Promoting Attachment Through Healing

Anxiety Disorders Clinical Trial

— PATH  

Official title:

Examining the Impact of Trauma-informed Cognitive Behavioural Therapy Among At-risk Pregnant Women on Perinatal Mental Health Outcomes: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536442
• Other study ID #: 10016616
• Secondary ID: R5498A03
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: May 2019
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Disease
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
Canada	London Health Sciences	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (17)

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. — View 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. — View 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. — View Citation

Campbell JC. Health consequences of intimate partner violence. Lancet. 2002 Apr 13;359(9314):1331-6. Review. — View 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. — View 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. — View Citation

Golding JM. Intimate partner violence as a risk factor for mental disorders: A meta-analysis. J Fam Violence. 1999;6:81-95.

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

Jones L, Hughes M, Unterstaller U. Post-traumatic stress disorder (PTSD) in victims of domestic violence. Trauma, Violence, Abuse. 2001;2(2):99-119

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. Review. — View 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. — View 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. — View Citation

Plichta SB. Intimate partner violence and physical health consequences: policy and practice implications. J Interpers Violence. 2004 Nov;19(11):1296-323. Review. — View 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

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. — View 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. — View Citation

World Health Organization. World report on violence and health. Geneva: World Health Organization; 2002

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal quality of life	Maternal quality of life will be measured using the World Health Organization Quality of Life - Brief questionnaire (WHOQOL-BREF). Higher scores denote higher quality of life. We are not using a cutoff score for this measure, as it is an exploratory question and we are only looking at trends in the data, and not statistically different results among groups.	Up to 52 weeks postpartum
Other	Maternal coping	Maternal coping will be measured using the proactive coping inventory	Up to 52 weeks postpartum
Primary	PTSD	PTSD severity will be measured using the PTSD Checklist - Civilian Version	Up to 52 weeks postpartum
Secondary	Maternal-infant attachment	Maternal-infant attachment will be measured using the Maternal Attachment Inventory	Up to 52 weeks postpartum
Secondary	Presence of postpartum depression	Presence of depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale (EPDS). Scores greater than 12 on the EPDS will be considered positive for postpartum depression. Scores between 0-12 will be considered "low probability of depression", scores 13 and above (13-30) will be considered "high probability of depression"	Up to 52 weeks postpartum
Secondary	Anxiety	Severity of anxiety will be measured using the State-Trait Anxiety Inventory	Up to 52 weeks postpartum