EMA and mHealth in Preventing Postpartum Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Brief psychological counselling and health education

    Behavioral

    This 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)

    Behavioral

    The 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

    Behavioral

    A 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

    Behavioral

    A 45-minute telephone counselling based on CBT.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Intervention group (EMA + IM)Experimental treatment 4 interventions
Group B: EMA groupExperimental treatment 2 interventions
Group C: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2-week postpartum

Secondary outcomes

1

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.

Time frame
4, 6, 8 weeks postpartum
2

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.

Time frame
2, 4, 6, 8 weeks postpartum
3

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.

Time frame
2, 4, 6, 8 weeks postpartum
4

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.

Time frame
2, 4, 6, 8 weeks postpartum

Other outcomes

Sponsors and contacts

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