Promoting Attachment Through Healing (PATH)
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|ClinicalTrials.gov Identifier: NCT03536442|
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : May 23, 2019
|Condition or disease|
|Stress Disorders, Post-Traumatic Depressive Disorder Anxiety Disorders|
IPV is a pervasive public health problem , with estimates of approximately 50% of Canadian women experiencing IPV at least once during their lifetime . 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 . PTSD can alter psychological functioning and is associated with depression , disordered eating, substance abuse, sexual risk exposures and re-victimization  and failure to engage in health promotion strategies such as exercise, diet and routine health care ; 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  in addition to adverse effects on maternal functioning such as maternal-child attachment . 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 . There is a critical need for individualized, trauma-informed care to facilitate optimal maternal and child attachment outcomes . Fortunately, effective PTSD treatments exist, such as CBT; however, research exploring CBT in pregnant populations is lacking . As such, the purpose of this study is to explore the effectiveness of CBT for the treatment of IPV-related PTSD among antenatal women.
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|Official Title:||Examining the Impact of Trauma-informed Cognitive Behavioural Therapy Among At-risk Pregnant Women on Perinatal Mental Health Outcomes: A Pilot Study|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||December 1, 2018|
As there is only one arm in this trial, this will be described in "intervention".
- PTSD [ Time Frame: Up to 52 weeks postpartum ]PTSD severity will be measured using the PTSD Checklist - Civilian Version
- Maternal-infant attachment [ Time Frame: Up to 52 weeks postpartum ]Maternal-infant attachment will be measured using the Maternal Attachment Inventory
- Presence of postpartum depression [ Time Frame: Up to 52 weeks postpartum ]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"
- Anxiety [ Time Frame: Up to 52 weeks postpartum ]Severity of anxiety will be measured using the State-Trait Anxiety Inventory
- Maternal quality of life [ Time Frame: Up to 52 weeks postpartum ]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.
- Maternal coping [ Time Frame: Up to 52 weeks postpartum ]Maternal coping will be measured using the proactive coping inventory
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536442
|London Health Sciences|
|London, Ontario, Canada, N6A5W9|
|Principal Investigator:||Kimberley T Jackson, PhD||University of Western Ontario, Canada|