AzTrials
AzTrials

Violence, DomesticBRAWNCT03623555

Applied Social Neuroscience: the Building Resilience Among Women Project

An observational study of Violence, Domestic and Stress Related Disorder, run by Ximena Goldberg at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Intimate partner violence (IPV) is the most common and alarming form of violence against women, affecting up to 25% of all women in Catalonia. It is a complex phenomenon that involves aspects of social interaction, cognitive-emotional processes, neurobiological alterations and cultural context. Read more about this study

Who is it for?
Ages 25 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Trier Social Stress Test and Salivary cortisol
How many people
172 participants
Where
1 siteSpain
Study dates
1 Mar 2019to Sep 2020
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 25 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: The population under study are women between 25 and 45 years of age

Who may be able to join

  • E-IPV group: - past history of at least 1 year of IPV exposure after the age of 18.
  • At least one year of established cessation of exposure to IPV
  • Subgroup with childhood maltreatment: - history of childhood maltreatment before the age of 16.
  • NE-IPV group: - no history of IPV lifetime
  • no history of childhood maltreatment
  • Subgroup with major depression disorder: - Presence of major depression disorder in the last year
  • Two groups of women will be included: women exposed to IPV (E-IPV), and women not ex-posed to IPV (NE-IPV). Inclusion criteria for the E-IPV group: (Index of Spouse Abuse18,19; Woman Abuse Screening Tool20,21). Inclusion criteria for the NE-IPV group: no history of IPV or any other form of chronic exposure to violent behaviour. Exclusion criteria for both groups: inability to read or comprehend instructions, pregnancy, current use of steroid-based medications and/or presence of any endocrine alteration. Groups will be matched by age, socioeconomic position and educational level.

Who cannot join

  • Age under 25 or over 45 years old.
  • Endocrine alteration, including steroid-based illness/medication
  • Pregnancy (last 6 months), current breast-feeding.
  • Current disability or illness that may cause inability to read or comprehend instructions

Trial locations and contacts

1 site in 1 country.

Ximena Goldberg, PhD contact

+34 937240182

xlgoldberg@tauli.cat

Spain1 site, 1 recruiting
  • Parc Taulí University Hospital

    Sabadell, Barcelona

    Ximena Goldberg, PhD, +34937240182 ext. 22205, xlgoldberg@tauli.cat

    Recruiting

Other trials in Spain

About this study

Official title: Building Resilience Among Women: a Social Neuroscience Approach for the Prevention of Intimate Partner Violence Consequences

Intimate partner violence (IPV) is the most common and alarming form of violence against women, affecting up to 25% of all women in Catalonia. It is a complex phenomenon that involves aspects of social interaction, cognitive-emotional processes, neurobiological alterations and cultural context. Using an integrative methodology, IPV will be approached as a form of chronic exposure to severe stress that alters the stress-response system of exposed women, affecting their capacity to cope with future everyday situations. Fortunately, coping strategies can be subject to change through learning mechanisms and thus the identification of vulnerabilities can help build resilience strategies that may have a long-lasting impression on women's healthy functioning.

It is proposed that the sustained exposure to violent social interactions impacts two key aspects of future behavior: i) altered psychosocial coping, and ii) enhanced emotional reactivity to acute stress. To test this hypothesis, the psychosocial and neurobiological response to common social acute stress will be analyzed among women with and without previous exposure to IPV. The Trier Social Stress Task (TSST) will be used, which is a valid test of acute stress that resembles the real life situation of a (mock) job interview. Based on a social neuroscience perspective, quantitative and qualitative measures will be used of cognitive performance, neuroendocrine activity and face-to-face interviews to obtain an integrative description of the response to the TSST that includes the personal narrative of the experience by women themselves.

Finally, the proposal will benefit from the fact that all participants will share the same experimental condition (the TSST), and this mock job interview will be used as the common reference point for a workshop about the difficulties and strengths put to test during a stressful situation. The focus of this workshop will be on raising awareness of such coping limitations and abilities that participants themselves will be able to identify. The results of this workshop will inform guidelines and recommendations for future work and prevention strategies, and participants will be invited to be an active part in our dissemination strategy

Read the detailed description

The burden and prevalence of intimate partner violence (IPV) has helped recognized this issue as a global public health problem, one of particular interest in the field of mental health as women who suffer intimate partner violence present an increased prevalence of depression compared with non-exposed women. The devastating consequences of IPV on women's health have been attributed to an enduring impact of IPV on the stress system that has long-term consequences on the victim's quality of life and are mediated by changes in neuroendocrine system, particularly the hypothalamic-pituitary-adrenal (HPA) axis.

