Perinatal DepressionNCT06672432
Preventing Perinatal Depression with an App-Based CBT Program
A study testing CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program) in people with Perinatal Depression and Disease Prevention, run by Jintang County Maternal and Child Health Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if CareMom, a mobile app-based cognitive behavioral therapy program works to prevent perinatal depression among Chinese mothers. The main questions the trial aims to answer are: 1. Does CareMom lower depression scores after an 8-week intervention? 2. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Disease Prevention
- What is being tested?
- CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- Nov 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-45 years
- at 20-24 weeks of gestation
- at risk of depression but not experiencing severe depressive symptoms at recruitment, as indicated by an Edinburgh Postnatal Depression Scale (EPDS) score of between 5 and 12
- own a smartphone
- are able to independently engage with the program
Who cannot join
- have serious medical conditions or pregnancy complications that may affect their psychological condition, as determined by their medical doctor
- have a prior diagnosis of any mental disorders
- are currently or were recently (within the past six months) receiving any kinds of psychological services or treatments
- have a history of self-harm or suicide
- have any suicidal thoughts in the past 12 months
- experienced fetal deaths in the past 18 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jintang County Maternity and Child Health Hospital
Chengdu, Sichuan, 610499
Hua Qing, +86-28-84982031, 269909312@qq.com
About this study
Official title: Preventing Perinatal Depression Using an App-based Cognitive Behavioral Therapy Program
The goal of this clinical trial is to learn if CareMom, a mobile app-based cognitive behavioral therapy program works to prevent perinatal depression among Chinese mothers. The main questions the trial aims to answer are:
- Does CareMom lower depression scores after an 8-week intervention?
- Does CareMom lower depression scores at 6 weeks after childbirth?
- How satisfied are participants with CareMom?
- What unfavorable events, if any, are associated with the use of CareMom?
Read more
Researchers will compare CareMom to a matched attention control (a mobile app-based program that offers participants a similar level of interaction and daily activities) to see if CareMom works to prevent perinatal depression.
Participants will:
- Engage in the CareMom program or a relaxation training program every day for 8 weeks
- Complete a series of online questionnaire tests before and after the 8-week intervention.
- Report any discomfort experienced throughout the study period.
Read the detailed description
A two-arm parallel randomised controlled trial of 290 pregnant women will be conducted at Jintang County Maternity and Child Health Hospital of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 20-24 weeks of gestation, and randomly allocated to either the intervention group (participate in a mobile app-based 8-week cognitive behavioral therapy program, named CareMom) or the control group (participate in a mobile app-based, attention-matched, 8-week relaxation training program) using a computer-generated random number. The primary outcomes are the changes in Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 (PHQ-9) and 7-item Generalized Anxiety Disorder (GAD-7) scores from From enrollment to the end of intervention at 8 weeks.
- Conditions
- Perinatal Depression, Disease Prevention
- Being tested
- CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program), Matched Attention Control (a mobile app-based 8-week online relaxation training program)
- Keywords
- Perinatal depression, cognitive behavioral therapy, iCBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program)Other
The intervention is divided into daily tasks spread across eight weeks, with each day involving a variety of interactive elements such as videos, text-based content, guided reflections, and mental health check-ins. If the user misses a daily challenge, she can complete that challenge in the later days. Each week has a distinct focus that progressively builds the user's skills and understanding in managing emotional health. Tasks are designed to be short yet impactful, aiming to enhance engagement and adherence.
