Trial record 3 of 15 for:    Open Studies | "Domestic Violence"

Cortisol Evaluation in Abuse Survivors (CEASE)

This study is currently recruiting participants.
Verified September 2013 by University of Bristol
Sponsor:
Collaborators:
NIHR National School for Primary Care Research, United Kingdom
University College, London
University Hospitals Bristol NHS 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: September 20, 2013
Last verified: September 2013
  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 128 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. Participants will also be asked to collect three saliva samples: 1st in the morning upon awakening, 2nd - thirty minutes after awakening, and the 3rd - in the evening in bed. Saliva will be collected with plastic tubes with cotton swabs and returned by post or via collection by the researcher. Then the saliva samples will be analyzed 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: Cohort
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


Estimated Enrollment: 128
Study Start Date: August 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Domestic violence and abuse (DVA) is threatening behavior, violence or abuse (psychological, physical, sexual, financial or emotional) used by one person to control the other. Life time prevalence of DVA is 28% for women and 18% for men, although severity and consequences of abuse are less for men (1). Over and above damage to physical and reproductive health DVA has long-term detrimental effects on mental health for women consulting in primary care (2, 3). A meta-analysis of studies measuring the relationship between DVA and mental disorders reported increased risk for depression, anxiety, psychosomatic disorders, posttraumatic stress disorder (PTSD), alcohol abuse, and suicidal behavior (4). Kernic et al (5) have established that cessation of DVA among survivors is associated with decreased prevalence of depression; whereas Anderson and Sounders (6) have found that some women out of the abusive relationship may have greater psychological difficulties than those who are still in it. However the mechanisms through which DVA causes mental disease are very poorly understood. Similar to other stressors, DVA activates the biological stress system, of which the principal component is the hypothalamic-pituitary-adrenal (HPA) axis, which produces cortisol. Chronic activation of this system can result in dendritic retraction and hippocampal loss of function (7, 8). The results of existing cross-sectional studies testing the impact of DVA on women's HPA axis functioning are contradictory. Pico-Alfonso et al (9) have reported an increase in cortisol levels, whilst Seedat et al (10) have established reduction in cortisol levels in DVA subjects compared to controls. This disparity may relate to differential development of PTSD and/or depression within DVA-exposed samples (11). Currently, there is a hypothesis that DVA survivors may be characterized by alterations in the HPA axis (12) and that further longitudinal studies are needed to identify specific stress system disturbances in this group (1, 13). The aim of the study is to increase understanding of the role of hypothalamic-pituitary-adrenal (HPA) axis activity in DVA impact on women's mental health.

Study objectives:

  • To evaluate the profiles of the awakening response of cortisol, the diurnal variation and the mean salivary cortisol concentration in women with a current or recent experience of DVA
  • To estimate whether cortisol secretion is associated with type, severity, duration and cessation of domestic violence/abuse
  • To investigate whether cortisol acts as mediator between DVA and mental health state
  • To examine whether there is any distinction in cortisol levels between those women exposed to both childhood abuse and domestic violence and abuse and those experienced only the latter
  • To explore whether cortisol secretion differs between women, living in a domestic violence refuge/safe house and those still living in the community (after adjustment for confounding effects of abuse severity and continuing contact with abuser).

This 18-month study will consist of 3 measurements. Each assessment will last approximately 30-45 minutes and will include:

  1. Numerous standardized self-administered psychological questionnaires
  2. Weight and height measurement
  3. Self-completion of 3 saliva samples using Salivette tubes:

    1. awakening sample - in the morning immediately upon wakening.
    2. post-awakening sample - 30 mins after awakening sample.
    3. evening sample - at bedtime.

Tubes with saliva samples will be returned by post or by researcher to an accredited laboratory for cortisol assay. The analysis also simultaneously measures cortisone a breakdown product of cortisol. This measurement is used to confirm the integrity of the sample.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • age ≥ 18 y.o.

Exclusion Criteria:

  • unable to read English
  • current use of steroid-based medications
  • pregnancy
  • presence of endocrine disorder
  • symptomatic psychotic illness.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632553

Contacts
Contact: Natalia Lokhmatkina, PhD 44-0117-928-7246 Nat.Lokhmatkina@bristol.ac.uk

Locations
United Kingdom
Survive South Gloucestershire and Bristol Recruiting
Kingswood, Bristol, United Kingdom, BS15 8XJ
Contact: Natalia Lokhmatkina, PhD    44-0117-9287246    Nat.Lokhmatkina@bristol.ac.uk   
Principal Investigator: Natalia Lokhmatkina, PhD         
Sub-Investigator: Sarah Blake, MSc         
Sponsors and Collaborators
University of Bristol
NIHR National School for Primary Care Research, United Kingdom
University College, London
University Hospitals Bristol NHS 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

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: September 20, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Panic Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Behavioral Symptoms
Mood Disorders
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on April 16, 2014