Sleep ProblemsWeLove RCTNCT07736378
Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat/WhatsApp on Dyadic Psychological and Sleep Outcomes
A study testing Couple-based psycho-socio-educational intervention using WeChat/WhatsApp in people with Sleep Problems and Psychological, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Problems, Psychological, Well-Being, Psychological
- What is being tested?
- Couple-based psycho-socio-educational intervention using WeChat/WhatsApp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2026to 14 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
Read the 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).
- Conditions
- Sleep Problems, Psychological, Well-Being, Psychological
- Being tested
- Couple-based psycho-socio-educational intervention using WeChat/WhatsApp
- Keywords
- Couple-based intervention, Psycho-socio-educational intervention (WeLove), Psychological well-being, Sleep outcome
- Medical subject headings
- Parasomnias, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-based psycho-socio-educational intervention using WeChat/WhatsAppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start16 Jul 2026 (estimated)
- Primary completion14 Jul 2029 (estimated)
- Study completion14 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized three-arm, parallel-group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Lau Ying, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736378
- Sponsor's protocol ID
- HMRF Ref: 23241531
- Acronym
- WeLove RCT
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data collection has not started yet and the research team does not decide the plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07736378
- Acronym / sponsor ID
- WeLove RCT / HMRF Ref: 23241531
- Conditions
- Sleep Problems, Psychological, Well-Being, Psychological
- Keywords
- Couple-based intervention, Psycho-socio-educational intervention (WeLove), Psychological well-being, Sleep outcome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- 16 Jul 2026 (estimated)
- Primary completion
- 14 Jul 2029 (estimated)
- Study completion
- 14 Jul 2030 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective randomized three-arm, parallel-group design
| Arm | Type | Receives |
|---|---|---|
| WeLove Intervention for Couples | Experimental | Behavioral: Couple-based psycho-socio-educational intervention using WeChat/WhatsAppPregnant 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. |
| WeLove Intervention for Women Only | Experimental | Behavioral: Couple-based psycho-socio-educational intervention using WeChat/WhatsAppOnly pregnant women will participate in a six-week WeLove intervention. All contents are the same as in intervention group 1. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple-based psycho-socio-educational intervention using WeChat/WhatsAppThere 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. | Behavioural | WeLove Intervention for Couples, WeLove Intervention for Women Only |
Primary outcome
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.
3 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided. The data collection has not started yet and the research team does not decide the plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-based psycho-socio-educational intervention using WeChat/WhatsApp in people with Sleep Problems and Psychological, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Lau, PhD ((852) 39436222, yinglau@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.