Evaluation of a Couple-based Psycho-socio-educational Intervention Using WeChat/WhatsApp on Dyadic Psychological and Sleep Outcomes (WeLove RCT)
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.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ying Lau, PhD
- Telefonnummer: (852) 39436222
- E-post: yinglau@cuhk.edu.hk
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: WeLove Intervention for Couples
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.
|
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.
|
|
Experimentell: WeLove Intervention for Women Only
Only pregnant women will participate in a six-week WeLove intervention.
All contents are the same as in intervention group 1.
|
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.
|
|
Inget ingripande: Control group
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Psychological distress for perinatal women (objective and subjective)
Tidsram: 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. |
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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Psychological distress for partners (objective and subjective)
Tidsram: 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. |
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)
Tidsram: 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. |
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)
Tidsram: 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.
|
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).
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HMRF Ref: 23241531
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .