Abstract
Anxiety experienced by women during pregnancy is highly prevalent, especially in resource-poor settings and strongly predicts postnatal common mental disorders (CMDs), anxiety and depression. We evaluated the effectiveness of an anxiety-focused early prenatal intervention on preventing postnatal CMDs. This study was a phase 3, two-arm, single-blind, randomized controlled trial conducted in Pakistan with women who were ≤22 weeks pregnant and had at least mild anxiety without clinical depression. Participants were randomized to the Happy Mother–Healthy Baby program, based on cognitive behavioral therapy, consisting of six one-on-one intervention sessions in pregnancy delivered by non-specialist providers, or to enhanced care alone. The primary outcome was major depression, generalized anxiety disorder or both at 6 weeks after delivery. Overall, 755 women completed postnatal assessments (380 (50.3%), intervention arm; 375 (49.7%) enhanced-care arm). The primary outcomes were met. Examined jointly, we found 81% reduced odds of having either a major depressive episode (MDE) or moderate-to-severe anxiety for women randomized to the intervention (adjusted odds ratio (aOR) = 0.19, 95% CI 0.14–0.28). Overall, 12% of women in the intervention group developed MDE at 6 weeks postpartum, versus 41% in the control group. We found reductions of 81% and 74% in the odds of postnatal MDE (aOR = 0.19, 95% CI 0.13–0.28) and of moderate-to-severe anxiety (aOR = 0.26, 95% CI 0.17–0.40), respectively. The Happy Mother–Healthy Baby program early prenatal intervention focusing on anxiety symptoms reduced postpartum CMDs. ClinicalTrials.gov identifier NCT03880032.
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References
Fisher, J. et al. Prevalence and determinants of common perinatal mental disorders in women in low- and lower-middle-income countries: a systematic review. Bull. World Health Organ. 90, 139G–149G (2012).
Nielsen-Scott, M., Fellmeth, G., Opondo, C. & Alderdice, F. Prevalence of perinatal anxiety in low- and middle-income countries: a systematic review and meta-analysis. J. Affect. Disord. 306, 71–79 (2022).
Jacob, K. S. et al. Mental health systems in countries: where are we now? Lancet 370, 1061–1077 (2007).
Coelho, H. F., Murray, L., Royal-Lawson, M. & Cooper, P. J. Antenatal anxiety disorder as a predictor of postnatal depression: a longitudinal study. J. Affect. Disord. 129, 348–353 (2011).
Grigoriadis, S. et al. A systematic review and meta-analysis of the effects of antenatal anxiety on postpartum outcomes. Arch. Womens Ment. Health 22, 543–556 (2019).
Enătescu, I. et al. The role of personality dimensions and trait anxiety in increasing the likelihood of suicide ideation in women during the perinatal period. J. Psychosom. Obstet. Gynaecol. 42, 242–252 (2021).
Kessler, R. C. et al. Anxious and non-anxious major depressive disorder in the World Health Organization world mental health surveys. Epidemiol. Psychiatr. Sci. 24, 210–226 (2015).
Premji, S. S. et al. Comorbid anxiety and depression among pregnant Pakistani women: higher rates, different vulnerability characteristics, and the role of perceived stress. Int. J. Environ. Res. Public Health 17, 7295 (2020).
Talge, N. M., Neal, C., Glover, V. & Early Stress, Translational Research and Prevention Science Network: Fetal and Neonatal Experience on Child and Adolescent Mental Health. Antenatal maternal stress and long-term effects on child neurodevelopment: how and why? J. Child Psychol. Psychiatry 48, 245–261 (2007).
Tarabulsy, G. M. et al. Meta-analytic findings of the relation between maternal prenatal stress and anxiety and child cognitive outcome. J. Dev. Behav. Pediatr. 35, 38–43 (2014).
Niaz, S., Izhar, N. & Bhatti, M. R. Anxiety and depression in pregnant women presenting in the OPD of a teaching hospital. Pak. J. Med. Sci. 20, 117–119 (2004).
Waqas, A. et al. Psychosocial factors of antenatal anxiety and depression in Pakistan: is social support a mediator? PLoS ONE 10, e0116510 (2015).
