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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WhatsApp as usual, WhatsApp-based psycho-socio-educational intervention (WeLove).
- Who it may be relevant to
- Registry conditions: Sleep Problems, Psychological, Well-Being, Psychological. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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).
Interventions
- Behavioral WhatsApp as usual
Pregnant women and their partners are instructed to use WhatsApp as normal for six weeks. - Behavioral 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
Primary outcome measures
- Psychological outcome: Depression, anxiety and stress symptoms [Time frame: Baseline, pre-intervention and immediately after the intervention]
Secondary outcome measures (2)
- Sleep outcomes: Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction [Time frame: Baseline, pre-intervention and immediately after the intervention]
- Psychological well-being: Subjective well-being [Time frame: Baseline, pre-intervention and immediately after the intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- current severe medical illnesses
- psychological and sleep disorders
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Hong Kong · 1 center
- The Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT06768190 · RS-2023-LY