Antenatal DepressionNCT07349368
Effectiveness and Cost-effectiveness of Simultaneous Screening and Intervention for Antenatal Depression and Anxiety Symptoms From a Transdiagnostic Perspective: A Scale-up Feasibility Study
A study testing implementation group in people with Antenatal Depression and Antenatal Anxiety, run by Anhui Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antenatal Depression, Antenatal Anxiety
- What is being tested?
- implementation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,314 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2021to 24 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The age was ≥18 years old pregnancy and capable of completing the independent assessment of smart phones.
Who cannot join
- Exclude those with abnormal comprehension and expression abilities
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Antenatal Depression, Antenatal Anxiety
- Being tested
- implementation group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation groupBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| usual care group | No intervention | no additional intervention |
| Stratified iCBT group | Experimental | Stratified iCBT(Internet-based Cognitive Behavioral Therapy) Intervention plus usual care Receives: Behavioral: implementation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start24 Mar 2021
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antenatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangbiao Tao, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349368
- Sponsor's protocol ID
- 20170358
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of Simultaneous Screening and Intervention for Antenatal Depression and Anxiety Symptoms From a Transdiagnostic Perspective: A Scale-up Feasibility Study
- ClinicalTrials.gov ID
- NCT07349368
- Acronym / sponsor ID
- 20170358
- Conditions
- Antenatal Depression, Antenatal Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,314 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care group | No intervention | –no additional intervention |
| Stratified iCBT group | Experimental | Behavioral: implementation groupStratified iCBT(Internet-based Cognitive Behavioral Therapy) Intervention plus usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The age was ≥18 years old pregnancy and capable of completing the independent assessment of smart phones.
Key exclusion criteria (1 listed)
- Exclude those with abnormal comprehension and expression abilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implementation group1. 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. | Behavioural | Stratified iCBT group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implementation group in people with Antenatal Depression and Antenatal Anxiety, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (EPDS) Score (time frame: at 42 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.