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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Psychological outcome: Depression, anxiety and stress symptoms
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The randomization of participants will enable the enrolling researcher to remain blind to participant conditions throughout the trial. The research assistants evaluating the participants are blinded to the group assignment. The assistants analysing participant data are also blinded to the group assignment. The active nature of the control condition may also allow us to blind the participants to the condition. The participants will be informed that the study aims to investigate the efficacy of three conditions to improve psychological and sleep well-being. However, they will not be explicitly advised of the content or intention. This minor deception is designed to yield a double-blind trial of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •current severe medical illnesses
- •psychological and sleep disorders
结局指标
主要结局
Psychological outcome: Depression, anxiety and stress symptoms
时间窗: Baseline, pre-intervention and immediately after the intervention
Depression, anxiety and stress symptoms will be assessed by the Chinese version of 21-item Depression Anxiety and Stress Scale (DASS-21). It has three subscales with seven items each: stress, anxiety, and depressive symptoms. Four-point rating scales, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), are used to categorise frequency and severity. The final scores are obtained by multiplying each subscale's values by two. Every subscale has a total score that varies from 0 to 42; a high score on any subscale denotes a higher level of stress, anxiety, and depressive symptoms
次要结局
- Sleep outcomes: Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction(Baseline, pre-intervention and immediately after the intervention)
- Psychological well-being: Subjective well-being(Baseline, pre-intervention and immediately after the intervention)
研究者
Lau Ying
Professor
Chinese University of Hong Kong