Postpartum Depression (PPD)NCT06770244
Positive Psychology-Based Intervention Program for Postpartum Depression Within Primary Healthcare System
A study testing positive psychology-based intervention package in people with Postpartum Depression (PPD), run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study is a prospective, two-arm parallel cluster randomized controlled trial that will compare the intervention effects of a positive psychology-based intervention package with usual care for postpartum depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression (PPD)
- What is being tested?
- positive psychology-based intervention package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,438 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 31 Oct 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years;
- women in the early stages of pregnancy;
- adequate cognitive, comprehension, and communication abilities, and voluntary participation in the study.
Who cannot join
- individuals with severe organic or somatic diseases;
- those with a history of mental illness, substance abuse, or a family history of psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Positive Psychology-Based Intervention Program for Postpartum Depression Within Primary Healthcare System: Protocol for a Randomized Controlled Trial
This study is a prospective, two-arm parallel cluster randomized controlled trial that will compare the intervention effects of a positive psychology-based intervention package with usual care for postpartum depression.
Read the detailed description
Postpartum depression is one of the most common conditions affecting women during the perinatal period. It has a profound negative impact on both women's physical and mental health, manifesting in symptoms such as persistent low mood, sleep disturbances, changes in appetite, and a diminished sense of self-worth. In more severe cases, it may even lead to suicidal ideation or self-harm. Furthermore, postpartum depression significantly impairs a mother's caregiving ability, weakening the emotional bond between mother and infant. This disruption in the mother-infant relationship, in turn, can negatively affect the infant's social, emotional, and cognitive development.
Positive Psychology is an emerging subfield of psychology that focuses on the study of human positive emotions, well-being, and optimal adaptation. In contrast to traditional psychology, which primarily addresses mental illness, abnormal behaviors, and negative emotions, Positive Psychology seeks to explore and enhance the ways in which individuals and groups can thrive in areas such as positive emotions, health, and happiness. By focusing on strengths, resilience, and positive interpersonal relationships, Positive Psychology aims to foster well-being rather than merely alleviating psychological distress.
The emphasis on prevention in Positive Psychology aligns closely with the core principles of community-based primary healthcare, which prioritizes early intervention, education, and the promotion of wellness within a population. By focusing on proactive strategies that enhance mental health, Positive Psychology contributes to a broader public health agenda aimed at reducing the burden of mental disorders through early prevention rather than relying solely on treatment after the onset of illness. Therefore, integrating Positive Psychology into primary healthcare settings-particularly in the prevention and management of postpartum depression in women-offers substantial potential benefits.
This study will design a community-based intervention program for postpartum depression, centered on Positive Psychology, within the framework of the primary healthcare system. The program will be developed based on the developmental characteristics and practical needs of women experiencing postpartum depression. A cluster-randomized controlled trial will be employed to evaluate the effectiveness of the intervention. The findings will provide valuable evidence and support for mental health management measures for pregnant and postpartum women in primary healthcare settings, thereby promoting the effective implementation of maternal and child health initiatives.
- Conditions
- Postpartum Depression (PPD)
- Being tested
- positive psychology-based intervention package
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive psychology-based intervention packageBehavioural
Also called Holistic Well-being Intervention Framework
The postpartum depression intervention program will be developed in accordance with the principles of positive psychology, incorporating online psychological interventions as the primary mode of delivery. Specifically, psychological courses and training based on positive psychology will be conducted in addition to the usual community-based primary health care. Interventions use formats that include online videos and supplemental materials. The aim of the intervention is to help pregnant and postpartum women understand mental health, enhance positive emotions, improve negative emotions, maintain interpersonal relationships, and explore life meaning. Additionally, one-on-one online consultations based on positive psychology will be offered to high-risk women.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will receive a positive psychology-based primary care intervention package for postpartum depression. Receives: Behavioral: positive psychology-based intervention package |
| Control group | No intervention | Participants in the control group will receive usual primary care support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of participants with postpartum depression
Measured: baseline (early pregnancy, T0), during the intervention (3 months post-randomization, T1; 6 months post-randomization, T2), and after the intervention (1 month postpartum, T3; 3 months postpartum, T4).
Secondary outcomes (3)
Change in postnatal depression scale score
EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed.
Measured: Baseline up to 3 months postpartum
Anxiety Symptoms Assessment
The Generalized Anxiety Disorder 7 (GAD-7) scale is a commonly used tool for screening generalized anxiety disorder, designed to assess the severity of anxiety symptoms in participants.
Measured: Baseline up to 3 months postpartum
Stress Assessment
The Perceived Stress Scale (PSS) primarily measures individuals' subjective perception of stress over the past month in daily life.
Measured: Baseline up to 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 posted13 Jan 2025
- Study start1 Feb 2025
- Primary completion1 May 2026 (estimated)
- Study completion31 Oct 2026 (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 Depression (PPD)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Gong, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770244
- Sponsor's protocol ID
- HuazhongU20241201
- Status last verified
- Feb 2025
- First submitted
- 6 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fan Z, Weng M, Su J, Yu R, Wang J, Yin X, Xia W, Gong Y. Positive psychology-based intervention programme for postpartum depression among pregnant women within the primary healthcare system: protocol for a randomised controlled trial. BMJ Open. 2025 Aug 8;15(8):e101115. doi: 10.1136/bmjopen-2025-101115.
