CompletedNot Applicable

Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy

Pakistan117 participantsStarted 2020-10-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peripheral Markers of Inflammation

Timeframe: trimester 1, trimester 2, trimester 3, 6 weeks postpartum

Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum

Timeframe: trimester 2, trimester 3, 6 weeks postpartum

Allopregnanolone Levels Predicting Postpartum Depression

Timeframe: Trimester 2

Allopregnanolone (ALLO) and Immune Function

Timeframe: trimester 2, trimester 3, 6 weeks postpartum

Trial details

NCT IDNCT04566861

SponsorJohns Hopkins Bloomberg School of Public Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-31

Results submitted2023-12-22

View on ClinicalTrials.gov More Anxiety trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Peripheral Markers of Inflammation

Timeframe: trimester 1, trimester 2, trimester 3, 6 weeks postpartum

Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum

Timeframe: trimester 2, trimester 3, 6 weeks postpartum

Allopregnanolone Levels Predicting Postpartum Depression

Timeframe: Trimester 2

Allopregnanolone (ALLO) and Immune Function

Timeframe: trimester 2, trimester 3, 6 weeks postpartum