Matched Attention Control (a mobile app-based 8-week online relaxation training program)Other
This program is designed to mirror the structure and engagement level of the intervention group, providing participants with a similar amount of interaction and daily activities. Each day, participants in the control group will complete 1-2 daily tasks focused on relaxation techniques, such as breathing exercises, mindfulness meditation, and guided imagery. Each task is brief, approximately 3 minutes in duration, making it easy for participants to incorporate into their daily routine.
| Study group | Role | What they receive |
|---|---|---|
| CareMom group | Experimental | The intervention program, CareMom, is a structured, 8-week digital intervention delivered through a WeChat mini-program in Chinese, developed by Shanghai Thoven Technology Co. Ltd., China, under the guidance of psychologists and psychiatrists. CareMom is designed to support perinatal mental health by providing daily challenges, educational content, and interactive exercises that target cognitive restructuring, behavioral activation, and worry management, key therapeutic components for alleviating symptoms of depression and anxiety. Participants in the intervention group will also receive standard perinatal care throughout the study. This includes routine prenatal check-ups, postpartum nursing care, and scheduled postnatal visits, ensuring that all participants receive the essential healthcare services typically provided during the perinatal period. Receives: Other: CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program) |
| Control group | Active comparator | The control group in this study will participate in an attention-matched, 8-week online relaxation training program delivered through a mobile application. Participants in the control group will also continue to receive standard perinatal care. This standard care is not altered or influenced by participation in the study, ensuring that all participants receive the usual care necessary for perinatal health. Receives: Other: Matched Attention Control (a mobile app-based 8-week online relaxation training program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depression score at 6 weeks postpartum
Changes in Edinburgh Postnatal Depression Scale (EPDS) score. EPDS consists of 10 items rated on a four-point scale from 0 to 3, with a maximum score of 30, where higher scores indicate more severe depressive symptoms. We will use the Chinese version of EPDS in this study.
Measured: From enrollment to 6 weeks postpartum
Changes in depression score at 6 weeks postpartum
Changes in Patient Health Questionnaire-9 (PHQ-9) score.The total scores of PHQ-9 range from 0 to 27, with a score of 10 or greater being the most common cut-off for screening major depressive disorder. We will use the Chinese version of the PHQ-9 in this study.
Measured: From enrollment to 6 weeks postpartum
Changes in anxiety score at 6 weeks postpartum
Changes in Generalized Anxiety Disorder 7-item (GAD-7) score. GAD-7 consists of seven items, each rated on a score from 0 to 3. The total score ranges from 0 to 21, with higher scores reflecting more severe anxiety symptoms. In our study, the Chinese version of GAD-7 is applied.
Measured: From enrollment to 6 weeks postpartum
Secondary outcomes (5)
Changes in depression score at post-intervention
Changes in Edinburgh Postnatal Depression Scale (EPDS) score. EPDS consists of 10 items rated on a four-point scale from 0 to 3, with a maximum score of 30, where higher scores indicate more severe depressive symptoms. We will use the Chinese version of EPDS in this study.
Measured: From enrollment to the end of intervention at 8 weeks
Changes in depression score at post-intervention
Changes in Patient Health Questionnaire-9 (PHQ-9) score.The total scores of PHQ-9 range from 0 to 27, with a score of 10 or greater being the most common cut-off for screening major depressive disorder. We will use the Chinese version of the PHQ-9 in this study.
Measured: From enrollment to the end of intervention at 8 weeks
Changes in anxiety score at post-intervention
Changes in Generalized Anxiety Disorder 7-item (GAD-7) score. GAD-7 consists of seven items, each rated on a score from 0 to 3. The total score ranges from 0 to 21, with higher scores reflecting more severe anxiety symptoms. In our study, the Chinese version of GAD-7 is applied.
Measured: From enrollment to the end of intervention at 8 weeks
Comparisons of satisfaction level
Comparisons of Client Satisfaction Questionnaire (CSQ-8) results between the two groups. CSQ-8 consists of 8 items, resulting in scores that range from 8 to 32, with each item evaluated on a Likert scale; higher scores reflect greater levels of satisfaction.
Measured: From enrollment to the end of intervention at 8 weeks
Comparisons of adverse events
Comparisons of adverse events between the two groups
Measured: From enrollment to the end of intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jintang County Maternal and Child Health Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Women's and Children's Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672432
- Sponsor's protocol ID
- 20240511-1
- Other IDs
- 2024673
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may not be shared due to privacy concerns and the need to protect sensitive information. However, we are open to sharing IPD upon reasonable request, ensuring that appropriate safeguards are in place to maintain participant confidentiality and comply with relevant regulations.
