Postpartum DepressionHMHBNCT03880032
Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention
A study testing Cognitive Behavioral Therapy Intervention for Anxiety in people with Postpartum Depression and Small for Gestational Age at Delivery, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Small for Gestational Age at Delivery, Preterm Birth
- What is being tested?
- Cognitive Behavioral Therapy Intervention for Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Apr 2019to 7 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
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.
Read the 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
- Being tested
- Cognitive Behavioral Therapy Intervention for Anxiety
- Keywords
- anxiety, depression, birth outcomes
- Medical subject headings
- Depression, Postpartum, Premature Birth, Anxiety Disorders, Birth Weight, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy Intervention for AnxietyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks postpartum
Secondary outcomes (3)
Number of Preterm Births
Number of infants born with <37 weeks' gestation
Measured: at birth
Small-for-gestational Age Birth
<10th% for gestational age at birth compared to the reference population
Measured: at birth
Low Birthweight
weight of ≤2500 grams
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start16 Apr 2019
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Human Development Research Foundation, Pakistan
- Responsible party
- Sponsor
- Investigators
- Pamela J. Surkan, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880032
- Sponsor's protocol ID
- R01MH111859-01
- Acronym
- HMHB
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2019
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified project data from the study will be posted on ClinicalTrials.gov and the National Institute of Mental Health (NIMH) data archive.
Publications
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.
PubMed 32300002Rowther 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.
PubMed 32650551Rauf 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.
PubMed 34443987Kazi 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.
PubMed 33544747Nazir 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.
PubMed 36121172Zaidi 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.
PubMed 36969715Atif 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.
PubMed 36822801Malik 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.
PubMed 36746839Atif 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.
PubMed 31998151Khanna D, Toscano M, Park S, Rahman A, Atif N, Osborne LM, Malik A, Surkan PJ. Maternal Responsiveness, Parenting Self-efficacy, and Economic Empowerment: Determinants of Infant Development in Pakistan. J Dev Behav Pediatr. 2026 Apr 15:10.1097/DBP.0000000000001481. doi: 10.1097/DBP.0000000000001481. Online ahead of print.
PubMed 41984574Siebach 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.
PubMed 39740193Surkan 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.
PubMed 39097000Nisar 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.
PubMed 39095863Siebach 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.
PubMed 38877077Sun 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.
PubMed 38440406
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
- ClinicalTrials.gov ID
- NCT03880032
- Acronym / sponsor ID
- HMHB / R01MH111859-01
- Conditions
- Postpartum Depression, Small for Gestational Age at Delivery, Preterm Birth, Anxiety, Birth Weight
- Keywords
- anxiety, depression, birth outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Human Development Research Foundation, Pakistan
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 15 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy Intervention for Anxiety | Experimental | Behavioral: Cognitive Behavioral Therapy Intervention for AnxietyPregnant 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy Intervention for AnxietyHappy 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. | Behavioural | Cognitive Behavioral Therapy Intervention for Anxiety |
Primary outcome
Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression).
Time frame: 6 weeks postpartum
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.
3 secondary outcomes
Number of Preterm Births
Time frame: at birth
Small-for-gestational Age Birth
Time frame: at birth
Low Birthweight
Time frame: at birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32300002Surkan 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.
- Background: PubMed 32650551Rowther 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.
- Background: PubMed 34443987Rauf 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.
- Background: PubMed 33544747Kazi 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.
- Background: PubMed 36121172Nazir 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.
- Background: PubMed 36969715Zaidi 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.
- Background: PubMed 36822801Atif 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.
- Background: PubMed 36746839Malik 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.
- Results publication: PubMed 31998151Atif 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.
- Derived from this study: PubMed 41984574Khanna D, Toscano M, Park S, Rahman A, Atif N, Osborne LM, Malik A, Surkan PJ. Maternal Responsiveness, Parenting Self-efficacy, and Economic Empowerment: Determinants of Infant Development in Pakistan. J Dev Behav Pediatr. 2026 Apr 15:10.1097/DBP.0000000000001481. doi: 10.1097/DBP.0000000000001481. Online ahead of print.
- Derived from this study: PubMed 39740193Siebach 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.
- Derived from this study: PubMed 39097000Surkan 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.
- Individual participant dataSharing planned: Yes. De-identified project data from the study will be posted on ClinicalTrials.gov and the National Institute of Mental Health (NIMH) data archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela J. Surkan, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy Intervention for Anxiety in people with Postpartum Depression and Small for Gestational Age at Delivery, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880032, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.