Khanlari, S., Barnett, Am,B., Ogbo, F. A. & Eastwood, J. Re-examination of perinatal mental health policy frameworks for women signalling distress on the Edinburgh Postnatal Depression Scale (EPDS) completed during their antenatal booking-in consultation: a call for population health intervention. BMC Pregnancy Childbirth 19, 221 (2019).
Dadi, A. F., Miller, E. R. & Mwanri, L. Postnatal depression and its association with adverse infant health outcomes in low- and middle-income countries: a systematic review and meta-analysis. BMC Pregnancy Childbirth 20, 416 (2020).
Ali, N. S., Mahmud, S., Khan, A. & Ali, B. S. Impact of postpartum anxiety and depression on child’s mental development from two peri-urban communities of Karachi, Pakistan: a quasi-experimental study. BMC Psychiatry 13, 274 (2013).
Green, S. M., Haber, E., Frey, B. N. & McCabe, R. E. Cognitive-behavioral group treatment for perinatal anxiety: a pilot study. Arch. Womens Ment. Health 18, 631–638 (2015).
Misri, S., Abizadeh, J., Sanders, S. & Swift, E. Perinatal generalized anxiety disorder: assessment and treatment. J. Womens Health 24, 762–770 (2015).
Rahman, A., Malik, A., Sikander, S., Roberts, C. & Creed, F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet 372, 902–909 (2008).
Saxena, S., Thornicroft, G., Knapp, M. & Whiteford, H. Resources for mental health: scarcity, inequity, and inefficiency. Lancet 370, 878–889 (2007).
Demyttenaere, K. et al. Prevalence, severity, and unmet need for treatment of mental disorders in the World Health Organization world mental health surveys. JAMA 291, 2581–2590 (2004).
Patel, V. et al. Reducing the treatment gap for mental disorders: a WPA survey. World Psychiatry 9, 169–176 (2010).
Atif, N. et al. Development of a psychological intervention to address anxiety during pregnancy in a low-income country. Front. Psychiatry 10, 927 (2019).
Kazi, A. K. et al. Intersections between patient–provider communication and antenatal anxiety in a public healthcare setting in Pakistan. PLoS ONE 16, e0244671 (2021).
Rowther, A. A. et al. ‘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 17, E4926 (2020).
Nazir, H. et al. ‘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 30, e5885–e5896 (2022).
Zimet, G. D., Dahlem, N. W., Zimet, S. G. & Farley, G. K. The multidimensional scale of perceived social support. J. Pers. Assess. 52, 30–41 (1988).
Kroenke, K. Enhancing the clinical utility of depression screening. CMAJ 184, 281–282 (2012).
Li, X. et al. Effectiveness of cognitive behavioral therapy for perinatal maternal depression, anxiety and stress: a systematic review and meta-analysis of randomized controlled trials. Clin. Psychol. Rev. 92, 102129 (2022).
Cho, H. J., Kwon, J. H. & Lee, J. J. Antenatal cognitive-behavioral therapy for prevention of postpartum depression: a pilot study. Yonsei Med. J. 49, 553–562 (2008).
Milgrom, J., Schembri, C., Ericksen, J., Ross, J. & Gemmill, A. W. Towards parenthood: an antenatal intervention to reduce depression, anxiety and parenting difficulties. J. Affect. Disord. 130, 385–394 (2011).
Waqas, A. et al. Prevention of common mental disorders among women in the perinatal period: a critical mixed-methods review and meta-analysis. Global Mental Health https://doi.org/10.1017/gmh.2022.17 (2022).
Ponting, C., Chavira, D. A., Dunkel Schetter, C. & Urizar, G. G. Cognitive behavioral stress management effects on prenatal anxiety among low-income women. J. Consult. Clin. Psychol. 90, 148–160 (2022).
Bittner, A. et al. Early intervention in pregnant women with elevated anxiety and depressive symptoms: efficacy of a cognitive-behavioral group program. J. Perinat. Neonatal Nurs. 28, 185–195 (2014).
Fathi-Ashtiani, A., Ahmadi, A., Ghobari-Bonab, B., Azizi, M. P. & Saheb-Alzamani, S. M. Randomized trial of psychological interventions to preventing postpartum depression among iranian first-time mothers. Int. J. Prev. Med. 6, 109 (2015).
