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

NCT06770244 | Enrolling By Invitation DMC

• 1 other identifier: HuazhongU20241201
• Study Type: interventional
• Target: 1,438
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depression (PPD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in postnatal depression scale score

  Baseline up to 3 months postpartum

• Anxiety Symptoms Assessment

  Baseline up to 3 months postpartum

• Stress Assessment

  Baseline up to 3 months postpartum

Other Outcomes (1)

• Demographics Information

  Baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group will receive a positive psychology-based primary care intervention package for postpartum depression.

Behavioral: positive psychology-based intervention package

Control group

NO INTERVENTION

Participants in the control group will receive usual primary care support.

Interventions

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.

Also known as: Holistic Well-being Intervention Framework

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Community Primary Health Care Institutions

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• 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.

  PMID: 40780718 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Social Medicne and Health Management Department

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)