EMA and mHealth in Preventing Postpartum Depression

NCT06777563 | Recruiting DMC

• 1 other identifier: PPD prevention
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This proposed study aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model that combines brief psychological counselling, Ecological Momentary Assessment (EMA), mHealth-based psychological support, and CBT-guided telephone counselling to prevent postpartum depression (PPD).

Conditions

Postpartum Depression (PPD); Ecological Momentary Assessment; mHealth Intervention

Keywords

postpartum depression; ecological momentary assessment; mHealth-based intervention; pregnant women

Outcome Measures

Primary Outcomes (1)

• Postpartum depression

  Postpartum depression will be measured by Edinburgh Postnatal Depression Scale (EPDS-10). The score ranges from 0-30. 0-9 indicates minimal or no depressive symptoms.10-12 suggests mild depressive symptoms and further monitoring may be recommended.13-14 indicates moderate depressive symptoms and a potential need for further assessment.15-30 suggests significant depressive symptoms and likely clinical depression, requiring further evaluation and intervention.

  2-week postpartum

Secondary Outcomes (4)

• Postpartum depression

  4, 6, 8 weeks postpartum

• Anxiety

  2, 4, 6, 8 weeks postpartum

• Depression

  2, 4, 6, 8 weeks postpartum

• Stress

  2, 4, 6, 8 weeks postpartum

Study Arms (3)

Intervention group (EMA + IM)

EXPERIMENTAL

The EMA+IM group (group A) will receive an evidence-based intervention composed of brief psychological counselling and health education, 2-week EMA, 10-week mHealth-based psychological support, and CBT-guided telephone counselling, guided by comprehensive assessment.

Behavioral: Brief psychological counselling and health education; Behavioral: 2 Weeks of Ecological Momentary Assessment (EMA); Behavioral: 10 weeks of mobile health psychological support; Behavioral: CBT-guided telephone counselling booster

EMA group

EXPERIMENTAL

The EMA group (Group B) will receive brief psychological counselling and health education and 2-week EMA.

Behavioral: Brief psychological counselling and health education; Behavioral: 2 Weeks of Ecological Momentary Assessment (EMA)

Control group

ACTIVE COMPARATOR

The control group (group C) will receive only brief psychological counselling and health education.

Behavioral: Brief psychological counselling and health education

Interventions

Brief psychological counselling and health education BEHAVIORAL

This is a brief 1-on-1 psychological counselling, including potential mood fluctuation during pregnancy, possible prepartum depressive symptoms, and available psychiatric consultation and medication in Hong Kong with self-help psychoeducational materials.

Control group; EMA group; Intervention group (EMA + IM)

2 Weeks of Ecological Momentary Assessment (EMA) BEHAVIORAL

The 2-week EMA period will start the next day. Participants will be prompted to answer questions about emotion (e.g. worry, enjoyment, anxiety, etc.) and other lifestyle and environmental triggers through the smartphone notification function. There will be a 2-hour window for each assessment before expiration and total 5 assessments a day.

EMA group; Intervention group (EMA + IM)

10 weeks of mobile health psychological support BEHAVIORAL

A total of 20 regular instant messages (e.g., via WhatsApp) personalised by baseline demographic characteristics (current pregnancy details, history of postpartum mental illness) and results of EMA will be sent to the participants in multi-media formats.

Intervention group (EMA + IM)

CBT-guided telephone counselling booster BEHAVIORAL

A 45-minute telephone counselling based on CBT.

Intervention group (EMA + IM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women who are in their 20 to 28 weeks of gestation,
• Receiving regular antenatal care service in Hong Kong,
• Had a total score ≥7 in EPDS-10 (suggesting potential distress symptoms),
• Able to read and understand Chinese and use an instant messaging app weekly

You may not qualify if:

• \) Pregnant women who are undergoing psychiatric/psychological treatment.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

School of Nursing, The University of Hong Kong

Hong Kong, Pokfulam, 999077, Hong Kong

RECRUITING

The Queen Mary Hospital

Hong Kong, Pokfulam, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Shengzhi Zhao, PhD

CONTACT

+852 6561 4500; lubabezz@connect.hku.hk

Mengyao Li, Mphil

CONTACT

+852 6851 8462; lmy0814@connect.hku.hk

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: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 16, 2025
• Study Start: August 25, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)