Domestic ViolenceCEASENCT01632553
Cortisol Evaluation in Abuse Survivors
An observational study of Domestic Violence and Depression, run by University of Bristol at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence, Depression, Anxiety
- How many people
- 214 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2012to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- age ≥ 18 y.o.
Who cannot join
- unable to read English
- current use of steroid-based medications
- pregnancy
- presence of adrenal and/or pituitary gland disorder
- symptomatic psychotic illness.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Next Link
Bristol, BS1 4JQ
Survive South Gloucestershire and Bristol
Kingswood, Bristol, BS15 8XJ
About this study
Official title: Longitudinal Measurement of Cortisol in Association With Mental Health and Experience of Domestic Violence and Abuse
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?
Read more
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.
Read the 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 experience of DVA and in non-abused controls
- To estimate whether cortisol secretion is associated with type, severity, duration and cessation of DVA
- 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 DVA 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 6-month study will consist of 3 measurements every 3 months. Each assessment will last approximately 30-45 minutes and will include:
- Numerous standardized self-administered psychological questionnaires
- Weight and height measurement
- Self-completion of 3 saliva samples using Salivette tubes:
- evening sample - at bedtime
- awakening sample - in the morning immediately upon wakening
- post-awakening sample - 30 mins after awakening sample
Tubes with saliva 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.
- Keywords
- Observation, Domestic Violence, Partner Abuse, Spousal Abuse, Battered Women, Abused Women, Cortisol, Mental Health, Depression, Anxiety, Posttraumatic Stress Disorders
- Medical subject headings
- Depression, Anxiety Disorders, Panic Disorder, Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | women who have experienced DVA | |
| Controls | women who have not experienced DVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal cortisol variation
Difference between awakening and bedtime cortisol concentrations. Assay: Ultra performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS). Unit of measure - nmol/l.
Measured: Baseline, and at 3 and 6 months after baseline
Secondary outcomes (2)
Cortisol awakening response (CAR)
Difference between awakening and post awakening cortisol concentrations. Assay: UPLC - MS/MS. Unit of measure - nmol/l.
Measured: Baseline, and at 3 and 6 months after baseline
Mean salivary cortisol concentration
Sum of awakening, post awakening, and bedtime cortisol concentrations. Assay: UPLC - MS/MS. Unit of measure - nmol/l.
Measured: Baseline, and at 3 and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University College, London, University Hospitals Bristol and Weston NHS Foundation Trust, Survive South Gloucestershire and Bristol
- Responsible party
- Principal investigator, Gene Feder, University of Bristol
- Investigators
- Gene Feder, Professor, Principal investigator, University of Bristol, Centre for Academic Primary CareStafford Lightman, Professor, Study chair, University of Bristol, School of Clinical SciencesNatalia Lokhmatkina, PhD, Study director, University of Bristol, School of Clinical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632553
- Sponsor's protocol ID
- 1678
- Other IDs
- NF110946, SOCSRG2594, insurance/CT1349
- Acronym
- CEASE
- Status last verified
- Dec 2015
- First submitted
- 28 Jun 2012
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Feder G, Ramsay J, Dunne D, Rose M, Arsene C, Norman R, Kuntze S, Spencer A, Bacchus L, Hague G, Warburton A, Taket A. How far does screening women for domestic (partner) violence in different health-care settings meet criteria for a screening programme? Systematic reviews of nine UK National Screening Committee criteria. Health Technol Assess. 2009 Mar;13(16):iii-iv, xi-xiii, 1-113, 137-347. doi: 10.3310/hta13160.
PubMed 19272272Campbell JC. Health consequences of intimate partner violence. Lancet. 2002 Apr 13;359(9314):1331-6. doi: 10.1016/S0140-6736(02)08336-8.
PubMed 11965295Coid J, Petruckevitch A, Chung WS, Richardson J, Moorey S, Feder G. Abusive experiences and psychiatric morbidity in women primary care attenders. Br J Psychiatry. 2003 Oct;183:332-9; discussion 340-1. doi: 10.1192/bjp.183.4.332.
PubMed 14519611Golding JM. Intimate partner violence as a risk factor for mental disorders: A meta-analysis. Journal of Family Violence 14(2):99-132, 1999.
