- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Conditions
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
|
|
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.
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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.
Sponsor
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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