Sanaati, F., Charandabi, S. M.-A., Eslamlo, H. F. & Mirghafourvand, M. A randomized controlled trial on the effect of lifestyle education for Iranian women and their husbands on post-partum anxiety and depression. Health Educ. Res. 33, 416–428 (2018).
Moshki, M., Baloochi Beydokhti, T. & Cheravi, K. The effect of educational intervention on prevention of postpartum depression: an application of health locus of control. J. Clin. Nurs. 23, 2256–2263 (2014).
Qin, X., Liu, C., Zhu, W., Chen, Y. & Wang, Y. Preventing postpartum depression in the early postpartum period using an app-based cognitive behavioral therapy program: a pilot randomized controlled study. Int. J. Environ. Res. Public Health 19, 16824 (2022).
Sun, M. et al. A study protocol of mobile phone app-based cognitive behaviour training for the prevention of postpartum depression among high-risk mothers. BMC Public Health 19, 710 (2019).
Simhi, M., Sarid, O., Rowe, H., Fisher, J. & Cwikel, J. A cognitive-behavioral intervention for postpartum anxiety and depression: individual phone vs. group format. J. Clin. Med. 10, 5952 (2021).
Guo, L., Zhang, J., Mu, L. & Ye, Z. Preventing postpartum depression with mindful self-compassion intervention: a randomized control study. J. Nerv. Ment. Dis. 208, 101–107 (2020).
Rauf, N. et al. 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 18, 8237 (2021).
Atif, N. et al. Non-specialist-delivered psychosocial intervention for prenatal anxiety in a tertiary care setting in Pakistan: a qualitative process evaluation. BMJ Open 13, e069988 (2023).
Patel, V. Rethinking mental health care: bridging the credibility gap. Intervention 12, 15 (2014).
McAllister-Williams, R. H. et al. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J. Psychopharmacol. 31, 519–552 (2017).
MacQueen, G. M. et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 clinical guidelines for the management of adults with major depressive disorder: section 6. special populations: youth, women, and the elderly. Can. J. Psychiatry 61, 588–603 (2016).
Desjarlais, R. World Mental Health: Problems and Priorities in Low-income Countries (Oxford University Press, 1995).
Kabeer, N. The Conditions and Consequences of Choice: Reflections on the Measurement of Women’s Empowerment (UNRISD, 1999).
Kabeer, N. Resources, agency, achievements: reflections on the measurement of women’s empowerment. Dev. Change 30, 435–464 (1999).
Kabeer, N. The Power to Choose: Bangladeshi Women and Labour Market Decisions in London and Dhaka (Verso, 2000).
Kabeer, N. Women’s empowerment and the question of choice. J. Int. Aff. 72, 209–214 (2019).
Kohrt, B. A. et al. Therapist competence in global mental health: development of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale. Behav. Res. Ther. 69, 11–21 (2015).
Murray, L. K. et al. A common elements treatment approach for adult mental health problems in low- and middle-income countries. Cogn. Behav. Pract. 21, 111–123 (2014).
Zigmond, A. S. & Snaith, R. P. The hospital anxiety and depression scale. Acta Psychiatr. Scand. 67, 361–370 (1983).
Mumford, D. B., Tareen, I. A. K., Bajwa, M. A. Z., Bhatti, M. R. & Karim, R. The translation and evaluation of an Urdu version of the Hospital Anxiety and Depression Scale. Acta Psychiatr. Scand. 83, 81–85 (1991).
Ali, N. S., Azam, I. S., Ali, B. S., Tabbusum, G. & Moin, S. S. Frequency and associated factors for anxiety and depression in pregnant women: a hospital-based cross-sectional study. ScientificWorldJournal 2012, 653098 (2012).
Karmaliani, R. et al. Prevalence of anxiety, depression and associated factors among pregnant women of Hyderabad, Pakistan. Int. J. Soc. Psychiatry 55, 414–424 (2009).
Patel, V. et al. Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial. Lancet 376, 2086–2095 (2010).
