Promoting Attachment Through Healing

NCT03536442 | Completed

• 2 other identifiers: 10016616R5498A03
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder; Anxiety Disorders

Keywords

antenatal; postpartum; mental health

Outcome Measures

Primary Outcomes (1)

• PTSD

  PTSD severity will be measured using the PTSD Checklist - Civilian Version

  Up to 52 weeks postpartum

Secondary Outcomes (3)

• Maternal-infant attachment

  Up to 52 weeks postpartum

• Presence of postpartum depression

  Up to 52 weeks postpartum

• Anxiety

  Up to 52 weeks postpartum

Other Outcomes (2)

• Maternal quality of life

  Up to 52 weeks postpartum

• Maternal coping

  Up to 52 weeks postpartum

Study Arms (1)

Intervention (CBT)

As there is only one arm in this trial, this will be described in "intervention".

Eligibility Criteria

• Gender Eligibility Details: This study applies to postpartum women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

London Health Sciences

London, Ontario, N6A5W9, Canada

Location

Related Publications (18)

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

  BACKGROUND

• 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.

  PMID: 17027732 BACKGROUND

• Campbell JC. Health consequences of intimate partner violence. Lancet. 2002 Apr 13;359(9314):1331-6. doi: 10.1016/S0140-6736(02)08336-8.

  PMID: 11965295 BACKGROUND

• 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.

  PMID: 18718882 BACKGROUND

• 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.

  PMID: 12165164 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 15534333 BACKGROUND

• 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.

  PMID: 20482290 BACKGROUND

• 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.

  PMID: 18984507 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 11074228 BACKGROUND

• 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.

  PMID: 11339910 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24770992 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20653342 BACKGROUND

• 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.

  PMID: 1593739 BACKGROUND

• 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.

  PMID: 29802091 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Mood Disorders; Personal Satisfaction; Behavior

Study Officials

• Kimberley T Jackson, PhD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 24, 2018
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)