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OpenTrials
Completed

NCT Number: NCT03536442

Promoting Attachment Through Healing

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PTSD

    Time frame: Up to 52 weeks postpartum

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

Secondary outcomes

  1. Maternal-infant attachment

    Time frame: Up to 52 weeks postpartum

    Maternal-infant attachment will be measured using the Maternal Attachment Inventory

  2. 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"

  3. Anxiety

    Time frame: Up to 52 weeks postpartum

    Severity of anxiety will be measured using the State-Trait Anxiety Inventory

Other outcomes

  1. 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.

  2. Maternal coping

    Time frame: Up to 52 weeks postpartum

    Maternal coping will be measured using the proactive coping inventory

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • London Health Sciences Centre

Registry information

Official study title

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

Acronym: PATH

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 24, 2018
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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