Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 3 of 53 for:    violence AND abuse AND (woman OR women OR female)

Cortisol Evaluation in Abuse Survivors (CEASE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NIHR National School for Primary Care Research, United Kingdom
University College, London
University Hospitals Bristol NHS Foundation Trust
Survive South Gloucestershire and Bristol
Information provided by (Responsible Party):
Gene Feder, University of Bristol
ClinicalTrials.gov Identifier:
NCT01632553
First received: June 28, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition
Domestic Violence
Depression
Anxiety
Panic Disorder
Posttraumatic Stress Disorders

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Bristol:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

Saliva


Enrollment: 214
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)
Groups/Cohorts
Cases
women who have experienced DVA
Controls
women who have not experienced DVA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women referred to two specialist domestic violence agencies for community outreach support or refuge accommodation by other agencies or self-referred. Non-abused friend and family controls will be recruited through index participants and in local communities through invitation letters displayed in public places in areas surrounding agencies sites.

Criteria

Inclusion Criteria:

  • age ≥ 18 y.o.

Exclusion Criteria:

  • unable to read English
  • current use of steroid-based medications
  • pregnancy
  • presence of adrenal and/or pituitary gland disorder
  • symptomatic psychotic illness.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632553

Locations
United Kingdom
Survive South Gloucestershire and Bristol
Kingswood, Bristol, United Kingdom, BS15 8XJ
Next Link
Bristol, United Kingdom, BS1 4JQ
Sponsors and Collaborators
University of Bristol
NIHR National School for Primary Care Research, United Kingdom
University College, London
University Hospitals Bristol NHS Foundation Trust
Survive South Gloucestershire and Bristol
Investigators
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
  More Information

Additional Information:
Publications:
Golding JM. Intimate partner violence as a risk factor for mental disorders: A meta-analysis. Journal of Family Violence 14(2):99-132, 1999.

Responsible Party: Gene Feder, Professor of Primary Health Care, Centre for Academic Primary Care, University of Bristol
ClinicalTrials.gov Identifier: NCT01632553     History of Changes
Other Study ID Numbers: 1678, NF110946, SOCSRG2594, insurance/CT1349
Study First Received: June 28, 2012
Last Updated: April 30, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Bristol:
Domestic Violence
Partner Abuse
Spousal Abuse
Battered Women
Abused Women
Observation
Cortisol
Mental Health
Depression
Anxiety
Posttraumatic Stress Disorders

Additional relevant MeSH terms:
Depression
Depressive Disorder
Disease
Panic Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014