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.

backgroundIntimate partner violence (IPV) is a pervasive public health problem, impacting the health and quality of life of survivors worldwide. The trauma of IPV is associated with a high incidence of mental illness, namely depressive and anxiety disorders, and posttraumatic stress disorder (PTSD). Moreover, literature endorses cognitive behavioral therapy (CBT) interventions as a gold standard for those with symptomatology consistent with anxiety disorders, mood disorders, and PTSD. However, efficacy has not been evaluated among a population of pregnant survivors of IPV.

objectiveWe present the protocol that will be used to explore the efficacy of trauma-informed cognitive behavioral therapy on maternal and child health outcomes for pregnant women with PTSD, depression, or anxiety symptomatology resulting from IPV. A secondary aim will be to test the validity and feasibility of study methodology to support the successful implementation of a full-scale randomized controlled trial.

methodsThe Promoting Attachment Through Healing (PATH) study will use a mixed-methods approach grounded in an intersectional feminist framework to explore the effectiveness of trauma-informed CBT for pregnant survivors of IPV. Study participants will be recruited through the hospital-based Perinatal Mental Health Clinic (London, Ontario, Canada). A feasibility sample of 20 pregnant women (cohort 1) will be selected to engage in an eight-session antenatal CBT intervention facilitated by the program's perinatal clinical nurse specialist, with evaluation at baseline, at two months postpartum (intervention and online questionnaire), and at six and twelve months postpartum (online questionnaire only). Concurrently, we will conduct a retrospective audit of 100 medical charts (cohort 2; 50 charts of perinatal women who received CBT and 50 charts of women who did not receive perinatal CBT) from the past five years. The efficacy of the intervention will be based on a reduction of mental illness symptomatology, improved maternal-infant attachment, maternal coping, and maternal quality of life. Additionally, the feasibility of the protocol and acceptability of the intervention from the women's perspective will be examined. Inductive content analysis of all qualitative data will be used to determine common themes. Additionally, descriptive statistics, including measures of central tendency and dispersion, will be computed for all continuous variables. Alternatively, frequency tables will be constructed for all categorical variables.

resultsThe work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Participant recruitment for cohort 1 has started and we have finished data collection for cohort 2. It is anticipated that the results will be available by the end of 2018.

conclusionsFindings will assess the acceptability of the study methodology and protocol for a full-scale randomized controlled trial. Furthermore, if CBT is proven effective for pregnant survivors of IPV, this intervention could be readily adopted by health care and social support services, thereby contributing to an improved standard of care for this unique population.

trial registrationClinicalTrials.gov NCT03536442; https://www.clinicaltrials.gov/ct2/show/NCT03536442 (Archived by WebCite at http://www.webcitation.org/6zeurv1ay). REGISTERED REPORT IDENTIFIER: RR1-10.2196/9820.