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

NCT06768190 | Recruiting

• 1 other identifier: RS-2023-LY
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sleep Problems; Psychological; Well-Being, Psychological

Keywords

Couple-based intervention; Psycho-socio-educational intervention (WeLove); Psychological well-being; Sleep outcome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Sleep outcomes: Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction

  Baseline, pre-intervention and immediately after the intervention

• Psychological well-being: Subjective well-being

  Baseline, pre-intervention and immediately after the intervention

Study Arms (3)

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.

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.

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.

Behavioral: WhatsApp as usual

Interventions

WhatsApp as usual BEHAVIORAL

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

Also known as: WhatsApp for couple

Control

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.

Intervention group 1; Intervention group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• current severe medical illnesses
• psychological and sleep disorders

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Parasomnias; Psychological Well-Being

Interventions

Family Characteristics

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Socioeconomic Factors; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Ying Lau, PhD

CONTACT

(852) 39436222; yinglau@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double-blinded Pilot

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 10, 2025
• Study Start: January 6, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

HK (1)