Jackson Kimberley T, Parkinson Sarah, Jackson Brianna, Mantler Tara
Labatt School of Nursing, Faculty of Health Sciences, The University of Western Ontario, London, ON, Canada.
London Health Sciences Center, London, ON, Canada.
JMIR Res Protoc. 2018 May 25;7(5):e134. doi: 10.2196/resprot.9820.
Intimate 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.
We 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.
The 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.
The 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.
Findings 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.
ClinicalTrials.gov NCT03536442; https://www.clinicaltrials.gov/ct2/show/NCT03536442 (Archived by WebCite at http://www.webcitation.org/6zeurv1ay).
RR1-10.2196/9820.
亲密伴侣暴力（IPV）是一个普遍存在的公共卫生问题，影响着全球幸存者的健康和生活质量。IPV造成的创伤与精神疾病的高发病率相关，即抑郁和焦虑症，以及创伤后应激障碍（PTSD）。此外，文献认可认知行为疗法（CBT）干预是针对有焦虑症、情绪障碍和PTSD症状者的黄金标准。然而，尚未在IPV的怀孕幸存者群体中评估其疗效。
我们介绍将用于探究创伤知情认知行为疗法对因IPV导致PTSD、抑郁或焦虑症状的孕妇母婴健康结局疗效的方案。第二个目的将是检验研究方法的有效性和可行性，以支持全面随机对照试验的成功实施。
通过治愈促进依恋（PATH）研究将采用基于交叉女权主义框架的混合方法，以探究创伤知情CBT对IPV怀孕幸存者的有效性。研究参与者将通过加拿大安大略省伦敦市的医院围产期心理健康诊所招募。将选择20名孕妇的可行性样本（队列1），由该项目的围产期临床护士专家进行为期八节的产前CBT干预，并在基线、产后两个月（干预和在线问卷）以及产后六个月和十二个月（仅在线问卷）进行评估。同时，我们将对过去五年的100份病历进行回顾性审核（队列2；50份接受CBT的围产期妇女病历和50份未接受围产期CBT的妇女病历）。干预的疗效将基于精神疾病症状的减轻、母婴依恋的改善、母亲的应对能力和母亲的生活质量。此外，将从女性角度检查方案的可行性和干预的可接受性。将对所有定性数据进行归纳性内容分析，以确定共同主题。此外，将为所有连续变量计算描述性统计数据，包括集中趋势和离散度的度量。或者，将为所有分类变量构建频率表。
此处报告的工作处于提案阶段。一旦方案实施，我们将在后续论文中报告结果。队列1的参与者招募已经开始且我们已完成队列2的数据收集。预计结果将于2018年底可得。
研究结果将评估全面随机对照试验的研究方法和方案的可接受性。此外，如果CBT被证明对IPV的怀孕幸存者有效，这种干预可被医疗保健和社会支持服务轻易采用，从而有助于提高这一独特群体的护理标准。
ClinicalTrials.gov NCT03536442；https://www.clinicaltrials.gov/ct2/show/NCT03536442（由WebCite存档于http://www.webcitation.org/6zeurv1ay）。
RR1 - 10.2196/9820。
