Postnatal DepressionNCT06557200
A Virtual Support Intervention for Postnatal Well-being
A study testing Digital Infant- parents support in people with Postnatal Depression and Mother-Infant Interaction, run by Universiti Putra Malaysia at 1 site in Pakistan.
Trial summary
Postnatal depression (PND) and anxiety are significant public health concerns affecting a substantial proportion of new mothers worldwide. These conditions can have profound consequences for both maternal and infant well-being, including increased risk of 1. maternal morbidity 2. impaired parent-infant bonding 3. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postnatal Depression, Mother-Infant Interaction
- What is being tested?
- Digital Infant- parents support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2024to 10 Aug 2025
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pakistani female aged 18-45 years
- Recent childbirth (within 0-6 weeks)
- Access to a smartphone or computer with internet connectivity
- Able to understand and communicate in Urdu or English
- Willing to provide informed consent
Who cannot join
- Pre-existing severe mental illness (e.g., schizophrenia, bipolar disorder)
- Current substance abuse or dependence
- Limited or no access to the internet or smartphone
- Inability to understand or communicate in Urdu or English
- Pregnancy complications requiring intensive care
- Infants with severe medical conditions requiring hospitalization
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ahmad Hospital
Lahore, Punjab Province, 54590
MUHAMMAD ARSHED, MBBS, 03337474464, drarshedchaudhary@gmail.com
About this study
Official title: Empowering Early Parenthood: A Digital Psychoeducational Support Intervention for Postnatal Well-being
Postnatal depression (PND) and anxiety are significant public health concerns affecting a substantial proportion of new mothers worldwide. These conditions can have profound consequences for both maternal and infant well-being, including increased risk of
- maternal morbidity
- impaired parent-infant bonding
- long-term developmental challenges for the child.
Read the detailed description
Despite the prevalence and impact of PND and anxiety, access to timely and effective mental health care for postpartum women remains limited, particularly in resource-constrained settings.
Limited Research: There has been a historical underinvestment in mental health research in Pakistan, especially in maternal mental health.
Cultural Stigma: Mental health issues, particularly postpartum depression, are often stigmatized, leading to underreporting.
Data Infrastructure: Robust data collection and analysis systems for mental health are still developing in Pakistan The rationale for this study is grounded in the significant public health burden imposed by postnatal depression (PND) and anxiety, coupled with the limitations of traditional care models. Despite advancements in maternal and child health, postpartum mental health remains a neglected area in many countries, including Pakistan.
- Conditions
- Postnatal Depression, Mother-Infant Interaction
- Being tested
- Digital Infant- parents support
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Infant- parents supportBehavioural
A virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion. Receives: Behavioral: Digital Infant- parents support |
| Control | No intervention | No intervention will be provided except usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post natal depression
Edinburgh Postnatal Depression Scale (EPDS): A standardized self-report questionnaire to assess symptoms of postnatal depression. Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Scores of 13 indicate an 80% chance that the mother has depression.
Measured: Post natal Depression measured at baseline and 12 months
Post natal anxiety
Generalized Anxiety Disorder-7 (GAD-7): A self-report measure to assess symptoms of generalized anxiety disorder. The GAD-7 scores were also represented with clinical categorizations of anxiety levels as follows: GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe).
Measured: Post natal Anxiety measured at baseline and 12 months
Intervention usage
Intervention usage will be assessed by tracking participants' engagement with the online platform, including login frequency, module completion, and time spent on the platform.
Measured: Intervention usage measured at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postnatal 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557200
- Sponsor's protocol ID
- UIPT
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol, Statistical plan, Results will be desseminated through publications
Publications
Woody CA, Ferrari AJ, Siskind DJ, Whiteford HA, Harris MG. A systematic review and meta-regression of the prevalence and incidence of perinatal depression. J Affect Disord. 2017 Sep;219:86-92. doi: 10.1016/j.jad.2017.05.003. Epub 2017 May 8.
PubMed 28531848Hahn-Holbrook J, Cornwell-Hinrichs T, Anaya I. Economic and Health Predictors of National Postpartum Depression Prevalence: A Systematic Review, Meta-analysis, and Meta-Regression of 291 Studies from 56 Countries. Front Psychiatry. 2018 Feb 1;8:248. doi: 10.3389/fpsyt.2017.00248. eCollection 2017.
PubMed 29449816Coo S, Garcia MI, Mira A, Valdes V. The Role of Perinatal Anxiety and Depression in Breastfeeding Practices. Breastfeed Med. 2020 Aug;15(8):495-500. doi: 10.1089/bfm.2020.0091. Epub 2020 Jun 9.
PubMed 32522015Rojas G. Análisis de La Situación de Uso de Servicios y Acceso a Tratamiento de La Depresión Posparto En Centros APS de La Región Metropolitana. Santiago, Chile: Universidad de Chile, http://www.crececontigo.gob.cl/wp-content/uploads/2015/11/5-Informe-Final-Analisis-de-lasituacion-de-uso-de-servicio-y-acceso-a-tratamiento-de-la-depresion-posparto.pdf (2013, accessed 15 January 2022).
Priel A, Djalovski A, Zagoory-Sharon O, Feldman R. Maternal depression impacts child psychopathology across the first decade of life: Oxytocin and synchrony as markers of resilience. J Child Psychol Psychiatry. 2019 Jan;60(1):30-42. doi: 10.1111/jcpp.12880. Epub 2018 Feb 27.
