N/A
N=117
Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04566861 ↗Enrolled (actual)
117
Serious AEs
36.8%
Results posted
Nov 2024
Primary outcome: Primary: Peripheral Markers of Inflammation — 17.09; 20.22; 14.79; 11.78 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peripheral Markers of Inflammation |
17.09; 20.22; 14.79; 11.78; 12.12; 11.65 | — |
| PRIMARY Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum |
-0.3796214; -0.3828328; -0.2820709; 2.825177; 3.149545; 3.048794 | — |
| PRIMARY Allopregnanolone Levels Predicting Postpartum Depression |
-0.004127186; -0.8292861; -0.4591347; -0.08843005; -0.1739193 | — |
| PRIMARY Allopregnanolone (ALLO) and Immune Function |
0.607838873; 0.508436643; 0.731221724; 0.943495625; 0.962951805; 0.32767424 | — |
| SECONDARY Birth Outcomes |
5; 3; 3; 5; 6; 8 | — |
| SECONDARY Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) |
0; 0; 0; 3; 2; 1 | — |
Summary
As a supplement to the ongoing randomized evaluation of the Cognitive Behavioral Therapy (CBT) anxiety prevention intervention in Pakistan (R01-MH111859), the investigators propose to explore potential biological mechanisms (related to inflammation and endocrine functioning) of antenatal anxiety through additional data collection with 300 pregnant women.
Eligibility Criteria
Inclusion Criteria
- ability to understand spoken Urdu
- pregnant, ≤22 weeks' gestation
- age ≥18 years
- residence ≤20 km of Holy Family Hospital
- intent to reside in the study areas until the completion of the study
Exclusion Criteria
- Current anemia
- Current major depressive episode (MDE on SCID) or life-threatening health conditions including e.g. active severe depression or suicidal ideation
- Self-report of past or current significant learning disability
- Self-report of past or current psychiatric disorder (e.g. bipolar disorder or schizophrenia) or psychiatric care (e.g. current use of anxiolytic drug and/or other psychotropic drug)
- medical disorders or severe maternal morbidity that require inpatient management that would preclude participation (101)
- ICU admission indicated by diagnosis (not only for assessment)
Data sourced from ClinicalTrials.gov (NCT04566861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.