Perinatal DepressionNCT06383221
A Randomized Controlled Trial of the "Psychological Training Camp & Obstetrician-Led Psychoprenatal Intervention (PICONI)" Stepwise Intervention Model for Depression and Anxiety During Pregnancy.
A study testing "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care in people with Perinatal Depression and Stepped Care, run by Fangbiao Tao at 1 site in China.
Trial summary
In this study, pregnant women were screened and managed for depression and anxiety in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression and/or anxiety during pregnancy were dynamically enrolled in the study and stratified into randomized groups… 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
- Perinatal Depression, Stepped Care, Perinatal Anxiety
- What is being tested?
- "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 10 Jul 2026
- Phase
- Interventional
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
- Pregnant women; Informed consent, able to complete the questionnaire independently; Positive first depression screening (EPDS ≥ 10) or anxiety screening (GAD-7≥5) in early and mid pregnancy; Intention to have children in this pregnancy.
Who cannot join
- Suffering from depression being treated with psychotherapy or medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
In this study, pregnant women were screened and managed for depression and anxiety in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression and/or anxiety during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid and late), depression and/or anxiety, randomly assigned to the intervention and control groups on a 1:1 basis. Pregnant women with mild anxiety and/or depression self-study the Psychic Fitness Camp, and pregnant women with moderate-to-severe anxiety and/or depression self-study the Psychic Fitness Camp with immediate referral to an obstetrician for one to three Mood Scan. The control group received routine care.
Read the detailed description
The intervention group used the "Psychological Training Camp \& Obstetrician-Led Psychoprenatal Intervention (PICONI)" stepwise care model, which incorporated cognitive-behavioral therapy, mindfulness,etc., with the Psychic Fitness Camp being a self-help learning experience and the Mood Scan being a perinatal clinic doctor guiding pregnant women in unhealthy thinking alternatives and behavior design.
Metabolic markers of perinatal depression anxiety and the mitigating effects of the stepped care model were explored by collecting blood and urine samples from the study participants during early, mid and late pregnancy respectively, samples were collected and stored in a refrigerator at -80 degrees Celsius.
- Conditions
- Perinatal Depression, Stepped Care, Perinatal Anxiety
- Being tested
- "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step CareCombination product
Simple and scientific advice
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Pregnant women with mild anxiety and/or depression self-study the Psychic Fitness Camp, and pregnant women with moderate-to-severe anxiety and/or depression self-study the Psychic Fitness Camp with immediate referral to an obstetrician for one to three Mood Scan. Receives: Combination Product: "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care |
| control group | No intervention | The control group received routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
Assessment of the severity of depressive symptoms
Measured: 42 days postpartum
Secondary outcomes (2)
Generalized Anxiety Disorder, Ages and Stages Questionnaires, Maternal Postnatal Attachment Scale
Assessment of the severity of anxiety symptoms, birth outcome, growth and development in children, Mother-infant attachment relationship
Measured: late pregnancy, 42 days postpartum, three months postpartum, six months postpartum
World Health Organization Five-item Well-Being Index
Assessment of the Well-Being index
Measured: late pregnancy, 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 posted25 Apr 2024
- Study start20 May 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fangbiao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangbiao Tao, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383221
- Sponsor's protocol ID
- 83244570
- Status last verified
- Dec 2025
- First submitted
- 22 Apr 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided