assigned in a 1:1 ratio to one of two groups: the intervention group, which will receive standard postpartum care plus LoVE4MUM mobile application, or the control group, which will receive standard postpartum care alone. The primary outcome measure will be the effectiveness of the mobile application in improving symptoms of postpartum depression among mothers. Secondary outcome measures will include changes in postpartum mental health literacy scores and negative automatic thoughts frequencies.
Through the systematic evaluation of the LoVE4MUM mobile application in conjunction with standard postpartum care, this pilot RCT aims to generate preliminary evidence regarding the efficacy and feasibility of using mHealth tools for preventing postpartum depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Single Blinded, Pilot Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | –Mothers receiving treatment as usual (TAU) at the postpartum health care facilities according to standard guideline from period of delivery up to 6 weeks postpartum |
| Treatment as Usual & LoVE4MUM phone application | Experimental | Device: LoVE4MUM mobile applicationMothers receiving treatment as usual (TAU) and LoVE4MUM phone application from period of delivery up to 6 weeks postpartum |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- mothers with EPDS score 9-<12
- mothers with access to smartphone and internet connectivity
- continue routine postpartum care at the government health facilities
- literate in english and malay
Key exclusion criteria (4 listed)
- history of drug abuse
- diagnosis of depressive illness or any other mental health illness
- undergoing treatment for mental health
- infant born with intrauterine death or died immediately after birth
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 |
|---|---|---|
| LoVE4MUM mobile applicationLoVE4MUM is an innovative mobile application developed based on cognitive behavioral therapy and psychoeducation. The mobile application consist of 5 main modules which delivers information pertaining self-care, postpartum depression, handling negative thoughts, mood tracking and information for seeking help. The module consist of short notes, videos and worksheets for the participants to conduct. | Device | Treatment as Usual & LoVE4MUM phone application |
Primary outcome
Postpartum Depression
Time frame: Baseline, 1 week and 6 weeks postpartum
Self report measure using the Edinburgh Postpartum Depression Scale (EPDS) by the subjects on their symptoms of emotional distress during pregnancy and the postnatal period. Scale has been validated in English and Malay language with a total of 10 items based on 4 point Likert scale (0-3). Expected scoring 0 - 30. Score above 12 is considered probable depression.
2 secondary outcomes
Postpartum Mental Health Literacy
Time frame: Baseline, 1 week and 6 weeks postpartum
Automatic Negative Frequency
Time frame: Baseline, 1 week and 6 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 39869891Kamarudin SS, Idris IB, Sharip S, Ahmad N. LoVE4MUM Mobile App to Prevent Postpartum Depression: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 27;14:e63564. doi: 10.2196/63564.
- Individual participant dataSharing planned: No. information could be available upon reaching out to the principal investigator. However date relative to the time when summary data are published or otherwise made available starting 6 months after publication.
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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.
Siti Sabrina Kamarudin, MBBS principal investigator
National Institute for Health, NIH Malaysia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoVE4MUM mobile application in people with Postpartum Depression and Maternal Behavior, run by National Institutes of Health, Ministry of Health Malaysia at 2 sites in Malaysia.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siti Sabrina Kamarudin, MBBS (0355263000, saby721@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Depression (time frame: Baseline, 1 week and 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06366035, which also lists 1 linked publication.
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 16 Apr 2024.