About this trial
This pilot study will recruit 120 perinatal pregnant women and follow them up for 6 months. Both momentary and retrospective assessments of emotional well-being and psychosocial factors will be conducted on a mobile application. We aim to understand the symptom trajectories and provide evidence for effective individualized interventions.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women in their first and second trimesters.
Aged 18 years and older.
Able to read and understand Chinese
Own a smartphone with iOS or Android system.
Disqualifiers
Psychiatric diagnosis (e.g., schizophrenia, intellectual disability or mood disorders), comorbid brain conditions (history of epilepsy, stroke, or brain tumors), or learning disabilities.
Trial population
Perinatal women
Trial design
Cohort
Prospective
Treatments tested in this trial
Ecological momentary assessment and retrospective assessment
Diagnostic testThe intervention includes daily EMA components, and monthly retrospective assessments.
Treatment groups
Trial outcomes
Primary outcomes
Ecological Momentary Questions (Mood)
Three momentary questions will be administered to assess participants' mood-two yes/no Whooley questions for depression, one question about anxiety, which questions will be mapped onto a five-point pictorial scale, ranging from 1 (lowest) to 5 (highest) points. The higher score means worse outcome.
Edinburgh Postnatal Depression Scale (EPDS)
Measures postnatal depression. Each item scores 0-3, and the total score ranges from 0 (min) to 30 (max). Higher score means worse depressive symptoms.
Secondary outcomes
Ecological Momentary Questions (Lifestyle and Physical Wellbeing)
Three momentary questions will be administered to assess participants' sleep, exercise and physical pain/fatigue; they will be either mapped onto a five-point pictorial scale, ranging from 1 (min) to 5 (max) points (sleep) or presented using yes/no questions (exercise and physical pain/fatigue). For sleep, the higher score means better outcome.
Ecological Momentary Questions (Contextual)
Two contextual questions will be administered to complement the momentary mood questions. They will assess participants' location and the activity in which they are engaged at the time they answer the six momentary questions.
Depression Anxiety and Stress Scale 21 (DASS-21)
Measures stress symptoms. Each item scores 0-3, the total score for stress ranges from 0 (min) to 21 (max). Higher score means worse symptoms of stress.
Post-study acceptance survey
A questionniare at the end of the six-month study period to assess the acceptability of the app to participants in the context of their prenatal and postnatal care and to collect feedback about their experience with the app.
Sponsors and contacts
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The Hong Kong Polytechnic University
Lead sponsor
The University of Hong Kong
Collaborator