Stress Disorders, Post-TraumaticPATHNCT03536442
Promoting Attachment Through Healing
An observational study of Stress Disorders, Post-Traumatic and Depressive Disorder, run by Western University, Canada at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impact of Trauma-informed Cognitive Behavioural Therapy Among At-risk Pregnant Women on Perinatal Mental Health Outcomes: A Pilot Study
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.
Read the 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.
- Keywords
- antenatal, postpartum, mental health
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (CBT) | As there is only one arm in this trial, this will be described in "intervention". |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
PTSD severity will be measured using the PTSD Checklist - Civilian Version
Measured: Up to 52 weeks postpartum
Secondary outcomes (3)
Maternal-infant attachment
Maternal-infant attachment will be measured using the Maternal Attachment Inventory
Measured: Up to 52 weeks postpartum
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"
Measured: Up to 52 weeks postpartum
Anxiety
Severity of anxiety will be measured using the State-Trait Anxiety Inventory
Measured: Up to 52 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Jan 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Principal investigator, Kim Jackson, Western University, Canada
- Investigators
- Kimberley T Jackson, PhD, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536442
- Sponsor's protocol ID
- 10016616
- Other IDs
- R5498A03
- Acronym
- PATH
- Status last verified
- May 2019
- First submitted
- 8 May 2017
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization. World report on violence and health. Geneva: World Health Organization; 2002
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.
PubMed 17027732Campbell JC. Health consequences of intimate partner violence. Lancet. 2002 Apr 13;359(9314):1331-6. doi: 10.1016/S0140-6736(02)08336-8.
PubMed 11965295Afifi 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.
PubMed 18718882Coker 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.
PubMed 12165164Golding JM. Intimate partner violence as a risk factor for mental disorders: A meta-analysis. J Fam Violence. 1999;6:81-95.
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.
PubMed 15534333Seng 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.
PubMed 20482290Seng 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.
PubMed 18984507Jones L, Hughes M, Unterstaller U. Post-traumatic stress disorder (PTSD) in victims of domestic violence. Trauma, Violence, Abuse. 2001;2(2):99-119
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.
PubMed 11074228Ahluwalia 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.
PubMed 11339910Rheingold 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
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.
PubMed 24770992Jackson 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
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Trauma-informed Cognitive Behavioural Therapy Among At-risk Pregnant Women on Perinatal Mental Health Outcomes: A Pilot Study
- ClinicalTrials.gov ID
- NCT03536442
- Acronym / sponsor ID
- PATH / 10016616
- Keywords
- antenatal, postpartum, mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention (CBT) | – | –As there is only one arm in this trial, this will be described in "intervention". |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PTSD
Time frame: Up to 52 weeks postpartum
PTSD severity will be measured using the PTSD Checklist - Civilian Version
3 secondary outcomes
Maternal-infant attachment
Time frame: Up to 52 weeks postpartum
Presence of postpartum depression
Time frame: Up to 52 weeks postpartum
Anxiety
Time frame: Up to 52 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- BackgroundWorld Health Organization. World report on violence and health. Geneva: World Health Organization; 2002
- Background: PubMed 17027732Garcia-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.
- Background: PubMed 11965295Campbell JC. Health consequences of intimate partner violence. Lancet. 2002 Apr 13;359(9314):1331-6. doi: 10.1016/S0140-6736(02)08336-8.
- Background: PubMed 18718882Afifi 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.
- Background: PubMed 12165164Coker 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.
- BackgroundGolding JM. Intimate partner violence as a risk factor for mental disorders: A meta-analysis. J Fam Violence. 1999;6:81-95.
- Background: PubMed 15534333Plichta 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.
- Background: PubMed 20482290Seng 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.
- Background: PubMed 18984507Seng 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.
- BackgroundJones L, Hughes M, Unterstaller U. Post-traumatic stress disorder (PTSD) in victims of domestic violence. Trauma, Violence, Abuse. 2001;2(2):99-119
- Background: PubMed 11074228Breslau 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.
- Background: PubMed 11339910Ahluwalia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberley T Jackson, PhD principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic and Depressive Disorder, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD (time frame: Up to 52 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536442, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.