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| Name | Class |
|---|---|
| Hospital Authority, Hong Kong | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Control | Placebo Comparator | In the control group, pregnant women and their partners are instructed to use WhatsApp as normal for six weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WhatsApp as usual | Behavioral | Pregnant women and their partners are instructed to use WhatsApp as normal for six weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, pre-intervention and immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Lau, PhD | Contact | (852) 39436222 | yinglau@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
The data collection is not start yet and our research team does not decide the plan to share data.
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Double-blinded Pilot
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The randomization of participants will enable the enrolling researcher to remain blind to participant conditions throughout the trial. The research assistants evaluating the participants are blinded to the group assignment. The assistants analysing participant data are also blinded to the group assignment. The active nature of the control condition may also allow us to blind the participants to the condition. The participants will be informed that the study aims to investigate the efficacy of three conditions to improve psychological and sleep well-being. However, they will not be explicitly advised of the content or intention. This minor deception is designed to yield a double-blind trial of the intervention.
| WhatsApp-based psycho-socio-educational intervention (WeLove) | Behavioral | 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. |
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| 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. | Baseline, pre-intervention and immediately after the intervention |
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005191 | Family Characteristics |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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