Kernic MA, Holt VL, Stoner JA, Wolf ME, Rivara FP. Resolution of depression among victims of intimate partner violence: is cessation of violence enough? Violence Vict. 2003 Apr;18(2):115-29. doi: 10.1891/vivi.2003.18.2.115.
PubMed 12816399Anderson DK, Saunders DG. Leaving an abusive partner: an empirical review of predictors, the process of leaving, and psychological well-being. Trauma Violence Abuse. 2003 Apr;4(2):163-91. doi: 10.1177/1524838002250769.
PubMed 14697121Lightman SL. The neuroendocrinology of stress: a never ending story. J Neuroendocrinol. 2008 Jun;20(6):880-4. doi: 10.1111/j.1365-2826.2008.01711.x.
PubMed 18601712Mirescu C, Gould E. Stress and adult neurogenesis. Hippocampus. 2006;16(3):233-8. doi: 10.1002/hipo.20155.
PubMed 16411244Pico-Alfonso MA, Garcia-Linares MI, Celda-Navarro N, Herbert J, Martinez M. Changes in cortisol and dehydroepiandrosterone in women victims of physical and psychological intimate partner violence. Biol Psychiatry. 2004 Aug 15;56(4):233-40. doi: 10.1016/j.biopsych.2004.06.001.
PubMed 15312810Seedat S, Stein MB, Kennedy CM, Hauger RL. Plasma cortisol and neuropeptide Y in female victims of intimate partner violence. Psychoneuroendocrinology. 2003 Aug;28(6):796-808. doi: 10.1016/s0306-4530(02)00086-0.
PubMed 12812865McFarlane AC, Barton CA, Yehuda R, Wittert G. Cortisol response to acute trauma and risk of posttraumatic stress disorder. Psychoneuroendocrinology. 2011 Jun;36(5):720-7. doi: 10.1016/j.psyneuen.2010.10.007. Epub 2010 Nov 19.
PubMed 21093988Heim C, Ehlert U, Hanker JP, Hellhammer DH. Abuse-related posttraumatic stress disorder and alterations of the hypothalamic-pituitary-adrenal axis in women with chronic pelvic pain. Psychosom Med. 1998 May-Jun;60(3):309-18. doi: 10.1097/00006842-199805000-00017.
PubMed 9625218Dutton MA, Green BL, Kaltman SI, Roesch DM, Zeffiro TA, Krause ED. Intimate partner violence, PTSD, and adverse health outcomes. J Interpers Violence. 2006 Jul;21(7):955-68. doi: 10.1177/0886260506289178.
PubMed 16731994Lokhmatkina NV, Feder G, Blake S, Morris R, Powers V, Lightman S. Longitudinal measurement of cortisol in association with mental health and experience of domestic violence and abuse: study protocol. BMC Psychiatry. 2013 Jul 13;13:188. doi: 10.1186/1471-244X-13-188.
PubMed 23849084
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Measurement of Cortisol in Association With Mental Health and Experience of Domestic Violence and Abuse
- ClinicalTrials.gov ID
- NCT01632553
- Acronym / sponsor ID
- CEASE / 1678
- Keywords
- Observation, Domestic Violence, Partner Abuse, Spousal Abuse, Battered Women, Abused Women, Cortisol, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University College, London, University Hospitals Bristol and Weston NHS Foundation Trust, Survive South Gloucestershire and Bristol
- Study start
- Aug 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 experience of DVA and in non-abused controls
- To estimate whether cortisol secretion is associated with type, severity, duration and cessation of DVA
- 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 DVA 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 6-month study will consist of 3 measurements every 3 months. Each assessment will last approximately 30-45 minutes and will include:
- Numerous standardized self-administered psychological questionnaires
- Weight and height measurement
- Self-completion of 3 saliva samples using Salivette tubes:
- evening sample - at bedtime
- awakening sample - in the morning immediately upon wakening
- post-awakening sample - 30 mins after awakening sample
Tubes with saliva 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –women who have experienced DVA |
| Controls | – | –women who have not experienced DVA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- age ≥ 18 y.o.
Key exclusion criteria (5 listed)
- unable to read English
- current use of steroid-based medications
- pregnancy
- presence of adrenal and/or pituitary gland disorder
- symptomatic psychotic illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diurnal cortisol variation
Time frame: Baseline, and at 3 and 6 months after baseline
Difference between awakening and bedtime cortisol concentrations. Assay: Ultra performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS). Unit of measure - nmol/l.