Rahman, A. et al. Interventions for common perinatal mental disorders in women in low- and middle-income countries: a systematic review and meta-analysis. Bull. World Health Organ. 91, 593–601I (2013).
Surkan, P. J. et al. 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 10, e037590 (2020).
Rahman, A., Iqbal, Z., Waheed, W. & Hussain, N. Translation and cultural adaptation of health questionnaires. J. Pak. Med. Assoc. 53, 142–147 (2003).
Rahman, A. et al. The impact of perinatal depression on exclusive breastfeeding: a cohort study. Matern. Child Nutr. 12, 452–462 (2016).
Rahman, A. et al. Young, single and not depressed: prevalence of depressive disorder among young women in rural Pakistan. J. Affect. Disord. 117, 42–47 (2009).
Maselko, J. et al. Child mental health and maternal depression history in Pakistan. Soc. Psychiatry Psychiatr. Epidemiol. 51, 49–62 (2016).
Maselko, J. et al. Effect of an early perinatal depression intervention on long-term child development outcomes: follow-up of the Thinking Healthy Programme randomised controlled trial. Lancet Psychiatry 2, 609–617 (2015).
Turner, E. L. et al. The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for a three-year cluster randomized controlled trial. Trials 17, 442 (2016).
Dodani, S. & Zuberi, R. Center-based prevalence of anxiety and depression in women of the northern areas of Pakistan. J. Pak. Med. Assoc. 50, 138–140 (2000).
Qadir, F., Khalid, A., Haqqani, S., Zill-e-Huma & Medhin, G. The association of marital relationship and perceived social support with mental health of women in Pakistan. BMC Public Health 13, 1150 (2013).
Kroenke, K., Spitzer, R. L. & Williams, J. B. The PHQ-9: validity of a brief depression severity measure. J. Gen. Intern. Med. 16, 606–613 (2001).
Aziz, K., Sadaf, B. & Kanwal, S. Psychosocial problems of Pakistani parents of thalassemic children: a cross sectional study done in Bahawalpur, Pakistan. Biopsychosoc. Med. 6, 15 (2012).
Altaf, A. et al. Sociodemographic pattern of depression in urban settlement of Karachi, Pakistan. J. Clin. Diagn. Res 9, VC09–VC13 (2015).
Husain, N., Gater, R., Tomenson, B. & Creed, F. Comparison of the personal health questionnaire and the self reporting questionnaire in rural Pakistan. J. Pak. Med. Assoc. 56, 366–370 (2006).
Ahmer, S., Faruqui, R. A. & Aijaz, A. Psychiatric rating scales in Urdu: a systematic review. BMC Psychiatry 7, 59 (2007).
Acknowledgements
We extend our heartfelt gratitude to the study participants and obstetric staff at the Department of Obstetrics and Gynaecology at Rawalpindi Medical University. Additionally, we are deeply indebted to M. Umar, R. Chaudhri and A. Tamizuddin Nizami of Rawalpindi Medical University for their unwavering support, both administrative and clinical, spanning the entire trajectory of our research from inception to completion. This study was supported by the NIMH at the US National Institutes of Health (grant no. RO1 MH111859, to P.J.S.). The NIMH had no role in the conduct of this research.
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P.J.S. conceptualized the study, drafted the original manuscript, contributed to the interpretation of results and was the study’s principal investigator. A.M. supervised the implementation of the study including data collection and all field activities, reviewed the manuscript and contributed to the interpretation of the results. J.P. performed the statistical analysis, drafted the results, reviewed the manuscript and contributed to the interpretation of the results. N.A. led the development of the HMHB intervention, supervised its delivery, reviewed the manuscript and contributed to the interpretation of the results. A. Rowther contributed to the writing and editing of the manuscript. A.Z. managed the data, cleaned and curated the data and constructed the flow chart. A. Rahman conceptualized the study, assisted in supervision of the team, edited the manuscript and contributed to the interpretation of the results. All authors approved the final manuscript.
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Surkan, P.J., Malik, A., Perin, J. et al. Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial. Nat Med 30, 675–682 (2024). https://doi.org/10.1038/s41591-024-02809-x
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DOI: https://doi.org/10.1038/s41591-024-02809-x
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