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NCT Number: NCT06770244

Positive Psychology-Based Intervention Program for Postpartum Depression Within Primary Healthcare System

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Community Primary Health Care Institutions

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years;
  • women in the early stages of pregnancy;
  • adequate cognitive, comprehension, and communication abilities, and voluntary participation in the study.

Exclusion criteria

  • individuals with severe organic or somatic diseases;
  • those with a history of mental illness, substance abuse, or a family history of psychiatric disorders.

Treatment and study plan

positive psychology-based intervention package

Behavioral

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.

Other names: Holistic Well-being Intervention Framework

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in postnatal depression scale score

    Time frame: Baseline up to 3 months postpartum

    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.

  2. Anxiety Symptoms Assessment

    Time frame: Baseline up to 3 months postpartum

    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.

  3. Stress Assessment

    Time frame: Baseline up to 3 months postpartum

    The Perceived Stress Scale (PSS) primarily measures individuals' subjective perception of stress over the past month in daily life.

Other outcomes

  1. Demographics Information

    Time frame: Baseline

    Information about the demographics of the participants

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

Positive Psychology-Based Intervention Program for Postpartum Depression Within Primary Healthcare System: Protocol for a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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