Cortisol Evaluation in Abuse Survivors (CEASE)
This study looks at the biological effect of domestic violence and abuse (DVA) on women's mental health. The mechanisms through which DVA causes mental disorders are very poorly understood. Similar to other demands, DVA activates the biological stress system, of which the chief component is the hypothalamic-pituitary-adrenal (HPA) axis, which produces chemical cortisol. Cortisol levels increase in response to short-term demand and help organisms deal with it by changing the processes of getting energy from food and also mental function. However constant activation of the HPA axis can cause damage and accelerate disease.
This study tests the hypothesis that compared to non-abused women all abuse victims have altered diurnal rhythm in cortisol secretion and that the pattern of this alteration is predicted by abuse characteristics, such as its type, severity, duration, and cessation. To examine the hypothesis the following research questions will be addressed: 1) whether cortisol levels are related to mental health state; 2) whether cortisol levels are related to type, severity, duration and cessation of DVA; 3) whether there is any difference in cortisol concentrations between those women exposed to both childhood abuse and DVA and those who have experienced only the latter; 4) whether cortisol levels vary between women, living in refuge and those not living in refuge?
To answer these research questions 214 women will be recruited in a domestic violence agency. Baseline and 3-monthly follow-up measures will be taken over 6 months after recruitment. Women will be asked to fill in a questionnaire to evaluate their demographics, health, experience of childhood abuse and DVA. Women's weight and height will be taken. In addition participants will be asked to take three saliva samples: 1st in the evening in bed, 2nd - next morning immediately upon awakening, and the 3rd - in thirty minutes after awakening. Saliva will be collected by chewing (for 2 minutes) the cotton pledget provided with plastic tube and returned by post or via collection by the researcher. Then the saliva samples will be tested for cortisol and cortisone.
Results of the study will increase our understanding of the biological mechanisms of DVA impact on a woman's health and tell researchers and practitioners about the possibility of using cortisol as an indicator to diagnose abuse-related health problems and assess effectiveness of medical care for abuse survivors.
Posttraumatic Stress Disorders
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Longitudinal Measurement of Cortisol in Association With Mental Health and Experience of Domestic Violence and Abuse|
- Diurnal cortisol variation [ Time Frame: Baseline, and at 3 and 6 months after baseline ] [ Designated as safety issue: No ]Difference between awakening and bedtime cortisol concentrations. Assay: Ultra performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS). Unit of measure - nmol/l.
- Cortisol awakening response (CAR) [ Time Frame: Baseline, and at 3 and 6 months after baseline ] [ Designated as safety issue: No ]Difference between awakening and post awakening cortisol concentrations. Assay: UPLC - MS/MS. Unit of measure - nmol/l.
- Mean salivary cortisol concentration [ Time Frame: Baseline, and at 3 and 6 months after baseline ] [ Designated as safety issue: No ]Sum of awakening, post awakening, and bedtime cortisol concentrations. Assay: UPLC - MS/MS. Unit of measure - nmol/l.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
women who have experienced DVA
women who have not experienced DVA
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632553
|Survive South Gloucestershire and Bristol|
|Kingswood, Bristol, United Kingdom, BS15 8XJ|
|Bristol, United Kingdom, BS1 4JQ|
|Principal Investigator:||Gene Feder, Professor||University of Bristol, Centre for Academic Primary Care|
|Study Chair:||Stafford Lightman, Professor||University of Bristol, School of Clinical Sciences|
|Study Director:||Natalia Lokhmatkina, PhD||University of Bristol, School of Clinical Sciences|