Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07736378

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Sleep Problems Behavior Mental Disorders Nervous System Diseases Parasomnias Personal Satisfaction Psychological Psychological Well-Being Sleep Wake Disorders Well-Being, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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 approach each participant via WeChat or WhatsApp for consolidating their knowledge after sessions 2, 4, and 6. The duration of contact ranged from 10 to 15 minutes. Each participant can finish the session at a flexible pace.

Primary outcomes

  1. 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).

    Objective measures The investigators utilize a wearable wristband (Xiaomi Mi Smart Band) to objectively assess psychological distress in perinatal women. The psychological outcomes will include heart rate and stress level scores.

    Subjective measure The Chinese version of the 21-item Depression Anxiety Stress Scale is used to assess the severity of general psychological distress. It has three subscales with seven items each: stress, anxiety, and depressive symptoms. The scores of each subscale were multiplied by 2 to calculate the final score. The total score ranges from 0 to 42 for each subscale, with higher scores indicating more severe symptoms. The 21-item Depression Anxiety Stress Scale demonstrated satisfactory psychometric properties in Chinese populations.

Secondary outcomes

  1. 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).

    Objective measures The investigators utilize a wearable wristband (Xiaomi Mi Smart Band) to objectively assess psychological distress in perinatal women. The psychological outcomes will include heart rate and stress level scores.

    Subjective measure The Chinese version of the 21-item Depression Anxiety Stress Scale is used to assess the severity of general psychological distress. It has three subscales with seven items each: stress, anxiety, and depressive symptoms. The scores of each subscale were multiplied by 2 to calculate the final score. The total score ranges from 0 to 42 for each subscale, with higher scores indicating more severe symptoms. The 21-item Depression Anxiety Stress Scale demonstrated satisfactory psychometric properties in Chinese populations.

  2. 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).

    Objective measures Sleep records collected from the Xiaomi Mi wearable wristbands encompass various metrics, including duration (measured as sleep time and wake time) and a sleep quality score (ranging from 0 to 100, where a higher score indicates better sleep quality), as well as light sleep, deep sleep (in hours and percentage), and rapid eye movement sleep (in hours and percentage).

    Subjective measures The Chinese version of the 19-item Pittsburgh Quality Sleep Index is adopted to examine subjective sleep quality and disturbance over the past month. The 19-item Pittsburgh Quality Sleep Index consists of seven components, which add up to a total score from 0 to 21. Higher scores indicate poorer sleep quality.

  3. 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).

    Subjective measures The Chinese version of the World Health Organization's five-item Well-Being Index is used to measure mental well-being among participants. The total score ranges from 0 to 25, with higher total scores indicating greater well-being. The Chinese version of World Health Organization's five-item Well-Being Index has good psychometric properties.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Lau, PhD

CONTACT

[email protected]

(852) 39436222

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Hospital Authority, Hong Kong

Registry information

Official study 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

Acronym: WeLove RCT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.