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

NCT03880032 | Completed Results DMC

• 1 other identifier: R01MH111859-01
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

anxiety; depression; birth outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Preterm Births

  at birth

• Small-for-gestational Age Birth

  at birth

• Low Birthweight

  at birth

Study Arms (2)

Cognitive Behavioral Therapy Intervention for Anxiety

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy Intervention for Anxiety

Enhanced Usual Care

NO INTERVENTION

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).

Interventions

Cognitive Behavioral Therapy Intervention for Anxiety 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.

Cognitive Behavioral Therapy Intervention for Anxiety

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• 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
• score ≥8 for anxiety on the Hospital Anxiety and Depression Scale (HADS)

You may not qualify if:

• Current major a 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

Study Sites (1)

Holy Family Hospital

Rawalpindi, Pakistan

Location

Related Publications (17)

• 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 BACKGROUND

• 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.

  PMID: 32650551 BACKGROUND

• 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.

  PMID: 34443987 BACKGROUND

• 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.

  PMID: 33544747 BACKGROUND

• 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.

  PMID: 36121172 BACKGROUND

• 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.

  PMID: 36969715 BACKGROUND

• 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.

  PMID: 36822801 BACKGROUND

• 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.

  PMID: 36746839 BACKGROUND

• 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 RESULT

• 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.

  PMID: 39740193 DERIVED

• 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.

  PMID: 39097000 DERIVED

• 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.

  PMID: 39095863 DERIVED

• 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.

  PMID: 38877077 DERIVED

• 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.

  PMID: 38440406 DERIVED

• 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.

  PMID: 38365951 DERIVED

• 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 DERIVED

• 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.

  PMID: 34286512 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Premature Birth; Anxiety Disorders; Birth Weight; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Limitations and Caveats

The Covid-19 pandemic occurred in the middle of data collection for this study. Because of the lockdowns data collection was halted for a period and also slowed. It probably also contributed to loss to follow up as many women were fearful of coming to the hospital.

Results Point of Contact

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

psurkan@jhu.edu

4105027396

Study Officials

• Pamela J. Surkan, PhD

  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: To maintain masking during the trial, intervention and assessment teams will not have any interaction during the trial, as they will be placed at separate locations within the Obstetrics Department of Holy Family Hospital (HFH). Furthermore, participants will be instructed not to disclose which type of treatment they are receiving to the assessment team. Fidelity of masking will be measured by having assessors guess the trial arm of each participant at the end of follow-up assessment. We hypothesize that assessors will only be able to correctly guess the condition of participants at a chance rate of nearly 50% at follow-up assessments, indicating that masking is maintained.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women with at least mild anxiety but not depression will be enrolled simultaneously into an intervention or an enhanced usual care group during pregnancy. Women in the intervention group will receive individual-based cognitive behavioral therapy. Women in the control group with receive enhanced usual care.

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 19, 2019
• Study Start: April 16, 2019
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol and statistical analysis plan (SAP) have been shared in the study protocol paper published in BMJ Open (PMID: 32300002; PMCID: PMC7200036). The Informed Consent Forms (ICF) have been published accessed and as the Supplementary Material associated with that article.
• Access Criteria: There is a link to the Informed Consent Forms (ICF) on the open access website for our protocol paper. Please see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7200036/

Locations

PA (1)