A Randomized Controlled Trial of the "Psychological Training Camp & Obstetrician-Led Psychoprenatal Intervention (PICONI)" Stepwise Intervention Model for Depression and Anxiety During Pregnancy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care.
- Who it may be relevant to
- Registry conditions: Perinatal Depression, Stepped Care, Perinatal Anxiety. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Combination product "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care
Simple and scientific advice
Primary outcome measures
- Edinburgh Postnatal Depression Scale [Time frame: 42 days postpartum]
Secondary outcome measures (2)
- Generalized Anxiety Disorder, Ages and Stages Questionnaires, Maternal Postnatal Attachment Scale [Time frame: late pregnancy, 42 days postpartum, three months postpartum, six months postpartum]
- World Health Organization Five-item Well-Being Index [Time frame: late pregnancy, 42 days postpartum]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Suffering from depression being treated with psychotherapy or medication
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ma'anshan Maternal and Child Health Center — Ma’anshan
Identifiers
NCT: NCT06383221 · 83244570