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

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Psychological; Sleep Problems; Well-Being, Psychological

Treatments: Behavioral: Couple-based psycho-socio-educational intervention using WeChat/WhatsApp

Study type: Interventional

Funder types: Other

Identifiers

NCT07736378

HMRF Ref: 23241531

Details and patient eligibility

About

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.

Full 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).

Enrollment: 336 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

336 participants in 3 patient groups

WeLove Intervention for Couples

Experimental group

Description:

Pregnant women and their partners will participate in a six-week WeLove intervention, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioral activation.

Treatment:

Behavioral: Couple-based psycho-socio-educational intervention using WeChat/WhatsApp

WeLove Intervention for Women Only

Experimental group

Description:

Only pregnant women will participate in a six-week WeLove intervention. All contents are the same as in intervention group 1.

Treatment:

Behavioral: Couple-based psycho-socio-educational intervention using WeChat/WhatsApp

Control group

No Intervention group

Description:

The investigators implemented standard care as the control group, which encompassed routine antenatal check-ups, screening and testing, ultrasound scans, health education, and monitoring of maternal and infant health.