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

January 11, 2026 updated by: Fangbiao Tao, Anhui Medical University
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3314

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Fuyang, China
        • Jieshou Maternal and Child Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual care group
no additional intervention
Experimental: Stratified iCBT group
Stratified iCBT(Internet-based Cognitive Behavioral Therapy) Intervention plus usual care
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 42 days postpartum
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.
at 42 days postpartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 42 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

June 24, 2022

Study Completion (Actual)

June 24, 2022

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 20170358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study does not currently plan to share individual participant data (IPD). The main reasons are: ① The study involves sensitive clinical information (e.g., scores from mental health scales), and there remains potential privacy risks even after de-identification; ② The data usage agreement does not include authorization for external sharing, and additional informed consent from study participants is required.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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