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

Anxiety Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566861
• Other study ID #: 3R01MH111859-03S1
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2021
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy
Women who are randomized to the intervention group will receive six core Cognitive Behavioral Therapy (CBT) sessions for anxiety during pregnancy (and possible booster sessions) to treat symptoms of anxiety.

Locations

Country	Name	City	State
Pakistan	Holy Family Hospital	Rawalpindi

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Human Development Research Foundation, Pakistan, National Institute of Mental Health (NIMH), Rawalpindi Medical College, Pakistan, University of Liverpool

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

Nazir H, Rowther AA, Rauf N, Atiq M, Kazi AK, Malik A, Atif N, Surkan PJ. 'Those whom I have to talk to, I can't talk to': Perceived social isolation in the context of anxiety symptoms among pregnant women in Pakistan. Health Soc Care Community. 2022 Sep 19. doi: 10.1111/hsc.14019. [Epub ahead of print] — View Citation

Rauf N, Zulfiqar S, Mumtaz S, Maryam H, Shoukat R, Malik A, Rowther AA, Rahman A, Surkan PJ, Atif N. The Impact of the COVID-19 Pandemic on Pregnant Women with Perinatal Anxiety Symptoms in Pakistan: A Qualitative Study. Int J Environ Res Public Health. 2021 Aug 4;18(16). pii: 8237. doi: 10.3390/ijerph18168237. — View Citation

Rowther AA, Kazi AK, Nazir H, Atiq M, Atif N, Rauf N, Malik A, Surkan PJ. "A Woman Is a Puppet." Women's Disempowerment and Prenatal Anxiety in Pakistan: A Qualitative Study of Sources, Mitigators, and Coping Strategies for Anxiety in Pregnancy. Int J Environ Res Public Health. 2020 Jul 8;17(14). pii: E4926. doi: 10.3390/ijerph17144926. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral markers of inflammation	We will measure differences in levels of peripheral inflammatory markers and change in these markers across time between anxious and healthy women, and between intervention and control women. Markers include IL-6, CCL3, CXCL8, Eotaxin, VEGF, and GM-CSF	during pregnancy until six weeks postpartum
Primary	Allopregnanolone levels and anxiety symptoms across the peripartum	We will measure differences in level of allopregnanolone at each time point and across time between anxious women and healthy women, and between intervention and control	during pregnancy until six weeks postpartum
Primary	Allopregnanolone levels predicting postpartum depression	We will measure differences in allopregnanolone levels at the second trimester between women who do and do not go on to develop postpartum depression.	during pregnancy until birth
Primary	Allopregnanolone and immune function	We will measure the relationship between ALLO levels and levels of peripheral inflammatory markers across time, both concurrent and predictive	through pregnancy until six weeks postpartum
Secondary	Birth outcomes	We will measure differences in birth outcomes (preterm birth, small or large 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.	through pregnancy and at birth
Secondary	Infant neurodevelopment	We will measure differences in infant neurodevelopment using a standardized questionnaire between those high in inflammatory markers vs. those low, and also between anxious and healthy women	through pregnancy up to and including 6 weeks postpartum