Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention

Anxiety Clinical Trial

— HMHB  

Official title:

Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880032
• Other study ID #: R01MH111859-01
• Status: Completed
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: October 7, 2022

Study information

• Verified date: February 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.

Description:

Common mental disorders (CMDs) such as anxiety and depression occur frequently in pregnancy and the postnatal period in lower- and middle income countries (LMICs). Prenatal anxiety, both subthreshold and clinical, adversely affects maternal wellbeing and outcomes among offspring, and is a major predictor of subsequent depression. Preventive approaches have enormous potential to reduce the negative effects of postnatal mental disorders in mothers and improve child outcomes. The study team proposes to create a scalable and sustainable early prevention intervention focusing on anxiety symptoms in pregnant women, to be delivered by non-specialist providers (Aim 1). The investigators will evaluate this preventive intervention through a trial by randomizing 1200 pregnant women from a public hospital in Islamabad Pakistan to either our Cognitive Behavioral Therapy-based (CBT-based) early-in-pregnancy program or to usual care. The investigators will study the effects of the intervention on 1) CMDs in the 3rd trimester of pregnancy and at 6 weeks postpartum (Aim 2) and on 2) fetal and newborn small-for-gestational age (SGA) outcomes (Aim 3). The investigators will also examine if interpersonal violence, perceived stress and social support mediate and/or modify the intervention effects on CMDs and perinatal outcomes (Aim 4). Finally, the investigators will conduct a cost-effectiveness evaluation, comparing costs and healthcare utilization for women in the prenatal intervention and enhanced usual care groups (Aim 5). Focusing on anxiety reduction is a major innovation; anxiety has not been addressed within prenatal intervention packages in LMICs, despite its association with increased postpartum depression and suboptimal fetal and infant outcomes. Pakistan has high prevalence of both women with prenatal anxiety (35% to 49%) and SGA newborns (~47%), providing an ideal research opportunity. The CBT-based approach, appropriate given its indication for anxiety and depression, is grounded in preliminary work in this population, where the investigators have previously successfully reduced postpartum depression. Intervening early in pregnancy is a further innovation that is critical for building the evidence base for preventative approaches to reduce maternal CMDs and related perinatal outcomes. The proposed mediation and effect modification analyses will improve understanding of mechanism(s) of action and help identify subpopulations for programmatic targeting. The use of non-specialized providers and integration within the primary care environment will guide scale up, while incorporating a cost-effectiveness analysis will aid policy-makers in resource allocation decisions. This study will inform the integration of preventive strategies that target anxiety with existing approaches for treatment of perinatal depression to further the evidence-base for transdiagnostic mental health initiatives globally, and will inform policies to support lifelong maternal mental health and resilience across generations

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. ability to understand spoken Urdu

2. pregnant, =22 weeks' gestation

3. age =18 years

4. residence =20 km of Holy Family Hospital

5. intent to reside in the study areas until the completion of the study

6. score =8 for anxiety on the Hospital Anxiety and Depression Scale (HADS)

Exclusion Criteria:

1. Current major a depressive episode (MDE on SCID) or life-threatening health conditions including e.g. active severe depression or suicidal ideation

2. Self-report of past or current significant learning disability

3. 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)

4. medical disorders or severe maternal morbidity that require inpatient management that would preclude participation (101)

5. ICU admission indicated by diagnosis (not only for assessment)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Birth Weight
• Depression
• Depression, Postpartum
• Postpartum Depression
• Premature Birth
• Preterm Birth
• Small for Gestational Age at Delivery

Intervention

Behavioral:
• Cognitive Behavioral Therapy Intervention for Anxiety
Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.

Locations

Country	Name	City	State
Pakistan	Holy Family Hospital	Rawalpindi

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Human Development Research Foundation, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

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 — View Citation

Atif N, Rauf N, Nazir H, Maryam H, Mumtaz S, Zulfiqar S, Shouket R, Rowther AA, Malik A, Rahman A, Surkan PJ. Non-specialist-delivered psychosocial intervention for prenatal anxiety in a tertiary care setting in Pakistan: a qualitative process evaluation. BMJ Open. 2023 Feb 23;13(2):e069988. doi: 10.1136/bmjopen-2022-069988. — View Citation

Kazi AK, Rowther AA, Atif N, Nazir H, Atiq M, Zulfiqar S, Malik A, Surkan PJ. Intersections between patient-provider communication and antenatal anxiety in a public healthcare setting in Pakistan. PLoS One. 2021 Feb 5;16(2):e0244671. doi: 10.1371/journal.pone.0244671. eCollection 2021. — View Citation

Malik A, Park S, Mumtaz S, Rowther A, Zulfiqar S, Perin J, Zaidi A, Atif N, Rahman A, Surkan PJ. Perceived Social Support and Women's Empowerment and Their Associations with Pregnancy Experiences in Anxious Women: A Study from Urban Pakistan. Matern Child Health J. 2023 May;27(5):916-925. doi: 10.1007/s10995-023-03588-6. Epub 2023 Feb 6. — 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 Nov;30(6):e5885-e5896. doi: 10.1111/hsc.14019. Epub 2022 Sep 19. — 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):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):4926. 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 in Pakistan: design of a randomised trial. BMJ Open. 2020 Apr 15;10(4):e037590. doi: 10.1136/bmjopen-2020-037590. — View Citation

Zaidi A, Khan A, Rowther A, Nazir H, Perin J, Rauf N, Mumtaz S, Naseem H, Atif N, Rahman A, Surkan PJ, Malik A. Cultural adaptation and psychometric validation of the Pregnancy Experience Scale-Brief version (PES-Brief) in Pakistani women with antenatal anxiety symptoms. SSM Ment Health. 2022 Dec;2:100055. doi: 10.1016/j.ssmmh.2021.100055. Epub 2021 Dec 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression).	Data reported is the number of participants with Common Mental Disorders (CMDs), which is defined as a woman having either high anxiety or clinical depression at the time of follow-up. Both CMDs, anxiety was indicated by moderate to severe symptoms on the anxiety portion of the Hospital and Anxiety Scale (HADS). A cutoff of >10 was used as the threshold for moderate to severe levels of anxiety. A Major Depressive Episode (MDE) was measured with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID), which is a semi-structured interview used to make major Axis I Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses. Its scoring will be based on case or non-case basis.	6 weeks postpartum
Secondary	Number of Preterm Births	Number of infants born with <37 weeks' gestation	at birth
Secondary	Small-for-gestational Age Birth	<10th% for gestational age at birth compared to the reference population	at birth
Secondary	Low Birthweight	weight of =2500 grams	at birth