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

NCT07349368 | Completed

• 1 other identifier: 20170358
• Study Type: interventional
• Target: 3,314
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antenatal Anxiety; Antenatal Depression

Outcome Measures

Primary Outcomes (2)

• Edinburgh Postnatal Depression Scale (EPDS) Score

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

  at 42 days postpartum

• Generalized Anxiety Disorder 7-item (GAD-7) Scale Score

  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.

  at 42 days postpartum

Other Outcomes (1)

• cost-effectiveness ratios (ICER)

  at 42 days postpartum

Study Arms (2)

usual care group

NO INTERVENTION

no additional intervention

Stratified iCBT group

EXPERIMENTAL

Stratified iCBT(Internet-based Cognitive Behavioral Therapy) Intervention plus usual care

Behavioral: implementation group

Interventions

implementation group BEHAVIORAL

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.

Stratified iCBT group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Exclude those with abnormal comprehension and expression abilities

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Jieshou Maternal and Child Health Hospital

Fuyang, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 16, 2026
• Study Start: March 24, 2021
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)