Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy (HMHB-Bio)
Anxiety
About this trial
This is an interventional basic science trial for Anxiety focused on measuring randomized controlled trial, inflammation, hormones
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 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)
Sites / Locations
- Holy Family Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
No Intervention
Anxious pregnant women - intervention group
Anxious pregnant women - enhanced usual care group
Non-anxious pregnant women - healthy control
100 pregnant women who have at least mild anxiety will be randomized to the intervention group where they will receive six one-on-one core sessions of Cognitive Behavioral Therapy during pregnancy (plus possible booster sessions)
100 pregnant women who have at least mild anxiety will be randomized to the enhanced usual care group. They will not receive intervention sessions but will receive transportation vouchers to come to the hospital and facilitation by study staff to attend to their regular antenatal care visits.
100 pregnant women who do not have symptoms of anxiety or depression be followed in the healthy control group. They will not receive intervention sessions but will receive transportation vouchers to come to the hospital and facilitation by study staff to attend to their regular antenatal care visits.