Who is sponsoring NCT04566861?

NCT04566861 is sponsored by Johns Hopkins Bloomberg School of Public Health.

What drugs are being tested in NCT04566861?

Interventions in NCT04566861: Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy.

Is NCT04566861 still recruiting?

NCT04566861 is currently completed. Last updated 20 November 2024.

Are results published for NCT04566861?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-11-20 · How we verify

NCT04566861: HMHB-Bio

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 20 November 2024

What this trial tests

NA trial testing Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy in Anxiety in 117 participants. Completed in 31 August 2022.

Timeline

20 October 2020

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	117
Start date	20 October 2020
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	1 location across Pakistan

Drugs / interventions tested

Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy

Conditions studied

Anxiety — all drugs for Anxiety →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

18 and older, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Peripheral Markers of Inflammation Primary · trimester 1, trimester 2, trimester 3, 6 weeks postpartum

Differences in levels of peripheral inflammatory markers and change in these markers across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious and healthy women, and between intervention and control women. Markers include IFNgamma, IL6, IL8, IL10, IL12p70, TNFalpha, IL17A, TARC, MIP1alpha, MCP4, Eotaxin

TARC at T1

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	17.09	± 10.30
Anxious Pregnant Women - Enhanced Usual Care Group	20.22	± 10.85
Non-anxious Pregnant Women - Healthy Control	14.79	± 8.06

TARC at T2

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	11.78	± 8.30
Anxious Pregnant Women - Enhanced Usual Care Group	12.12	± 7.18
Non-anxious Pregnant Women - Healthy Control	11.65	± 7.87

TARC at T3

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	6.06	± 2.95
Anxious Pregnant Women - Enhanced Usual Care Group	7.52	± 3.29
Non-anxious Pregnant Women - Healthy Control	6.65	± 3.35

TARC at PP

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	15.28	± 6.40
Anxious Pregnant Women - Enhanced Usual Care Group	18.07	± 8.84
Non-anxious Pregnant Women - Healthy Control	16.81	± 11.03

MIP1alpha at T1

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	2.52	± 1.61
Anxious Pregnant Women - Enhanced Usual Care Group	2.17	± 0.75
Non-anxious Pregnant Women - Healthy Control	2.16	± 0.74

MIP1alpha at T2

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	4.09	± 4.33
Anxious Pregnant Women - Enhanced Usual Care Group	2.93	± 1.45
Non-anxious Pregnant Women - Healthy Control	3.41	± 1.43

MIP1alpha at T3

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	2.45	± 0.99
Anxious Pregnant Women - Enhanced Usual Care Group	2.22	± 0.60
Non-anxious Pregnant Women - Healthy Control	2.28	± 1.02

MIP1alpha at PP

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	3.62	± 0.83
Anxious Pregnant Women - Enhanced Usual Care Group	3.23	± 0.83
Non-anxious Pregnant Women - Healthy Control	3.54	± 0.99

Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum Primary · trimester 2, trimester 3, 6 weeks postpartum

Measure differences in level of allopregnanolone (mean) at each time point and across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious women and healthy women, and between intervention and control. The results are measured by log-transformed values of the concentration of each cytokine in the plasma, in ng/mL (nanogram per milliliter).

Allopregnanolone at T2

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	-0.3796214	± 0.7621596
Anxious Pregnant Women - Enhanced Usual Care Group	-0.3828328	± 0.8335611
Non-anxious Pregnant Women - Healthy Control	-0.2820709	± 0.9410302

Allopregnanolone at T3

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	2.825177	± 0.995552
Anxious Pregnant Women - Enhanced Usual Care Group	3.149545	± 0.3715666
Non-anxious Pregnant Women - Healthy Control	3.048794	± 0.3715666

Allopregnanolone at W6

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	-0.592519	± 0.5954829
Anxious Pregnant Women - Enhanced Usual Care Group	-0.6423627	± 0.5764104
Non-anxious Pregnant Women - Healthy Control	-0.7948805	± 0.4380674

Allopregnanolone Levels Predicting Postpartum Depression Primary · Trimester 2

Differences in allopregnanolone levels at the second trimester between women who do and do not go on to develop postpartum depression (PPD). The results are measured by log-transformed values of the concentration of allopregnanolone in the plasma, in ng/ml (nanogram per milliliter. Women who have Allopregnanolone (ALLO) levels and developed PPD are analyzed.