PubMed 29484656
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Early Parenthood: A Digital Psychoeducational Support Intervention for Postnatal Well-being
- ClinicalTrials.gov ID
- NCT06557200
- Acronym / sponsor ID
- UIPT
- Conditions
- Postnatal Depression, Mother-Infant Interaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 16 Aug 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.
Postnatal depression (PND) and anxiety are significant public health concerns affecting a substantial proportion of new mothers worldwide. These conditions can have profound consequences for both maternal and infant well-being, including increased risk of
- maternal morbidity
- impaired parent-infant bonding
- long-term developmental challenges for the child.
Detailed description
Despite the prevalence and impact of PND and anxiety, access to timely and effective mental health care for postpartum women remains limited, particularly in resource-constrained settings.
Limited Research: There has been a historical underinvestment in mental health research in Pakistan, especially in maternal mental health.
Cultural Stigma: Mental health issues, particularly postpartum depression, are often stigmatized, leading to underreporting.
Data Infrastructure: Robust data collection and analysis systems for mental health are still developing in Pakistan The rationale for this study is grounded in the significant public health burden imposed by postnatal depression (PND) and anxiety, coupled with the limitations of traditional care models. Despite advancements in maternal and child health, postpartum mental health remains a neglected area in many countries, including Pakistan.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Digital Infant- parents supportA virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion. |
| Control | No intervention | –No intervention will be provided except usual care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pakistani female aged 18-45 years
- Recent childbirth (within 0-6 weeks)
- Access to a smartphone or computer with internet connectivity
- Able to understand and communicate in Urdu or English
- Willing to provide informed consent
Key exclusion criteria (6 listed)
- Pre-existing severe mental illness (e.g., schizophrenia, bipolar disorder)
- Current substance abuse or dependence
- Limited or no access to the internet or smartphone
- Inability to understand or communicate in Urdu or English
- Pregnancy complications requiring intensive care
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 |
|---|---|---|
| Digital Infant- parents supportA virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion. | Behavioural | Intervention group |
Primary outcome
Post natal depression
Time frame: Post natal Depression measured at baseline and 12 months
Edinburgh Postnatal Depression Scale (EPDS): A standardized self-report questionnaire to assess symptoms of postnatal depression. Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Scores of 13 indicate an 80% chance that the mother has depression.
Post natal anxiety
Time frame: Post natal Anxiety measured at baseline and 12 months
Generalized Anxiety Disorder-7 (GAD-7): A self-report measure to assess symptoms of generalized anxiety disorder. The GAD-7 scores were also represented with clinical categorizations of anxiety levels as follows: GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe).
Intervention usage
Time frame: Intervention usage measured at 12 months
Intervention usage will be assessed by tracking participants' engagement with the online platform, including login frequency, module completion, and time spent on the platform.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 28531848Woody CA, Ferrari AJ, Siskind DJ, Whiteford HA, Harris MG. A systematic review and meta-regression of the prevalence and incidence of perinatal depression. J Affect Disord. 2017 Sep;219:86-92. doi: 10.1016/j.jad.2017.05.003. Epub 2017 May 8.
- Background: PubMed 29449816Hahn-Holbrook J, Cornwell-Hinrichs T, Anaya I. Economic and Health Predictors of National Postpartum Depression Prevalence: A Systematic Review, Meta-analysis, and Meta-Regression of 291 Studies from 56 Countries. Front Psychiatry. 2018 Feb 1;8:248. doi: 10.3389/fpsyt.2017.00248. eCollection 2017.
- Background: PubMed 32522015Coo S, Garcia MI, Mira A, Valdes V. The Role of Perinatal Anxiety and Depression in Breastfeeding Practices. Breastfeed Med. 2020 Aug;15(8):495-500. doi: 10.1089/bfm.2020.0091. Epub 2020 Jun 9.
- BackgroundRojas G. Análisis de La Situación de Uso de Servicios y Acceso a Tratamiento de La Depresión Posparto En Centros APS de La Región Metropolitana. Santiago, Chile: Universidad de Chile, http://www.crececontigo.gob.cl/wp-content/uploads/2015/11/5-Informe-Final-Analisis-de-lasituacion-de-uso-de-servicio-y-acceso-a-tratamiento-de-la-depresion-posparto.pdf (2013, accessed 15 January 2022).
- Background: PubMed 29484656Priel A, Djalovski A, Zagoory-Sharon O, Feldman R. Maternal depression impacts child psychopathology across the first decade of life: Oxytocin and synchrony as markers of resilience. J Child Psychol Psychiatry. 2019 Jan;60(1):30-42. doi: 10.1111/jcpp.12880. Epub 2018 Feb 27.
- Individual participant dataSharing planned: No. Study protocol, Statistical plan, Results will be desseminated through publications
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Infant- parents support in people with Postnatal Depression and Mother-Infant Interaction, run by Universiti Putra Malaysia at 1 site in Pakistan.
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 5 inclusion and 6 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 Aug 2024. 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 Pakistan. 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 Raashed Muhammad, Master (03249479263, stunning003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post natal depression (time frame: Post natal Depression measured at baseline and 12 months). The study lists 3 primary outcomes in all. 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 NCT06557200, which also lists 5 linked publications.
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 Aug 2024.