Cortisol Evaluation in Abuse Survivors

NCT01632553 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2015-12-07

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV
  • University College, London

    collaborator OTHER
  • University Hospitals Bristol and Weston NHS Foundation Trust

    collaborator OTHER
  • Survive South Gloucestershire and Bristol

    collaborator UNKNOWN
  • University of Bristol

    lead OTHER

Principal Investigators

  • Gene Feder, Professor · University of Bristol, Centre for Academic Primary Care

  • Stafford Lightman, Professor · University of Bristol, School of Clinical Sciences

  • Natalia Lokhmatkina, PhD · University of Bristol, School of Clinical Sciences

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632553 on ClinicalTrials.gov