Effectiveness of a guided ACT-based self-help resilience training for depressive symptoms during pregnancy: Study protocol of a randomized controlled trial embedded in a prospective cohort.
Cortisol
Infant development
Peripartum depression
Psychological outcome
Resilience
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
19 Nov 2020
19 Nov 2020
Historique:
received:
05
10
2020
accepted:
04
11
2020
entrez:
20
11
2020
pubmed:
21
11
2020
medline:
15
5
2021
Statut:
epublish
Résumé
During pregnancy, about 10 to 20% of women experience depressive symptoms. Subclinical depression increases the risk of peripartum depression, maternal neuro-endocrine dysregulations, and adverse birth and infant outcomes. Current treatments often comprise face-to-face psychological or pharmacological treatments that may be too intensive for women with subclinical depression leading to drop-out and moderate effectiveness. Therefore, easily accessible, resilience enhancing and less stigmatizing interventions are needed to prevent the development of clinical depression. This paper describes the protocol of a prospective cohort study with an embedded randomized controlled trial (RCT) that aims to improve mental resilience in a sample of pregnant women through a self-help program based on the principles of Acceptance and Commitment Therapy (ACT). Maternal and offspring correlates of the trajectories of peripartum depressive symptoms will also be studied. Pregnant women (≥ 18 years) receiving care in Dutch midwifery practices will participate in a prospective cohort study (n ~ 3500). Between 12 and 18 weeks of pregnancy, all women will be screened for depression with the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS score ≥ 11 will be evaluated with a structured clinical interview. Participants with subclinical depression (n = 290) will be randomized to a 9-week guided self-help ACT-training or to care as usual (CAU). Primary outcomes (depressive symptoms and resilience) and secondary outcomes (e.g. anxiety and PTSD, bonding, infant development) will be collected via online questionnaires at four prospective assessments around 20 weeks and 30 weeks gestation and at 6 weeks and 4 months postpartum. Maternal hair cortisol concentrations will be assessed in a subsample of women with a range of depressive symptoms (n = 300). The intervention's feasibility will be assessed through qualitative interviews in a subsample of participants (n = 20). This is the first study to assess the effectiveness of an easy to administer intervention strategy to prevent adverse mental health effects through enhancing resilience in pregnant women with antepartum depressive symptomatology. This longitudinal study will provide insights into trajectories of peripartum depressive symptoms in relation to resilience, maternal cortisol, psychological outcomes, and infant developmental milestones. Netherlands Trial Register (NTR), NL7499 . Registered 5 February 2019.
Sections du résumé
BACKGROUND
BACKGROUND
During pregnancy, about 10 to 20% of women experience depressive symptoms. Subclinical depression increases the risk of peripartum depression, maternal neuro-endocrine dysregulations, and adverse birth and infant outcomes. Current treatments often comprise face-to-face psychological or pharmacological treatments that may be too intensive for women with subclinical depression leading to drop-out and moderate effectiveness. Therefore, easily accessible, resilience enhancing and less stigmatizing interventions are needed to prevent the development of clinical depression. This paper describes the protocol of a prospective cohort study with an embedded randomized controlled trial (RCT) that aims to improve mental resilience in a sample of pregnant women through a self-help program based on the principles of Acceptance and Commitment Therapy (ACT). Maternal and offspring correlates of the trajectories of peripartum depressive symptoms will also be studied.
METHODS
METHODS
Pregnant women (≥ 18 years) receiving care in Dutch midwifery practices will participate in a prospective cohort study (n ~ 3500). Between 12 and 18 weeks of pregnancy, all women will be screened for depression with the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS score ≥ 11 will be evaluated with a structured clinical interview. Participants with subclinical depression (n = 290) will be randomized to a 9-week guided self-help ACT-training or to care as usual (CAU). Primary outcomes (depressive symptoms and resilience) and secondary outcomes (e.g. anxiety and PTSD, bonding, infant development) will be collected via online questionnaires at four prospective assessments around 20 weeks and 30 weeks gestation and at 6 weeks and 4 months postpartum. Maternal hair cortisol concentrations will be assessed in a subsample of women with a range of depressive symptoms (n = 300). The intervention's feasibility will be assessed through qualitative interviews in a subsample of participants (n = 20).
DISCUSSION
CONCLUSIONS
This is the first study to assess the effectiveness of an easy to administer intervention strategy to prevent adverse mental health effects through enhancing resilience in pregnant women with antepartum depressive symptomatology. This longitudinal study will provide insights into trajectories of peripartum depressive symptoms in relation to resilience, maternal cortisol, psychological outcomes, and infant developmental milestones.
TRIAL REGISTRATION
BACKGROUND
Netherlands Trial Register (NTR), NL7499 . Registered 5 February 2019.
