Clinical trial NCT03536442: Promoting Attachment Through Healing
Official title: Examining the Impact of Trauma-informed Cognitive Behavioural Therapy Among At-risk Pregnant Women on Perinatal Mental Health Outcomes: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Disorders, Post-Traumatic
Depressive Disorder
Anxiety Disorders
Keywords: antenatal
postpartum
mental health
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2018-05-24
Enrollment: 3
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women will be recruited from the perinatal clinic at London Health Sciences (LHSC), London, Ontario, Canada. London, Ontario is an urban setting with a population of approximately 350,000. LHSC is one of Canada's largest acute-care teaching hospitals.

Brief summary: Intimate partner violence (IPV) is a significant and pervasive public health challenge and is associated with mental illnesses such as depression, anxiety and posttraumatic stress disorder (PTSD). Although the perinatal period may be a time of greater risk for experiencing IPV, and greater vulnerability to PTSD symptomatology, a lack of research exists pertaining to the identification/treatment of IPV-related PTSD symptoms during this period. Utilizing a mixed-methods approach, and employing a feminist, intersectional framework, the effectiveness of trauma-informed cognitive behavioural therapy (CBT) among pregnant survivors of IPV experiencing PTSD symptomatology on depression, anxiety, PTSD and maternal-infant attachment will be explored.

Detailed description: IPV is a pervasive public health problem \[1\], with estimates of approximately 50% of Canadian women experiencing IPV at least once during their lifetime \[2\]. Some studies suggest that the perinatal period is a time of higher risk for experiencing IPV \[3-4\]. Numerous studies have linked women's experience of IPV with mental health concerns such as depression, anxiety and PTSD \[5-8\] and rates of PTSD are higher for perinatal women compared to the general population \[9-10\]. Prevalence rates of PTSD among survivors of IPV range from 31-84% \[7,11\].

The perinatal period may relate to greater risk for re-triggering of PTSD, given the physical/emotional changes, and the intimate/invasive nature of perinatal care. Additionally, the medicalized processes involved may contribute to feelings of powerlessness and vulnerability, further compromising at-risk women \[9\]. PTSD can alter psychological functioning and is associated with depression \[12\], disordered eating, substance abuse, sexual risk exposures and re-victimization \[13\] and failure to engage in health promotion strategies such as exercise, diet and routine health care \[14\]; all of which may exacerbate obstetrical risk. Furthermore, mental illness and trauma have been associated with infant prematurity, low birth weight and childhood developmental delays \[15\] in addition to adverse effects on maternal functioning such as maternal-child attachment \[15\]. As such, there are enormous personal and societal costs associated with PTSD related to IPV for childbearing women.

Recently, a significant gap in the literature was identified pertaining to the identification and treatment of IPV-related PTSD of childbearing women \[16\]. There is a critical need for individualized, trauma-informed care to facilitate optimal maternal and child attachment outcomes \[16\]. Fortunately, effective PTSD treatments exist, such as CBT; however, research exploring CBT in pregnant populations is lacking \[17\]. As such, the purpose of this study is to explore the effectiveness of CBT for the treatment of IPV-related PTSD among antenatal women.

Eligibility criteria: Inclusion Criteria:

Women who received antenatal CBT treatment from the Perinatal Nurse Specialist at the Perinatal Mental Health Clinic (London Health Sciences Centre, London, ON, Canada) who are:

* English speaking
* Have symptoms consistent with PTSD, depression, and/or anxiety

Exclusion Criteria:

* Women will be excluded if there is, or if it anticipated that there will be involvement in child protection services under the Child and Family Services Act

