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

NCT ID: NCT03880032

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2022-10-07

Brief 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.

Detailed 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

Conditions

Postpartum Depression; Small for Gestational Age at Delivery; Preterm Birth; Anxiety; Birth Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cognitive Behavioral Therapy Intervention for Anxiety

Pregnant women experiencing anxiety randomized to the Happy Mother Healthy Baby (HMHB) intervention receive a CBT-based psychosocial intervention (with six core and up to six booster sessions). HMHB is a facility-based intervention delivered by non-specialist providers. It is aimed to raise psychosocial awareness and facilitate positive change inter personal wellbeing, social support, and bonding with their baby during pregnancy. It addresses with relapse prevention, planning for the baby's arrival, and in management of emotional challenges in the early postnatal period. Family member/s will be invited to attend 3 core sessions.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy Intervention for Anxiety

Intervention Type: BEHAVIORAL

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.

Enhanced Usual Care

Women randomized to the control group will receive enhanced usual care (EUC). The World Health Organization (WHO) recommends 8 antenatal visits for a positive pregnancy experience, the number of visits our EUC control group participants will receive (depending on their gestational week). Usual care will also be enhanced by hospital staff receiving additional training in mental health treatment and counseling. 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 intervention group).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Human Development Research Foundation, Pakistan

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela J. Surkan, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Holy Family Hospital

Rawalpindi, , Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 32300002 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32650551 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34443987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33544747 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36121172 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36969715 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36822801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36746839 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31998151 (View on PubMed)

Siebach KF, Park S, Mansoor M, Atif N, Zaidi A, Rahman A, Malik A, Surkan PJ. The Association of Spousal Relationship Quality and Social Support With Maternal-Infant Bonding: Moderating Roles of Maternal Age and Paternal Occupation. Infancy. 2025 Jan-Feb;30(1):e12647. doi: 10.1111/infa.12647.

Reference Type: DERIVED

PMID: 39740193 (View on PubMed)

Surkan PJ, Park S, Sheng Z, Zaidi A, Atif N, Osborne LM, Rahman A, Malik A. Effects of a Prenatal Anxiety Randomized Controlled Trial Intervention on Infant Development in Pakistan. Acad Pediatr. 2025 Jan-Feb;25(1):102551. doi: 10.1016/j.acap.2024.07.018. Epub 2024 Aug 2.

Reference Type: DERIVED

PMID: 39097000 (View on PubMed)

Nisar A, Xiang H, Perin J, Malik A, Zaidi A, Atif N, Rahman A, Surkan PJ. Impact of an intervention for perinatal anxiety on breastfeeding: findings from the Happy Mother-Healthy Baby randomized controlled trial in Pakistan. Int Breastfeed J. 2024 Aug 2;19(1):53. doi: 10.1186/s13006-024-00655-8.

Reference Type: DERIVED

PMID: 39095863 (View on PubMed)

Siebach KF, Perin J, Malik A, Atif N, Zaidi A, Rahman A, Surkan PJ. Results of a cognitive behavior therapy-based intervention for antenatal anxiety on birth outcomes in Pakistan: a randomized control trial. Sci Rep. 2024 Jun 14;14(1):13806. doi: 10.1038/s41598-024-64119-z.

Reference Type: DERIVED

PMID: 38877077 (View on PubMed)

Sun Y, Park S, Malik A, Atif N, Zaidi A, Rahman A, Surkan PJ. Pregnancy stressors and postpartum symptoms of depression and anxiety: the moderating role of a cognitive-behavioural therapy (CBT) intervention. Gen Psychiatr. 2024 Feb 28;37(1):e101136. doi: 10.1136/gpsych-2023-101136. eCollection 2024.

Reference Type: DERIVED

PMID: 38440406 (View on PubMed)

Surkan PJ, Malik A, Perin J, Atif N, Rowther A, Zaidi A, Rahman A. Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial. Nat Med. 2024 Mar;30(3):675-682. doi: 10.1038/s41591-024-02809-x. Epub 2024 Feb 16.

Reference Type: DERIVED

PMID: 38365951 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37040167 (View on PubMed)

Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.

Reference Type: DERIVED

PMID: 34286512 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH111859-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link