2 secondary outcomes
Cortisol awakening response (CAR)
Time frame: Baseline, and at 3 and 6 months after baseline
Mean salivary cortisol concentration
Time frame: Baseline, and at 3 and 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
- Background: PubMed 19272272Feder G, Ramsay J, Dunne D, Rose M, Arsene C, Norman R, Kuntze S, Spencer A, Bacchus L, Hague G, Warburton A, Taket A. How far does screening women for domestic (partner) violence in different health-care settings meet criteria for a screening programme? Systematic reviews of nine UK National Screening Committee criteria. Health Technol Assess. 2009 Mar;13(16):iii-iv, xi-xiii, 1-113, 137-347. doi: 10.3310/hta13160.
- Background: PubMed 11965295Campbell JC. Health consequences of intimate partner violence. Lancet. 2002 Apr 13;359(9314):1331-6. doi: 10.1016/S0140-6736(02)08336-8.
- Background: PubMed 14519611Coid J, Petruckevitch A, Chung WS, Richardson J, Moorey S, Feder G. Abusive experiences and psychiatric morbidity in women primary care attenders. Br J Psychiatry. 2003 Oct;183:332-9; discussion 340-1. doi: 10.1192/bjp.183.4.332.
- BackgroundGolding JM. Intimate partner violence as a risk factor for mental disorders: A meta-analysis. Journal of Family Violence 14(2):99-132, 1999.
- Background: PubMed 12816399Kernic MA, Holt VL, Stoner JA, Wolf ME, Rivara FP. Resolution of depression among victims of intimate partner violence: is cessation of violence enough? Violence Vict. 2003 Apr;18(2):115-29. doi: 10.1891/vivi.2003.18.2.115.
- Background: PubMed 14697121Anderson DK, Saunders DG. Leaving an abusive partner: an empirical review of predictors, the process of leaving, and psychological well-being. Trauma Violence Abuse. 2003 Apr;4(2):163-91. doi: 10.1177/1524838002250769.
- Background: PubMed 18601712Lightman SL. The neuroendocrinology of stress: a never ending story. J Neuroendocrinol. 2008 Jun;20(6):880-4. doi: 10.1111/j.1365-2826.2008.01711.x.
- Background: PubMed 16411244Mirescu C, Gould E. Stress and adult neurogenesis. Hippocampus. 2006;16(3):233-8. doi: 10.1002/hipo.20155.
- Background: PubMed 15312810Pico-Alfonso MA, Garcia-Linares MI, Celda-Navarro N, Herbert J, Martinez M. Changes in cortisol and dehydroepiandrosterone in women victims of physical and psychological intimate partner violence. Biol Psychiatry. 2004 Aug 15;56(4):233-40. doi: 10.1016/j.biopsych.2004.06.001.
- Background: PubMed 12812865Seedat S, Stein MB, Kennedy CM, Hauger RL. Plasma cortisol and neuropeptide Y in female victims of intimate partner violence. Psychoneuroendocrinology. 2003 Aug;28(6):796-808. doi: 10.1016/s0306-4530(02)00086-0.
- Background: PubMed 21093988McFarlane AC, Barton CA, Yehuda R, Wittert G. Cortisol response to acute trauma and risk of posttraumatic stress disorder. Psychoneuroendocrinology. 2011 Jun;36(5):720-7. doi: 10.1016/j.psyneuen.2010.10.007. Epub 2010 Nov 19.
- Background: PubMed 9625218Heim C, Ehlert U, Hanker JP, Hellhammer DH. Abuse-related posttraumatic stress disorder and alterations of the hypothalamic-pituitary-adrenal axis in women with chronic pelvic pain. Psychosom Med. 1998 May-Jun;60(3):309-18. doi: 10.1097/00006842-199805000-00017.
- protocol paper in Open AccessLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gene Feder, Professor principal investigator
University of Bristol, Centre for Academic Primary Care
Stafford Lightman, Professor study chair
University of Bristol, School of Clinical Sciences
Natalia Lokhmatkina, PhD study director
University of Bristol, School of Clinical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Domestic Violence and Depression, run by University of Bristol at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diurnal cortisol variation (time frame: Baseline, and at 3 and 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01632553, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.