Primary outcomes:
measure: PTSD
timeFrame: Up to 52 weeks postpartum
Secondary outcomes:
measure: Maternal-infant attachment
timeFrame: Up to 52 weeks postpartum
measure: Presence of postpartum depression
timeFrame: Up to 52 weeks postpartum
measure: Anxiety
timeFrame: Up to 52 weeks postpartum
Other outcomes:
measure: Maternal quality of life
timeFrame: Up to 52 weeks postpartum
measure: Maternal coping
timeFrame: Up to 52 weeks postpartum
Locations:
city: London
country: Canada
facility: London Health Sciences
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Kimberley T Jackson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: World Health Organization. World report on violence and health. Geneva: World Health Organization; 2002
citation: Garcia-Moreno C, Jansen HA, Ellsberg M, Heise L, Watts CH; WHO Multi-country Study on Women's Health and Domestic Violence against Women Study Team. Prevalence of intimate partner violence: findings from the WHO multi-country study on women's health and domestic violence. Lancet. 2006 Oct 7;368(9543):1260-9. doi: 10.1016/S0140-6736(06)69523-8.
citation: Campbell JC. Health consequences of intimate partner violence. Lancet. 2002 Apr 13;359(9314):1331-6. doi: 10.1016/S0140-6736(02)08336-8.
citation: Afifi TO, MacMillan H, Cox BJ, Asmundson GJ, Stein MB, Sareen J. Mental health correlates of intimate partner violence in marital relationships in a nationally representative sample of males and females. J Interpers Violence. 2009 Aug;24(8):1398-417. doi: 10.1177/0886260508322192. Epub 2008 Aug 15.
citation: Coker AL, Smith PH, Thompson MP, McKeown RE, Bethea L, Davis KE. Social support protects against the negative effects of partner violence on mental health. J Womens Health Gend Based Med. 2002 Jun;11(5):465-76. doi: 10.1089/15246090260137644.
citation: Golding JM. Intimate partner violence as a risk factor for mental disorders: A meta-analysis. J Fam Violence. 1999;6:81-95.
citation: Plichta SB. Intimate partner violence and physical health consequences: policy and practice implications. J Interpers Violence. 2004 Nov;19(11):1296-323. doi: 10.1177/0886260504269685.
citation: Seng JS, Rauch SA, Resnick H, Reed CD, King A, Low LK, McPherson M, Muzik M, Abelson J, Liberzon I. Exploring posttraumatic stress disorder symptom profile among pregnant women. J Psychosom Obstet Gynaecol. 2010 Sep;31(3):176-87. doi: 10.3109/0167482X.2010.486453.
citation: Seng JS, Sperlich M, Low LK. Mental health, demographic, and risk behavior profiles of pregnant survivors of childhood and adult abuse. J Midwifery Womens Health. 2008 Nov-Dec;53(6):511-21. doi: 10.1016/j.jmwh.2008.04.013.
citation: Jones L, Hughes M, Unterstaller U. Post-traumatic stress disorder (PTSD) in victims of domestic violence. Trauma, Violence, Abuse. 2001;2(2):99-119
citation: Breslau N, Davis GC, Peterson EL, Schultz LR. A second look at comorbidity in victims of trauma: the posttraumatic stress disorder-major depression connection. Biol Psychiatry. 2000 Nov 1;48(9):902-9. doi: 10.1016/s0006-3223(00)00933-1.
citation: Ahluwalia IB, Merritt R, Beck LF, Rogers M. Multiple lifestyle and psychosocial risks and delivery of small for gestational age infants. Obstet Gynecol. 2001 May;97(5 Pt 1):649-56. doi: 10.1016/s0029-7844(01)01324-2.
citation: Rheingold A, Acierno R, Resnick H. Trauma, posttraumatic stress disorder, and health risk behaviors. 2004 [cited 2016 Sep 14]; Available from: http://psycnet.apa.org/psycinfo/2003-88426-009
citation: Lee King PA, Duan L, Amaro H. Clinical needs of in-treatment pregnant women with co-occurring disorders: implications for primary care. Matern Child Health J. 2015 Jan;19(1):180-7. doi: 10.1007/s10995-014-1508-x.
citation: Jackson K, Mantler T. Examining the Impact of Posttraumatic Stress Disorder Related to Intimate Partner Violence on Antenatal, Intrapartum and Postpartum Women: A Scoping Review. J Fam Violence [Internet]. 2016
citation: Lapp LK, Agbokou C, Peretti CS, Ferreri F. Management of post traumatic stress disorder after childbirth: a review. J Psychosom Obstet Gynaecol. 2010 Sep;31(3):113-22. doi: 10.3109/0167482X.2010.503330.
citation: McFarlane J, Parker B, Soeken K, Bullock L. Assessing for abuse during pregnancy. Severity and frequency of injuries and associated entry into prenatal care. JAMA. 1992 Jun 17;267(23):3176-8. doi: 10.1001/jama.267.23.3176.
citation: Jackson KT, Parkinson S, Jackson B, Mantler T. Examining the Impact of Trauma-Informed Cognitive Behavioral Therapy on Perinatal Mental Health Outcomes Among Survivors of Intimate Partner Violence (The PATH Study): Protocol for a Feasibility Study. JMIR Res Protoc. 2018 May 25;7(5):e134. doi: 10.2196/resprot.9820.