Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat/WhatsApp on Dyadic Psychological and Sleep Outcomes

Официальное название

Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat/WhatsApp on Dyadic Psychological and Sleep Outcomes: A 3-armed Randomised Controlled Trial

Обзор

Background: Pregnancy is a challenging time, and couples frequently experience psychological and sleep problems. Despite the dyadic effects of these problems, most interventions have focused on pregnant women alone, not on couples. The research team developed an innovative intervention targeting couples during pregnancy to fill the research gaps. Objectives: (1) examine the effects of couple-based psycho-socio-educational intervention using WeChat/WhatsApp (WeLove) on dyadic psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction with wearable data (stress, heart rate, and sleep quality) immediately after the intervention, with follow-up assessments at 3 months and 12 months after the intervention; and (2) examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners. Methods: WeLove is a 6-week online intervention through WeChat/WhatsApp based on theoretical and evidence-based support. A three-arm double-blind randomized controlled trial will be used among 336 couples. Participants will be assigned to one of three groups and 112 couples per group: intervention 1 (couples for WeLove), intervention 2 (pregnant women for WeLove), or the control group (use WeChat/WhatsApp as normal). Participants will be assessed pre- and post-intervention, with follow-up assessments at 3 months and 12 months after the intervention. Generalized estimating equation analysis and thematic analysis will be performed to examine the research objectives. Potential contributions: The findings will provide a cost-effective way to improve psychological and sleep outcomes in couples. Policymakers can use the study's results as evidence to consider an innovative intervention that aims to improve antenatal services in Hong Kong.

Подробное описание

A prospective randomized 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 Couple-based psycho-socio-educational intervention using WeChat/WhatsApp
  There are 6-week sessions. Each session has (1) two short videos, (2) quizzes, (3) homework, (4) Q\&A sessions, and (5) professional support and additional resources accessible via navigable weblinks. Every session will focus on a certain topic and offer specialized advice. The participants will receive biweekly professional support through video conferencing to consolidate the content and address homework. Each session takes 15 to 20 minutes to finish. In addition, the research team will approa

Первичные конечные точки

• Psychological distress for perinatal women (objective and subjective) [Срок оценки: Baseline (Time [T] 0: >12-28 weeks of gestation), immediately after intervention (T1: >18-34 weeks of gestation), follow-up (T2: 3 months after intervention), and follow-up 2 (T3: 12 months after intervention).]

Вторичные конечные точки (3)

• Psychological distress for partners (objective and subjective) [Срок оценки: Baseline (Time [T] 0: >12-28 weeks of gestation), immediately after intervention (T1: >18-34 weeks of gestation), follow-up (T2: 3 months after intervention), and follow-up 2 (T3: 12 months after intervention).]
• Sleep outcomes for perinatal women and partners (objective and subjective) [Срок оценки: Baseline (Time [T] 0: >12-28 weeks of gestation), immediately after intervention (T1: >18-34 weeks of gestation), follow-up (T2: 3 months after intervention), and follow-up 2 (T3: 12 months after intervention).]
• Mental well-being in perinatal women and partners (subjective) [Срок оценки: Baseline (Time [T] 0: >12-28 weeks of gestation), immediately after intervention (T1: >18-34 weeks of gestation), follow-up (T2: 3 months after intervention), and follow-up 2 (T3: 12 months after intervention).]

Критерии участия

Inclusion:

• pregnant women over the age of 18
• pregnant women's partners over the age of 18
• women with a gestation of 12 to 28 weeks
• women and their partners can read and understand Chinese
• women and their partners possess electronic devices equipped with WhatsApp or WeChat
• women and their partners can provide written informed consent.

Exclusion:

• pregnant women and/or partners with current severe medical illnesses
• women and/or their partners with psychological problems
• women and/or their partners with 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

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07736378 · HMRF Ref: 23241531

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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