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

NCT ID: NCT06768190

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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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

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Sleep Problems Psychological Well-Being, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded Pilot
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Intervention group 1

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.

Group Type EXPERIMENTAL

WhatsApp-based psycho-socio-educational intervention (WeLove)

Intervention Type 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.

Intervention group 2

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.

Group Type EXPERIMENTAL

WhatsApp-based psycho-socio-educational intervention (WeLove)

Intervention Type 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.

Control

In the control group, pregnant women and their partners are instructed to use WhatsApp as normal for six weeks.

Group Type PLACEBO_COMPARATOR

WhatsApp as usual

Intervention Type BEHAVIORAL

Pregnant women and their partners are instructed to use WhatsApp as normal for six weeks.

Interventions

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WhatsApp as usual

Pregnant women and their partners are instructed to use WhatsApp as normal for six weeks.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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WhatsApp for couple

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* current severe medical illnesses
* psychological and sleep disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lau Ying

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Ying Lau, PhD

Role: CONTACT

(852) 39436222

Facility Contacts

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Ying Lau, PhD

Role: primary

(852) 39436222

Other Identifiers

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RS-2023-LY

Identifier Type: -

Identifier Source: org_study_id

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