Sleep ProblemsWhatsApp-basedNCT06768190
WhatsApp-based Psycho-socio-educational Intervention (WeLove) for Prevention of Psychological and Sleep Problems in Pregnant Women and Their Partners: A Three-arm Double-blinded Pilot Randomised Controlled Trial
A study testing WhatsApp as usual and WhatsApp-based psycho-socio-educational intervention (WeLove) in people with Sleep Problems and Psychological, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objectives: (1) evaluate the feasibility and acceptability of the WhatsApp-based psycho-socio-educational intervention (WeLove); (2) preliminarily examine the effects of the intervention on psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction; and (3) preliminarily… 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?
- WhatsApp as usual and WhatsApp-based psycho-socio-educational intervention (WeLove)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Jan 2025to 31 Jan 2027
- 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 with a gestation of >12 to 28 weeks and their partners over 18 years
- able to read and understand Chinese
- have electronic devices with WhatsApp that can contact the Internet
- can provide written consent and voluntary participation in this study
Who cannot join
- current severe medical illnesses
- psychological and sleep disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Ying Lau, PhD, (852) 39436222, yinglau@cuhk.edu.hk
About this study
Objectives: (1) evaluate the feasibility and acceptability of the WhatsApp-based psycho-socio-educational intervention (WeLove); (2) preliminarily examine the effects of the intervention on psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction; and (3) preliminarily examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners.
Methods: The investigators will use WhatsApp to provide the six sessions of the intervention, which include psychological, social, and educational components. A three-arm double-blinded pilot randomised controlled trial (RCT) is used in 60 couples, followed by individual face-to-face interviews for process evaluation in 10 to 20 couples based on data saturation. Participants will be assigned to one of three groups and 20 couples per group: intervention 1 (couples for WeLove), intervention 2 (pregnant women for WeLove), or the control group (use WhatsApp as normal). Participants will be assessed pre- and post-intervention. Generalised estimating equation analysis and thematic analysis will be performed to examine the research objectives.
Read the detailed description
Study design A prospective randomised double-blind, 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
- WhatsApp as usual, WhatsApp-based psycho-socio-educational intervention (WeLove)
- 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.
WhatsApp as usualBehavioural
Also called WhatsApp for couple
Pregnant women and their partners are instructed to use WhatsApp as normal for six weeks.
WhatsApp-based psycho-socio-educational intervention (WeLove)Behavioural
The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation. Each session has two short videos, quizzes, forums, and homework. The content is presented through a virtual midwife using storytelling of real-life scenarios, animation, and case vignettes about psychological and sleep problems during pregnancy. A virtual midwife acts as an educator to explain the prevalence, causes, and factors of psychological and sleep problems. Every session will concentrate on certain courses and offer specialised advice to expectant mothers and their partners. Using the security links on the WhatsApp platform, each session takes 15 to 20 minutes to finish.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Experimental | In intervention group 1, pregnant women and their partners will participate in a six-week Welove intervention. The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation. Receives: Behavioral: WhatsApp-based psycho-socio-educational intervention (WeLove) |
| Intervention group 2 | Experimental | In intervention group 2, only pregnant women will participate in a six-week WeLove intervention. The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation. Receives: Behavioral: WhatsApp-based psycho-socio-educational intervention (WeLove) |
| Control | Placebo comparator | In the control group, pregnant women and their partners are instructed to use WhatsApp as normal for six weeks. Receives: Behavioral: WhatsApp as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological outcome: Depression, anxiety and stress symptoms
Depression, anxiety and stress symptoms will be assessed by the Chinese version of 21-item Depression Anxiety and Stress Scale (DASS-21). It has three subscales with seven items each: stress, anxiety, and depressive symptoms. Four-point rating scales, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), are used to categorise frequency and severity. The final scores are obtained by multiplying each subscale's values by two. Every subscale has a total score that varies from 0 to 42; a high score on any subscale denotes a higher level of stress, anxiety, and depressive symptoms
Measured: Baseline, pre-intervention and immediately after the intervention
Secondary outcomes (2)
Sleep outcomes: Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction
Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction will be assessed by the Chinese version of 19-item Pittsburgh Sleep Quality Index (PSQI). Subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disruptions, sleep medication, and daytime dysfunction are the seven components that comprise the components of the PSQI. The range of scores for each item is 0 (no difficulty) to 3 (extreme difficulty). The total score ranges between 0 and 21. Poorer quality of sleep is indicated by a higher overall score
Measured: Baseline, pre-intervention and immediately after the intervention
Psychological well-being: Subjective well-being
Subjective well-being will be measured by the Chinese version of World Health Organization-Five Well-Being Index (WHO-5). It included 5 items. Each item is rated on a six-point Likert scale, ranging from 0 (at no time) to 5 (always), the total score range from 0 to 25. A higher score indicates greater mental well-being.
Measured: Baseline, pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start6 Jan 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2027 (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
- Double-blinded Pilot
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 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
- NCT06768190
- Sponsor's protocol ID
- RS-2023-LY
- Acronym
- WhatsApp-based
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data collection is not start yet and our research team does not decide the plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WhatsApp-based Psycho-socio-educational Intervention (WeLove) for Prevention of Psychological and Sleep Problems in Pregnant Women and Their Partners: A Three-arm Double-blinded Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06768190
- Acronym / sponsor ID
- WhatsApp-based / RS-2023-LY
- 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
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 10 Jan 2025 (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.
Objectives: (1) evaluate the feasibility and acceptability of the WhatsApp-based psycho-socio-educational intervention (WeLove); (2) preliminarily examine the effects of the intervention on psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction; and (3) preliminarily examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners.
Methods: The investigators will use WhatsApp to provide the six sessions of the intervention, which include psychological, social, and educational components. A three-arm double-blinded pilot randomised controlled trial (RCT) is used in 60 couples, followed by individual face-to-face interviews for process evaluation in 10 to 20 couples based on data saturation. Participants will be assigned to one of three groups and 20 couples per group: intervention 1 (couples for WeLove), intervention 2 (pregnant women for WeLove), or the control group (use WhatsApp as normal). Participants will be assessed pre- and post-intervention. Generalised estimating equation analysis and thematic analysis will be performed to examine the research objectives.
Detailed description
Study design A prospective randomised double-blind, 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
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blinded Pilot
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Experimental | Behavioral: WhatsApp-based psycho-socio-educational intervention (WeLove)In intervention group 1, pregnant women and their partners will participate in a six-week Welove intervention. The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation. |
| Intervention group 2 | Experimental | Behavioral: WhatsApp-based psycho-socio-educational intervention (WeLove)In intervention group 2, only pregnant women will participate in a six-week WeLove intervention. The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation. |
| Control | Placebo comparator | Behavioral: WhatsApp as usualIn the control group, pregnant women and their partners are instructed to use WhatsApp as normal for six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant with a gestation of >12 to 28 weeks and their partners over 18 years
- able to read and understand Chinese
- have electronic devices with WhatsApp that can contact the Internet
- can provide written consent and voluntary participation in this study
Key exclusion criteria (2 listed)
- current severe medical illnesses
- psychological and 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 |
|---|---|---|
| WhatsApp as usualAlso: WhatsApp for couplePregnant women and their partners are instructed to use WhatsApp as normal for six weeks. | Behavioural | Control |
| WhatsApp-based psycho-socio-educational intervention (WeLove)The intervention comprises six sessions, including psychoeducation, communication training, sleep hygiene, stimulus control, cognitive restructuring, and behavioural activation. Each session has two short videos, quizzes, forums, and homework. The content is presented through a virtual midwife using storytelling of real-life scenarios, animation, and case vignettes about psychological and sleep problems during pregnancy. A virtual midwife acts as an educator to explain the prevalence, causes, and factors of psychological and sleep problems. Every session will concentrate on certain courses and offer specialised advice to expectant mothers and their partners. Using the security links on the WhatsApp platform, each session takes 15 to 20 minutes to finish. | Behavioural | Intervention group 1, Intervention group 2 |
Primary outcome
Psychological outcome: Depression, anxiety and stress symptoms
Time frame: Baseline, pre-intervention and immediately after the intervention
Depression, anxiety and stress symptoms will be assessed by the Chinese version of 21-item Depression Anxiety and Stress Scale (DASS-21). It has three subscales with seven items each: stress, anxiety, and depressive symptoms. Four-point rating scales, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), are used to categorise frequency and severity. The final scores are obtained by multiplying each subscale's values by two. Every subscale has a total score that varies from 0 to 42; a high score on any subscale denotes a higher level of stress, anxiety, and depressive symptoms
2 secondary outcomes
Sleep outcomes: Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction
Time frame: Baseline, pre-intervention and immediately after the intervention
Psychological well-being: Subjective well-being
Time frame: Baseline, pre-intervention and immediately after the 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 23 Jan 2025.
- Individual participant dataSharing planned: Undecided. The data collection is not start yet and our 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WhatsApp as usual and WhatsApp-based psycho-socio-educational intervention (WeLove) in people with Sleep Problems and Psychological, run by Chinese University of Hong Kong at 1 site in 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 outcome: Depression, anxiety and stress symptoms (time frame: Baseline, pre-intervention and immediately after the 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 23 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.