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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Psychological; Sleep Problems; Well-Being, Psychological

Treatments: Behavioral: WhatsApp-based psycho-socio-educational intervention (WeLove); Behavioral: WhatsApp as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT06768190

RS-2023-LY

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Intervention group 1

Experimental group

Description:

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.

Treatment:

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

Intervention group 2

Experimental group

Description:

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.

Treatment:

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

Control

Placebo Comparator group

Description:

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

Treatment:

Behavioral: WhatsApp as usual