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

NCT04566861 | Completed Results DMC

• 1 other identifier: 3R01MH111859-03S1
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

randomized controlled trial; inflammation; hormones

Outcome Measures

Primary Outcomes (4)

• Peripheral Markers of Inflammation

  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

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

• Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum

  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).

  trimester 2, trimester 3, 6 weeks postpartum

• Allopregnanolone Levels Predicting Postpartum Depression

  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.

  Trimester 2

• Allopregnanolone (ALLO) and Immune Function

  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))

  trimester 2, trimester 3, 6 weeks postpartum

Secondary Outcomes (2)

• Birth Outcomes

  at birth

• Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)

  6 weeks postpartum

Study Arms (3)

Anxious pregnant women - intervention group

EXPERIMENTAL

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)

Behavioral: Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy

Anxious pregnant women - enhanced usual care group

NO INTERVENTION

100 pregnant women who have at least mild anxiety will be randomized to the enhanced usual care group. Reminder calls were given, provider visits were facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the other group).

Non-anxious pregnant women - healthy control

NO INTERVENTION

100 pregnant women who do not have symptoms of anxiety or depression be followed in the healthy control group. Reminder calls were given, provider visits were facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the other groups).

Interventions

Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy BEHAVIORAL

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.

Anxious pregnant women - intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women and their children
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Human Development Research Foundation, Pakistan: collaborator
• Rawalpindi Medical College, Pakistan: collaborator
• University of Liverpool: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Holy Family Hospital

Rawalpindi, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 31998151 BACKGROUND

• 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.

  PMID: 37040167 BACKGROUND

• 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.

  PMID: 32300002 RESULT

• Etyemez S, Mehta K, Tutino E, Zaidi A, Atif N, Rahman A, Malik A, Voegtline KM, Surkan PJ, Osborne LM. The immune phenotype of perinatal anxiety in an anxiety-focused behavioral intervention program in Pakistan. Brain Behav Immun. 2024 Aug;120:141-150. doi: 10.1016/j.bbi.2024.05.028. Epub 2024 May 21.

  PMID: 38777289 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Inflammation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The original sample size target was 300 for this biological supplement study. However, the study was delayed because of Covid-19 pandemic lockdowns in Pakistan and forced to end at the same time as the main study. This prevented us from collecting all the anticipated data, leaving us with a sample size of 117.

Results Point of Contact

• Title: Dr. Pamela Surkan
• Organization: Johns Hopkins Bloomberg School of Public Health

psurkan@jhu.edu

4105027396

Study Officials

• Pamela J Surkan, ScD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The principal investigators and outcomes assessors will be blind to the randomization status of the 200 anxious women assigned to the intervention and enhanced usual care groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: October 20, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol, statistical analysis plan and informed consent form are available upon request now.
• Access Criteria: The can be access upon request from the study PI: psurkan@jhu.edu

Locations

PA (1)