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Promoting Attachment Through Healing (PATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536442
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
London Health Sciences Centre
Information provided by (Responsible Party):
Kim Jackson, Western University, Canada

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.

Condition or disease
Stress Disorders, Post-Traumatic Depressive Disorder Anxiety Disorders

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.

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort
Intervention (CBT)
As there is only one arm in this trial, this will be described in "intervention".



Primary Outcome Measures :
  1. PTSD [ Time Frame: Up to 52 weeks postpartum ]
    PTSD severity will be measured using the PTSD Checklist - Civilian Version


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study applies to postpartum women
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
London Health Sciences
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
Western University, Canada
London Health Sciences Centre
Investigators
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Principal Investigator: Kimberley T Jackson, PhD University of Western Ontario, Canada
Publications:
World Health Organization. World report on violence and health. Geneva: World Health Organization; 2002
Golding JM. Intimate partner violence as a risk factor for mental disorders: A meta-analysis. J Fam Violence. 1999;6:81-95.
Jones L, Hughes M, Unterstaller U. Post-traumatic stress disorder (PTSD) in victims of domestic violence. Trauma, Violence, Abuse. 2001;2(2):99-119
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kim Jackson, Assistant Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT03536442    
Other Study ID Numbers: 10016616
R5498A03 ( Other Grant/Funding Number: Women's Xchange $15K Challenge Grant )
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kim Jackson, Western University, Canada:
antenatal
postpartum
mental health
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Anxiety Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Mood Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders