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Completed

NCT Number: NCT07349368

Effectiveness and Cost-effectiveness of Simultaneous Screening and Intervention for Antenatal Depression and Anxiety Symptoms From a Transdiagnostic Perspective: A Scale-up Feasibility Study

This scale-up study aimed to explore the effectiveness of simultaneous screening and intervention of antenatal depression and anxiety in preventing postpartum depression and anxiety and how scale-up might be successfully achieved. The age was ≥18 years old pregnancy and capable of completing the independent assessment of smart phones. Exclude those with abnormal comprehension and expression abilities. The implementation group, 1. screening during pregnancy and 42 days postpartum; 2. Stratified iCBT Intervention, usual care. Low-intensity: Mild cases (EPDS≥9/GAD-7≥5) received 11 animated video sessions adapted from WHO's Thinking Healthy Programme manual. High-intensity: Moderate-severe cases (EPDS≥12/GAD-7≥10) received low-intensity components and supplemental telehealth counseling. The control group, screening at 42 days postpartum, usual care.

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Key information

Conditions

Antenatal Depression Antenatal Anxiety

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jieshou Maternal and Child Health Hospital

Fuyang, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The age was ≥18 years old pregnancy and capable of completing the independent assessment of smart phones.

Exclusion criteria

  • Exclude those with abnormal comprehension and expression abilities

Treatment and study plan

implementation group

Behavioral
  • screening during pregnancy and 42 days postpartum
  • Stratified iCBT Intervention, usual care Low-intensity: Mild cases (EPDS≥9/GAD-7≥5) received 11 animated video sessions adapted from WHO's Thinking Healthy Programme manual. High-intensity: Moderate-severe cases (EPDS≥12/GAD-7≥10) received low-intensity components and supplemental telehealth counseling.

Primary outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS) Score

    Time frame: at 42 days postpartum

    The EPDS is a 10-item self-report questionnaire. Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.

  2. Generalized Anxiety Disorder 7-item (GAD-7) Scale Score

    Time frame: at 42 days postpartum

    The GAD-7 is a 7-item self-report questionnaire. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.

Other outcomes

  1. cost-effectiveness ratios (ICER)

    Time frame: at 42 days postpartum

    ICER were calculated by dividing the difference in mean costs by the difference in anxiety and/or depression symptoms-free (Δcosts/Δoutcome). Cost included screening, access to the animated videos, and counselling.

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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