About this trial
This proposed study aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model that combines brief psychological counselling, Ecological Momentary Assessment (EMA), mHealth-based psychological support, and CBT-guided telephone counselling to prevent postpartum depression (PPD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women who are in their 20 to 28 weeks of gestation,
Receiving regular antenatal care service in Hong Kong,
Had a total score ≥7 in EPDS-10 (suggesting potential distress symptoms),
Able to read and understand Chinese and use an instant messaging app weekly
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Brief psychological counselling and health education
BehavioralThis is a brief 1-on-1 psychological counselling, including potential mood fluctuation during pregnancy, possible prepartum depressive symptoms, and available psychiatric consultation and medication in Hong Kong with self-help psychoeducational materials.
2 Weeks of Ecological Momentary Assessment (EMA)
BehavioralThe 2-week EMA period will start the next day. Participants will be prompted to answer questions about emotion (e.g. worry, enjoyment, anxiety, etc.) and other lifestyle and environmental triggers through the smartphone notification function. There will be a 2-hour window for each assessment before expiration and total 5 assessments a day.
10 weeks of mobile health psychological support
BehavioralA total of 20 regular instant messages (e.g., via WhatsApp) personalised by baseline demographic characteristics (current pregnancy details, history of postpartum mental illness) and results of EMA will be sent to the participants in multi-media formats.
CBT-guided telephone counselling booster
BehavioralA 45-minute telephone counselling based on CBT.
Treatment groups
Trial outcomes
Primary outcomes
Postpartum depression
Postpartum depression will be measured by Edinburgh Postnatal Depression Scale (EPDS-10). The score ranges from 0-30. 0-9 indicates minimal or no depressive symptoms.10-12 suggests mild depressive symptoms and further monitoring may be recommended.13-14 indicates moderate depressive symptoms and a potential need for further assessment.15-30 suggests significant depressive symptoms and likely clinical depression, requiring further evaluation and intervention.
Secondary outcomes
Postpartum depression
Postpartum depression will be measured by the Edinburgh Postnatal Depression Scale (EPDS-10). The score ranges from 0-30. 0-9 indicates minimal or no depressive symptoms.10-12 suggests mild depressive symptoms and further monitoring may be recommended.13-14 indicates moderate depressive symptoms and a potential need for further assessment.15-30 suggests significant depressive symptoms and likely clinical depression, requiring further evaluation and intervention.
Anxiety
Anxiety will be measured by the 7-item Generalized Anxiety Disorder (GAD-7). The total score ranges from 0 to 21. A higher score on the GAD-7 indicates greater severity of anxiety symptoms.
Depression
Depression will be measured by the 9-item Patient Health Questionnaire (PHQ-9). The total score ranges from 0 to 27. A higher score on the PHQ-9 indicates greater severity of depressive symptoms.
Stress
Self-perceived stress will be measured by the 10-item Perceived Stress Scale (PSS-10). The total score ranges from 0 to 40. A higher score on the PSS-10 indicates greater perceived stress, reflecting a higher level of distress or difficulty in managing life's challenges.
Sponsors and contacts
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