Allopregnanolone at T2 in women with PPD

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	-0.004127186	± 0.7631303
Anxious Pregnant Women - Enhanced Usual Care Group	-0.8292861	± 0.7694288

Allopregnanolone at T2 in women without PPD

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	-0.4591347	± 0.7616261
Anxious Pregnant Women - Enhanced Usual Care Group	-0.08843005	± 0.7569726
Non-anxious Pregnant Women - Healthy Control	-0.1739193	± 0.9115309

Allopregnanolone (ALLO) and Immune Function Primary · trimester 2, trimester 3, 6 weeks postpartum

Measure the relationship between ALLO levels and levels of peripheral inflammatory markers across time (trimester 2 (T2), trimester 3 (T3) and 6 weeks postpartum (W6))

T2 Allo and T2_EOTAXIN

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	0.607838873
Anxious Pregnant Women - Enhanced Usual Care Group	0.508436643
Non-anxious Pregnant Women - Healthy Control	0.731221724

T2 Allo and T2_IFNgam

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	0.943495625
Anxious Pregnant Women - Enhanced Usual Care Group	0.962951805
Non-anxious Pregnant Women - Healthy Control	0.32767424

T2 Allo and T2_IL10

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	0.442764509
Anxious Pregnant Women - Enhanced Usual Care Group	0.852343415
Non-anxious Pregnant Women - Healthy Control	0.251810201

T2 Allo and T2_IL12P70

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	0.043026211
Anxious Pregnant Women - Enhanced Usual Care Group	0.182583506
Non-anxious Pregnant Women - Healthy Control	0.032112919

T2 Allo and T2_IL17A

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	0.994071069
Anxious Pregnant Women - Enhanced Usual Care Group	0.628278059
Non-anxious Pregnant Women - Healthy Control	0.155033717

T2 Allo and T2_IL6

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	0.661240061
Anxious Pregnant Women - Enhanced Usual Care Group	0.433900134
Non-anxious Pregnant Women - Healthy Control	0.101928485

T2 Allo and T2_IL8

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	0.58507263
Anxious Pregnant Women - Enhanced Usual Care Group	0.377422318
Non-anxious Pregnant Women - Healthy Control	0.000902406

T2 Allo and T2_MCP4

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	0.253876939
Anxious Pregnant Women - Enhanced Usual Care Group	0.975614712
Non-anxious Pregnant Women - Healthy Control	0.261553

Birth Outcomes Secondary · at birth

Differences in birth outcomes (preterm birth, small for gestational age, low birth weight) between women with high inflammatory markers vs. those low in inflammatory markers, and also between anxious and healthy women.

preterm birth

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	5
Anxious Pregnant Women - Enhanced Usual Care Group	3
Non-anxious Pregnant Women - Healthy Control	3

small for gestational age

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	5
Anxious Pregnant Women - Enhanced Usual Care Group	6
Non-anxious Pregnant Women - Healthy Control	8

low birth weight

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	11
Anxious Pregnant Women - Enhanced Usual Care Group	8
Non-anxious Pregnant Women - Healthy Control	13

Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) Secondary · 6 weeks postpartum

Measure infant neuro-development using Ages \& Stages Questionnaire to measure differences in infant neurodevelopment (communication, gross motor, fine motor, personal-social and problem solving) using a standardized questionnaire between those high in inflammatory markers vs. those low, and also between anxious and healthy women communication cut-off score 22.77 gross motor cut-off score 41.84 fine motor cut-off score 30.16 personal-social cut-off score 24.62 problem solving cut-off score 33.71 Number of participants with impaired neuron-developmental infants (below cut-off scores) are repo

communication below cut-off score

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	0
Anxious Pregnant Women - Enhanced Usual Care Group	0
Non-anxious Pregnant Women - Healthy Control	0

gross motor below cut-off score

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	3
Anxious Pregnant Women - Enhanced Usual Care Group	2
Non-anxious Pregnant Women - Healthy Control	1

fine motor below cut-off score

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	1
Anxious Pregnant Women - Enhanced Usual Care Group	0
Non-anxious Pregnant Women - Healthy Control	0

personal-social below cut-off score

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	1
Anxious Pregnant Women - Enhanced Usual Care Group	0
Non-anxious Pregnant Women - Healthy Control	0

problem solving below cut-off score

Group	Value	95% CI
Anxious Pregnant Women - Intervention Group	1
Anxious Pregnant Women - Enhanced Usual Care Group	0
Non-anxious Pregnant Women - Healthy Control	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Anxious Pregnant Women - Intervention Group

Serious: 9/26 (35%)

Deaths: 0/26

Anxious Pregnant Women - Enhanced Usual Care Group

Serious: 14/31 (45%)

Deaths: 0/31

Non-anxious Pregnant Women - Healthy Control

Serious: 20/60 (33%)

Deaths: 0/60

Serious adverse events (3 terms)

Reaction	System	Anxious Pregnant Women - I…	Anxious Pregnant Women - E…	Non-anxious Pregnant Women…
Miscarriage	Pregnancy, puerperium and perinatal conditions	—	—	—
Child death	Pregnancy, puerperium and perinatal conditions	—	—	—
Still birth	Pregnancy, puerperium and perinatal conditions	—	—	—

Most-reported serious reactions: Miscarriage, Child death, Still birth.

Data from ClinicalTrials.gov NCT04566861 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The immune phenotype of perinatal anxiety in an anxiety-focused behavioral intervention program in Pakistan.
Etyemez S, Mehta K, Tutino E, Zaidi A, et al · · 2024 · cited 5× · PMID 38777289 · DOI 10.1016/j.bbi.2024.05.028

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04566861 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health
Last refreshed: 20 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04566861.

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