Publications
Tang L, Qing H, Li H, Liu C, Wang H, Sun Y, Tan Q, Wu Y, Xiao Y, Lai J, Wang L, Zhong L, Huang F, Li C. Reducing the risk of perinatal depression using an app-based cognitive behavioral therapy program: protocol of a randomized controlled trial. Front Psychiatry. 2025 Apr 14;16:1544753. doi: 10.3389/fpsyt.2025.1544753. eCollection 2025.
PubMed 40297330
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Perinatal Depression Using an App-based Cognitive Behavioral Therapy Program
- ClinicalTrials.gov ID
- NCT06672432
- Acronym / sponsor ID
- 20240511-1
- Conditions
- Perinatal Depression, Disease Prevention
- Keywords
- Perinatal depression, cognitive behavioral therapy, iCBT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Jintang County Maternal and Child Health HospitalUniversity, hospital or other
- Collaborators
- Chengdu Women's and Children's Central Hospital
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 4 Nov 2024 (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.
The goal of this clinical trial is to learn if CareMom, a mobile app-based cognitive behavioral therapy program works to prevent perinatal depression among Chinese mothers. The main questions the trial aims to answer are:
- Does CareMom lower depression scores after an 8-week intervention?
- Does CareMom lower depression scores at 6 weeks after childbirth?
- How satisfied are participants with CareMom?
- What unfavorable events, if any, are associated with the use of CareMom?
Researchers will compare CareMom to a matched attention control (a mobile app-based program that offers participants a similar level of interaction and daily activities) to see if CareMom works to prevent perinatal depression.
Participants will:
- Engage in the CareMom program or a relaxation training program every day for 8 weeks
- Complete a series of online questionnaire tests before and after the 8-week intervention.
- Report any discomfort experienced throughout the study period.
Detailed description
A two-arm parallel randomised controlled trial of 290 pregnant women will be conducted at Jintang County Maternity and Child Health Hospital of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 20-24 weeks of gestation, and randomly allocated to either the intervention group (participate in a mobile app-based 8-week cognitive behavioral therapy program, named CareMom) or the control group (participate in a mobile app-based, attention-matched, 8-week relaxation training program) using a computer-generated random number. The primary outcomes are the changes in Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 (PHQ-9) and 7-item Generalized Anxiety Disorder (GAD-7) scores from From enrollment to the end of intervention at 8 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CareMom group | Experimental | Other: CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program)The intervention program, CareMom, is a structured, 8-week digital intervention delivered through a WeChat mini-program in Chinese, developed by Shanghai Thoven Technology Co. Ltd., China, under the guidance of psychologists and psychiatrists. CareMom is designed to support perinatal mental health by providing daily challenges, educational content, and interactive exercises that target cognitive restructuring, behavioral activation, and worry management, key therapeutic components for alleviating symptoms of depression and anxiety. Participants in the intervention group will also receive standard perinatal care throughout the study. This includes routine prenatal check-ups, postpartum nursing care, and scheduled postnatal visits, ensuring that all participants receive the essential healthcare services typically provided during the perinatal period. |
| Control group | Active comparator | Other: Matched Attention Control (a mobile app-based 8-week online relaxation training program)The control group in this study will participate in an attention-matched, 8-week online relaxation training program delivered through a mobile application. Participants in the control group will also continue to receive standard perinatal care. This standard care is not altered or influenced by participation in the study, ensuring that all participants receive the usual care necessary for perinatal health. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18-45 years
- at 20-24 weeks of gestation
- at risk of depression but not experiencing severe depressive symptoms at recruitment, as indicated by an Edinburgh Postnatal Depression Scale (EPDS) score of between 5 and 12
- own a smartphone
- are able to independently engage with the program
Key exclusion criteria (6 listed)