PubMed 40780718
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Psychology-Based Intervention Program for Postpartum Depression Within Primary Healthcare System: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06770244
- Acronym / sponsor ID
- HuazhongU20241201
- Conditions
- Postpartum Depression (PPD)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,438 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Jan 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.
This study is a prospective, two-arm parallel cluster randomized controlled trial that will compare the intervention effects of a positive psychology-based intervention package with usual care for postpartum depression.
Detailed description
Postpartum depression is one of the most common conditions affecting women during the perinatal period. It has a profound negative impact on both women's physical and mental health, manifesting in symptoms such as persistent low mood, sleep disturbances, changes in appetite, and a diminished sense of self-worth. In more severe cases, it may even lead to suicidal ideation or self-harm. Furthermore, postpartum depression significantly impairs a mother's caregiving ability, weakening the emotional bond between mother and infant. This disruption in the mother-infant relationship, in turn, can negatively affect the infant's social, emotional, and cognitive development.
Positive Psychology is an emerging subfield of psychology that focuses on the study of human positive emotions, well-being, and optimal adaptation. In contrast to traditional psychology, which primarily addresses mental illness, abnormal behaviors, and negative emotions, Positive Psychology seeks to explore and enhance the ways in which individuals and groups can thrive in areas such as positive emotions, health, and happiness. By focusing on strengths, resilience, and positive interpersonal relationships, Positive Psychology aims to foster well-being rather than merely alleviating psychological distress.
The emphasis on prevention in Positive Psychology aligns closely with the core principles of community-based primary healthcare, which prioritizes early intervention, education, and the promotion of wellness within a population. By focusing on proactive strategies that enhance mental health, Positive Psychology contributes to a broader public health agenda aimed at reducing the burden of mental disorders through early prevention rather than relying solely on treatment after the onset of illness. Therefore, integrating Positive Psychology into primary healthcare settings-particularly in the prevention and management of postpartum depression in women-offers substantial potential benefits.
This study will design a community-based intervention program for postpartum depression, centered on Positive Psychology, within the framework of the primary healthcare system. The program will be developed based on the developmental characteristics and practical needs of women experiencing postpartum depression. A cluster-randomized controlled trial will be employed to evaluate the effectiveness of the intervention. The findings will provide valuable evidence and support for mental health management measures for pregnant and postpartum women in primary healthcare settings, thereby promoting the effective implementation of maternal and child health initiatives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: positive psychology-based intervention packageParticipants in the intervention group will receive a positive psychology-based primary care intervention package for postpartum depression. |
| Control group | No intervention | –Participants in the control group will receive usual primary care support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years;
- women in the early stages of pregnancy;
- adequate cognitive, comprehension, and communication abilities, and voluntary participation in the study.
Key exclusion criteria (2 listed)
- individuals with severe organic or somatic diseases;
- those with a history of mental illness, substance abuse, or a family history of psychiatric disorders.
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 |
|---|---|---|
| positive psychology-based intervention packageAlso: Holistic Well-being Intervention FrameworkThe postpartum depression intervention program will be developed in accordance with the principles of positive psychology, incorporating online psychological interventions as the primary mode of delivery. Specifically, psychological courses and training based on positive psychology will be conducted in addition to the usual community-based primary health care. Interventions use formats that include online videos and supplemental materials. The aim of the intervention is to help pregnant and postpartum women understand mental health, enhance positive emotions, improve negative emotions, maintain interpersonal relationships, and explore life meaning. Additionally, one-on-one online consultations based on positive psychology will be offered to high-risk women. | Behavioural | Intervention group |
Primary outcome
the proportion of participants with postpartum depression
Time frame: baseline (early pregnancy, T0), during the intervention (3 months post-randomization, T1; 6 months post-randomization, T2), and after the intervention (1 month postpartum, T3; 3 months postpartum, T4).
3 secondary outcomes
Change in postnatal depression scale score
Time frame: Baseline up to 3 months postpartum
Anxiety Symptoms Assessment
Time frame: Baseline up to 3 months postpartum
Stress Assessment
Time frame: Baseline up to 3 months postpartum
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 21 Feb 2025.
- Derived from this study: PubMed 40780718Fan Z, Weng M, Su J, Yu R, Wang J, Yin X, Xia W, Gong Y. Positive psychology-based intervention programme for postpartum depression among pregnant women within the primary healthcare system: protocol for a randomised controlled trial. BMJ Open. 2025 Aug 8;15(8):e101115. doi: 10.1136/bmjopen-2025-101115.
- Individual participant dataSharing planned: No
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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.
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 positive psychology-based intervention package in people with Postpartum Depression (PPD), run by Huazhong University of Science and Technology at 1 site in China.
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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 21 Feb 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 China. 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 proportion of participants with postpartum depression (time frame: baseline (early pregnancy, T0), during the intervention (3 months post-randomization, T1; 6 months post-randomization, T2), and after the intervention (1 month postpartum, T3; 3 months postpartum, T4).). 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 NCT06770244, 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 21 Feb 2025.