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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postpartum Depression (PPD)
• Intervention / Treatment: Behavioral: positive psychology-based intervention package

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 Type: Interventional
• Enrollment (Estimated): 1438
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Community Primary Health Care Institutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants in the intervention group will receive a positive psychology-based primary care intervention package for postpartum depression.	Behavioral: positive psychology-based intervention package; 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
No Intervention: Control group; Participants in the control group will receive usual primary care support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the proportion of participants with postpartum depression	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline up to 3 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics Information	Information about the demographics of the participants	Baseline

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Behavioral Symptoms; Mood Disorders; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: HuazhongU20241201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No