Clinical trial NCT04566861: Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy
Official title: Biological Processes Underlying Anxiety During Pregnancy: A Substudy of an Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: randomized controlled trial
inflammation
hormones
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Human Development Research Foundation, Pakistan
name: Rawalpindi Medical College, Pakistan
name: University of Liverpool
name: National Institute of Mental Health (NIMH)
First posted: 2020-09-28
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within women in a larger randomized trial (randomized to the intervention or enhanced care group), we propose to study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), we will also include 100 healthy women without anxiety or depression. These enrollment goals were modified after interruptions by the Covid-19 pandemic.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: This study will leverage the ongoing randomized evaluation of the CBT anxiety prevention intervention in Pakistan (R01-MH111859) to explore potential biological mechanisms. This CBT intervention targets both sub-threshold anxiety symptoms and generalized anxiety disorder (GAD) in early- to mid- pregnancy, aiming to both prevent and treat Common Mental Disorders (CMDs) (GAD and major depressive episodes (MDE)) as well as improve birth outcomes. The study team proposes to additionally study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), the study will also include 100 healthy women without anxiety or depression. The aims are to 1) characterize the "immune phenotype" of anxious women across the peripartum, specifically by measuring the relation among anxiety symptoms and peripheral markers of inflammation within and across women (both anxious and healthy) and between those receiving the intervention and control; 2) determine the relation between levels of allopregnanolone (ALLO) in pregnancy and concurrent anxiety symptoms and future symptoms of postpartum depression (PPD), 3) examine the relation between changes in immune functioning and ALLO levels in anxious pregnancy across time, 4) examine whether immune function and/or ALLO are mediators or moderators of the association between antenatal anxiety and preterm birth and/or small-for-gestational age, and 5) examine the effects of both anxiety and the intervention (including biomarkers) on infant development at six weeks postpartum.

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)

Primary outcomes:
measure: Peripheral Markers of Inflammation
timeFrame: trimester 1, trimester 2, trimester 3, 6 weeks postpartum
measure: Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum
timeFrame: trimester 2, trimester 3, 6 weeks postpartum
measure: Allopregnanolone Levels Predicting Postpartum Depression
timeFrame: Trimester 2
measure: Allopregnanolone (ALLO) and Immune Function
timeFrame: trimester 2, trimester 3, 6 weeks postpartum
Secondary outcomes:
measure: Birth Outcomes
timeFrame: at birth
measure: Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Holy Family Hospital
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Pamela J Surkan, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atif N, Nazir H, Zafar S, Chaudhri R, Atiq M, Mullany LC, Rowther AA, Malik A, Surkan PJ, Rahman A. Development of a Psychological Intervention to Address Anxiety During Pregnancy in a Low-Income Country. Front Psychiatry. 2020 Jan 10;10:927. doi: 10.3389/fpsyt.2019.00927. eCollection 2019.
citation: Sherer ML, Malik A, Osborne LM, Rowther AA, Zaidi A, Atif N, Rahman A, Kahloon LE, Salman M, Yenokyan G, Surkan PJ. Biological Mechanisms in Pregnant Women With Anxiety (Happy Mother-Healthy Baby Supplement Study): Protocol for a Longitudinal Mixed Methods Observational Study. JMIR Res Protoc. 2023 Apr 11;12:e43193. doi: 10.2196/43193.
citation: Surkan PJ, Hamdani SU, Huma ZE, Nazir H, Atif N, Rowther AA, Chaudhri R, Zafar S, Mullany LC, Malik A, Rahman A. Cognitive-behavioral therapy-based intervention to treat symptoms of anxiety in pregnancy in a prenatal clinic using non-specialist providers in Pakistan: design of a randomised trial. BMJ Open. 2020 Apr 15;10(4):e037590. doi: 10.1136/bmjopen-2020-037590.