EMA and mHealth in Preventing Postpartum Depression

Официальное название

Ecological Momentary Assessment Combined mHealth-based Psychosocial Intervention to Prevent Postpartum Depression in Pregnant Women: a Pilot Randomized Controlled Trial

Обзор

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).

Подробное описание

The target participants are pregnant women between 20 and 28 weeks of gestation with a total EPDS-10 score of ≥7. Sixty participants will be actively recruited from the Department of Obstetrics and Gynaecology at Queen Mary Hospital (QMH), a major acute hospital in Hong Kong. Recruitment will extend to other public hospitals if needed.

This study will be a three-arm (allocation ratio:1:1:1; permutated block size of 3, 6, and 9), single-blinded, parallel, pilot randomised controlled trial (RCT) with follow-ups at 2, 4, 6, and 8 weeks post-enrollment using standard methodology (CONSORT) to evaluate the effectiveness of the intervention. The EMA+IM group (group A) will receive an evidence-based intervention composed of brief psychological counselling and health education, 2-week EMA, mHealth-based psychological support, and CBT-guided telephone counselling, guided by comprehensive assessment. The EMA group (Group B) will only receive a 2-week EMA, and the control group (group C) will receive only brief psychological counselling and health education. Surveys will be collected via telephone after childbirth. Semi-structured individual interviews will be conducted with the participants in the intervention group to understand the experience and the perceptions towards the EMA data collection and mHealth-based intervention on mental health.

The primary clinical outcome of this study will be the difference in the EPDS scores between the two groups at 2 weeks postpartum. Secondary clinical outcomes will include differences in anxiety levels, stress levels, and insomnia symptoms at 2, 4, 6 and 8 weeks postpartum. Differences in participants' self-rated health, family functioning, family well-being and perceived happiness will also be analyzed.

Вмешательства

• Поведенческое Brief psychological counselling and health education
  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.
• Поведенческое 2 Weeks of Ecological Momentary Assessment (EMA)
  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.
• Поведенческое 10 weeks of mobile health psychological support
  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.
• Поведенческое CBT-guided telephone counselling booster
  A 45-minute telephone counselling based on CBT.

Первичные конечные точки

• Postpartum depression [Срок оценки: 2-week postpartum]

Вторичные конечные точки (4)

• Postpartum depression [Срок оценки: 4, 6, 8 weeks postpartum]
• Anxiety [Срок оценки: 2, 4, 6, 8 weeks postpartum]
• Depression [Срок оценки: 2, 4, 6, 8 weeks postpartum]
• Stress [Срок оценки: 2, 4, 6, 8 weeks postpartum]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Гонконг · 2 центра

• School of Nursing, The University of Hong Kong — Гонконг
• The Queen Mary Hospital — Гонконг

Идентификаторы

NCT: NCT06777563 · PPD prevention

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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