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 (WhatsApp-based)

January 21, 2025 updated by: Lau Ying, Chinese University of Hong Kong

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
Placebo Comparator: Control
In the control group, pregnant women and their partners are instructed to use WhatsApp as normal for six weeks.
Behavioral: WhatsApp as usual
Pregnant women and their partners are instructed to use WhatsApp as normal for six weeks.
Other Names:
  • WhatsApp for couple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological outcome: Depression, anxiety and stress symptoms
Time Frame: Baseline, pre-intervention and immediately after the intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep outcomes: Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction
Time Frame: Baseline, pre-intervention and immediately after the intervention
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
Baseline, pre-intervention and immediately after the intervention
Psychological well-being: Subjective well-being
Time Frame: Baseline, pre-intervention and immediately after the intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Hospital Authority, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS-2023-LY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data collection is not start yet and our research team does not decide the plan to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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