- have serious medical conditions or pregnancy complications that may affect their psychological condition, as determined by their medical doctor
- have a prior diagnosis of any mental disorders
- are currently or were recently (within the past six months) receiving any kinds of psychological services or treatments
- have a history of self-harm or suicide
- have any suicidal thoughts in the past 12 months
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 |
|---|---|---|
| CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program)The intervention is divided into daily tasks spread across eight weeks, with each day involving a variety of interactive elements such as videos, text-based content, guided reflections, and mental health check-ins. If the user misses a daily challenge, she can complete that challenge in the later days. Each week has a distinct focus that progressively builds the user's skills and understanding in managing emotional health. Tasks are designed to be short yet impactful, aiming to enhance engagement and adherence. | Other | CareMom group |
| Matched Attention Control (a mobile app-based 8-week online relaxation training program)This program is designed to mirror the structure and engagement level of the intervention group, providing participants with a similar amount of interaction and daily activities. Each day, participants in the control group will complete 1-2 daily tasks focused on relaxation techniques, such as breathing exercises, mindfulness meditation, and guided imagery. Each task is brief, approximately 3 minutes in duration, making it easy for participants to incorporate into their daily routine. | Other | Control group |
Primary outcome
Changes in depression score at 6 weeks postpartum
Time frame: From enrollment to 6 weeks postpartum
Changes in Edinburgh Postnatal Depression Scale (EPDS) score. EPDS consists of 10 items rated on a four-point scale from 0 to 3, with a maximum score of 30, where higher scores indicate more severe depressive symptoms. We will use the Chinese version of EPDS in this study.
Changes in depression score at 6 weeks postpartum
Time frame: From enrollment to 6 weeks postpartum
Changes in Patient Health Questionnaire-9 (PHQ-9) score.The total scores of PHQ-9 range from 0 to 27, with a score of 10 or greater being the most common cut-off for screening major depressive disorder. We will use the Chinese version of the PHQ-9 in this study.
Changes in anxiety score at 6 weeks postpartum
Time frame: From enrollment to 6 weeks postpartum
Changes in Generalized Anxiety Disorder 7-item (GAD-7) score. GAD-7 consists of seven items, each rated on a score from 0 to 3. The total score ranges from 0 to 21, with higher scores reflecting more severe anxiety symptoms. In our study, the Chinese version of GAD-7 is applied.
5 secondary outcomes
Changes in depression score at post-intervention
Time frame: From enrollment to the end of intervention at 8 weeks
Changes in depression score at post-intervention
Time frame: From enrollment to the end of intervention at 8 weeks
Changes in anxiety score at post-intervention
Time frame: From enrollment to the end of intervention at 8 weeks
Comparisons of satisfaction level
Time frame: From enrollment to the end of intervention at 8 weeks
Comparisons of adverse events
Time frame: From enrollment to the end of intervention at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Derived from this study: PubMed 40297330Tang L, Qing H, Li H, Liu C, Wang H, Sun Y, Tan Q, Wu Y, Xiao Y, Lai J, Wang L, Zhong L, Huang F, Li C. Reducing the risk of perinatal depression using an app-based cognitive behavioral therapy program: protocol of a randomized controlled trial. Front Psychiatry. 2025 Apr 14;16:1544753. doi: 10.3389/fpsyt.2025.1544753. eCollection 2025.
- Individual participant dataSharing planned: No. IPD may not be shared due to privacy concerns and the need to protect sensitive information. However, we are open to sharing IPD upon reasonable request, ensuring that appropriate safeguards are in place to maintain participant confidentiality and comply with relevant regulations.
Related trials for Perinatal Depression
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareMom (a mobile app-based 8-wekk cognitive behavioral therapy program) in people with Perinatal Depression and Disease Prevention, run by Jintang County Maternal and Child Health Hospital 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunrong Li, PhD (+8618084859927, cdlcr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depression score at 6 weeks postpartum (time frame: From enrollment to 6 weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06672432, which also lists 1 linked publication.
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 4 Nov 2024.