WhatsApp-based Psycho-socio-educational Intervention (WeLove) for Prevention of Psychological and Sleep Problems in Pregnant Women and Their Partners: A Three-arm Double-blinded Pilot Randomised Controlled Trial

Обзор

Objectives: (1) evaluate the feasibility and acceptability of the WhatsApp-based psycho-socio-educational intervention (WeLove); (2) preliminarily examine the effects of the intervention on psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction; and (3) preliminarily examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners. Methods: The investigators will use WhatsApp to provide the six sessions of the intervention, which include psychological, social, and educational components. A three-arm double-blinded pilot randomised controlled trial (RCT) is used in 60 couples, followed by individual face-to-face interviews for process evaluation in 10 to 20 couples based on data saturation. Participants will be assigned to one of three groups and 20 couples per group: intervention 1 (couples for WeLove), intervention 2 (pregnant women for WeLove), or the control group (use WhatsApp as normal). Participants will be assessed pre- and post-intervention. Generalised estimating equation analysis and thematic analysis will be performed to examine the research objectives.

Подробное описание

Study design A prospective randomised double-blind, three-arm, parallel-group design will be adopted. The report of the trial will follow the Consolidated Standards of Reporting Trials guidelines for an Internet-based intervention (CONSORT-EHEALTH).

Вмешательства

• Поведенческое WhatsApp as usual
  Pregnant women and their partners are instructed to use WhatsApp as normal for six weeks.
• Поведенческое WhatsApp-based psycho-socio-educational intervention (WeLove)
  The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation. Each session has two short videos, quizzes, forums, and homework. The content is presented through a virtual midwife using storytelling of real-life scenarios, animation, and case vignettes about psychological and sleep problems during pregnancy. A virtual midwife acts as an educator to explain the prevalence, causes, an

Первичные конечные точки

• Psychological outcome: Depression, anxiety and stress symptoms [Срок оценки: Baseline, pre-intervention and immediately after the intervention]

Вторичные конечные точки (2)

• Sleep outcomes: Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction [Срок оценки: Baseline, pre-intervention and immediately after the intervention]
• Psychological well-being: Subjective well-being [Срок оценки: Baseline, pre-intervention and immediately after the intervention]

Критерии участия

Критерии включения

• pregnant with a gestation of >12 to 28 weeks and their partners over 18 years
• able to read and understand Chinese
• have electronic devices with WhatsApp that can contact the Internet
• can provide written consent and voluntary participation in this study

Критерии исключения

• current severe medical illnesses
• psychological and sleep disorders

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Гонконг · 1 центр

• The Chinese University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT06768190 · RS-2023-LY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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