Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat/WhatsApp on Dyadic Psychological and Sleep Outcomes
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: Couple-based psycho-socio-educational intervention using WeChat/WhatsApp.
- 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
- Center list to be confirmed — check the primary protocol.
- 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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Official title
Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat/WhatsApp on Dyadic Psychological and Sleep Outcomes: A 3-armed Randomised Controlled Trial
Overview
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.
Detailed description
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).
Interventions
- Behavioral 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
Primary outcome measures
- Psychological distress for perinatal women (objective and subjective) [Time frame: 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).]
Secondary outcome measures (3)
- Psychological distress for partners (objective and subjective) [Time frame: 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) [Time frame: 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) [Time frame: 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).]
Eligibility criteria
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
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
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07736378 · HMRF Ref: 23241531