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

NCT07736378 | Not Yet Recruiting

• 1 other identifier: HMRF Ref: 23241531
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sleep Problems; Psychological; Well-Being, Psychological

Keywords

Couple-based intervention; Psycho-socio-educational intervention (WeLove); Psychological well-being; Sleep outcome

Outcome Measures

Primary Outcomes (1)

• Psychological distress for perinatal women (objective and subjective)

  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.

  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 Outcomes (3)

• Psychological distress for partners (objective and subjective)

  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)

  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)

  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).

Study Arms (3)

WeLove Intervention for Couples

EXPERIMENTAL

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.

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

WeLove Intervention for Women Only

EXPERIMENTAL

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

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

Control group

NO INTERVENTION

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.

Interventions

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.

WeLove Intervention for Couples; WeLove Intervention for Women Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

MeSH Terms

Conditions

Parasomnias; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Central Study Contacts

Ying Lau, PhD

CONTACT

(852) 39436222; yinglau@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistants who recruit the participants or analyze data are blinded to the group assignment. Therefore, this is a single-blinded study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective randomized three-arm, parallel-group design

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 30, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): July 14, 2029
• Study Completion (Estimated): July 14, 2030
• Last Updated: July 30, 2026

Record last verified: 2026-07