Identifiants
pubmed: 33213400
doi: 10.1186/s12884-020-03395-9
pii: 10.1186/s12884-020-03395-9
pmc: PMC7676420
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
705Subventions
Organisme : ZonMw
ID : 606360098007
Références
BMC Health Serv Res. 2012 Mar 20;12:69
pubmed: 22433820
Psychol Med. 2012 Mar;42(3):485-95
pubmed: 21740624
Br J Clin Psychol. 1992 Sep;31(3):301-6
pubmed: 1393159
Behav Res Ther. 2006 Jan;44(1):1-25
pubmed: 16300724
Int J Psychiatry Med. 1997;27(2):93-105
pubmed: 9565717
Matern Child Health J. 2017 Apr;21(4):915-931
pubmed: 27837388
Qual Life Res. 2009 May;18(4):403-14
pubmed: 19242822
JAMA. 2019 Feb 12;321(6):580-587
pubmed: 30747971
Br J Psychiatry. 2016 Jan;208(1):69-77
pubmed: 26250745
J Neurosci Res. 2020 Jul;98(7):1268-1282
pubmed: 30723972
Trials. 2011 Jun 20;12:157
pubmed: 21689394
Eval Program Plann. 1983;6(3-4):395-400
pubmed: 10267266
J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):245-61
pubmed: 17355398
PLoS One. 2018 Sep 28;13(9):e0204807
pubmed: 30265722
Behav Ther. 2011 Dec;42(4):676-88
pubmed: 22035996
J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
pubmed: 9881538
BMC Pregnancy Childbirth. 2010 Dec 10;10:81
pubmed: 21143961
J Psychosom Res. 2011 Apr;70(4):385-9
pubmed: 21414460
Health Qual Life Outcomes. 2019 Mar 28;17(1):54
pubmed: 30922371
J Obstet Gynecol Neonatal Nurs. 2006 Jul-Aug;35(4):491-8
pubmed: 16881993
BMC Health Serv Res. 2013 Jun 15;13:217
pubmed: 23768141
Eur Child Adolesc Psychiatry. 2011 Jul;20(7):341-50
pubmed: 21523465
Birth Defects Res C Embryo Today. 2012 Dec;96(4):273-88
pubmed: 24203917
Behav Ther. 2012 Dec;43(4):801-11
pubmed: 23046782
Early Hum Dev. 2015 Mar;91(3):217-25
pubmed: 25703316
Clin Psychol Rev. 2015 Nov;41:49-60
pubmed: 24930712
Eur J Psychotraumatol. 2019 Apr 29;10(1):1601990
pubmed: 31069025
Br J Psychiatry. 2020 Apr;216(4):182-188
pubmed: 31806071
J Gen Intern Med. 2016 Oct;31(10):1206-11
pubmed: 27170304
J Affect Disord. 1992 Oct;26(2):105-10
pubmed: 1447427
Med Sci Sports Exerc. 2003 Aug;35(8):1381-95
pubmed: 12900694
Psychoneuroendocrinology. 2015 Oct;60:182-94
pubmed: 26176863
Arch Womens Ment Health. 2015 Feb;18(1):41-60
pubmed: 25422150
Obstet Gynecol Surv. 2017 Sep;72(9):553-568
pubmed: 28905985
Front Neuroendocrinol. 2013 Jan;34(1):27-46
pubmed: 23200813
J Clin Psychol. 2011 Jan;67(1):99-110
pubmed: 20973032
Transl Psychiatry. 2015 Feb 24;5:e515
pubmed: 25710121
Int J Gynaecol Obstet. 2018 Feb;140(2):153-158
pubmed: 29055046
J Pediatr Psychol. 1997 Jun;22(3):313-28
pubmed: 9212550
J Affect Disord. 2018 Mar 15;229:377-385
pubmed: 29331697
Arch Womens Ment Health. 2017 Oct;20(5):645-654
pubmed: 28600645
Br J Psychiatry. 2007 Jul;191:84-5
pubmed: 17602131
Lancet. 2014 Nov 15;384(9956):1800-19
pubmed: 25455250
Early Hum Dev. 2015 Feb;91(2):103-8
pubmed: 25577496
Psychother Psychosom. 2015;84(1):30-6
pubmed: 25547522
Arch Womens Ment Health. 2017 Aug;20(4):539-546
pubmed: 28593361
PLoS One. 2017 Mar 30;12(3):e0173397
pubmed: 28358808
Eval Program Plann. 1982;5(3):233-7
pubmed: 10259963
Tijdschr Psychiatr. 2007;49(6):393-7
pubmed: 17614093
PLoS One. 2016 Sep 01;11(9):e0161804
pubmed: 27584584
BJOG. 2014 Mar;121(4):389-97
pubmed: 24397691
Am J Obstet Gynecol. 2010 Jan;202(1):5-14
pubmed: 20096252
Br J Psychiatry. 1987 Jun;150:782-6
pubmed: 3651732
J Midwifery Womens Health. 2016 Sep;61(5):599-605
pubmed: 27541435
Clin Rheumatol. 2012 Apr;31(4):661-7
pubmed: 22190069
Eur J Obstet Gynecol Reprod Biol. 2014 Mar;174:35-40
pubmed: 24332094
J Anxiety Disord. 1997 Nov-Dec;11(6):587-97
pubmed: 9455721
J Fam Psychol. 2016 Feb;30(1):125-34
pubmed: 26280095
J Affect Disord. 2015 May 15;177:7-21
pubmed: 25743368
J Affect Disord. 2011 May;130(3):385-94
pubmed: 21112641
Arch Womens Ment Health. 2016 Feb;19(1):125-32
pubmed: 25971851
Neurosci Biobehav Rev. 2017 Jul 28;:
pubmed: 28757456
Behav Res Ther. 2011 Jan;49(1):62-7
pubmed: 21074752
Clin Drug Investig. 2004;24(3):157-79
pubmed: 17516702
JAMA Psychiatry. 2016 Mar;73(3):189-90
pubmed: 26815331
J Psychosom Obstet Gynaecol. 2016 Dec;37(4):119-129
pubmed: 27376660
Clin Endocrinol (Oxf). 2015 Aug;83(2):162-6
pubmed: 25823708
J Consult Clin Psychol. 2005 Jun;73(3):539-48
pubmed: 15982151
Eval Program Plann. 1983;6(3-4):299-313
pubmed: 10267258