Despite the critical importance of this stress system, most research on IPV has merely evaluated basal HPA activity, leaving unanswered the question of responsiveness: do women previously exposed to IPV have difficulties when coping with new emotional situations? The activation of the stress system in response to novel stressful situations is a central matter as it reflects the person's capacity to respond to the changing demands that commonly occur at work and at home. Biases for threat have been linked to chronic stress and violence, and are associated with HPA axis activity.

Under these conditions, an altered stress response may have important consequences in women's future development. For example, a job interview could be a stressful circumstance that affected women may have to face after recovering from IPV. The performance during the interview (i.e. getting or losing the job opportunity) will largely depend on the person's vulnerability to emotionally stressful situations or, on the contrary, on the successful strategies women may present to cope with acute stress. The present proposal aims at identifying these learnt vulnerabilities and resilience resources among IPV-exposed women, using valid measures of psychosocial and neuroendocrine response to acute stress.

It is hypothesized that women exposed to IPV will present a profile of increased stress vulnerability characterized by: i) a sensitized HPA axis response to acute stress, and ii) a dysfunctional psychosocial response.

To test this hypothesis, a group of women with a history of IPV will be compared to a group of women without such history from the same community in order to: 1) Assess the long-term impact of IPV on the patterns of psychosocial coping (i.e. personal attitudes and perceptions, and selective attentional processing bias) and neuroendocrine response to acute stress, 2) Examine the association between IPV and an "increased vulnerability to stress profile" characterized by dysfunctional psychosocial and neuroendocrine responses to acute stress, 3) Identify the strategies used by resilient women (psychosocial schemes, neuroendocrine regulation) to cope with acute stress, and 4) Explore the value of the above findings to inform the development of prevention resources for IPV-exposed women and at-risk groups.

Procedures: Adult women will be recruited from the Primary attention unit and the Adults Mental Health Unit at the reference Hospital. Three main groups of women will be included: women exposed to intimate partner violence (E-IPV), women not exposed to IPV (NE-IPV), and not exposed to IPV with major depression disorder. This last group will provide a comparison group in relation to mental health disorders. Groups will be matched by age, socioeconomic position and educational level.

Sample size calculation: The task used to assess stress reactivity (Trier social stress task) reliably activates the HPA axis and triggers a two- to three-fold release of cortisol in about 70-80% of participants. Assuming an increase in hormones with the task of about 70% and a standard deviation of 30% of the mean, a sample size of 43 participants per group will be needed to detect differences among the two groups of half of this increase with a power of 0.80 and an alpha of 0.05. Therefore, the complete sample will include: i) the E-IPV group composed of 90 women, 43 of them with history of childhood abuse and 43 of them without such history, and ii) a NE-IPV group composed of 90 women, 43 of them healthy controls and 43 with a diagnosis of major depression disorder. Total sample size: 172 women.

Work plan: After identification of the participants according to the project's criteria, women will be contacted by a researcher and one interviewer will be assigned to each woman all through the assessment. The objectives and the activities of this study will be clearly differentiated from those of any assistance that participants may be receiving in other services. Women willing to receive a full laboratory and hair cortisol analysis will be referred for blood extraction and collection of hair sample. Assessments will be performed in two different days separated by a two-week period. On day one, participants will respond to the initial interview including demographics, clinical and physical information. On day two, participants will respond to a social stress task that will be followed by a post-task face-to-face interview. A saliva sample will be collected before the beginning of the task, again 10 minutes after the beginning of the task, and finally 30 minutes after the beginning of the task.

Data analysis: A detailed descriptive analysis will be run that includes the information from the initial interview and the neuroendocrine response trajectories during the TSST. With this information groups will be compared (E-IPV with and without childhood abuse, and NE-IPV with and without depression) to test for putative psychosocial and neurobiological differences at the level of stress response. These data will be analysed with standard statistical methods and the Statistical Package of Social Sciences (SPSS, Chicago) software.

Ethical considerations: Following WHO's recommendations, participants who come to the interview accompanied by their partners will not be included. No participant will be excluded on the basis of their ethnicity, religion or sexual orientation. Written informed consent (previously approved by the Ethics Committee) will be obtained after a full description of the study's aims and design. Participants will be informed of the confidentiality of their comments following data protection laws (European data protection law: 2016/679). Registry and use of information resulting from this study will follow the Declaration of Helsinki agreements and local laws on biomedical research (Law 14/2007 of Biomedical Research). The collected data will be identified by means of a code that guarantees the confidentiality of the information. The results obtained from the analysis of the sample will be dissociated from the personal data and the health information obtained. Biological samples will be stored under a collection located in the Hospital laboratories, from which the main researcher of the study will be the holder, and that will be registered in the National Registry of Biobanks.

Being tested
Trier Social Stress Test, Salivary cortisol
Keywords
Stress regulation, Depression, Intimate partner violence, Resilience, Psychophysiology, Endocrine response, Risk factor
Medical subject headings
Depressive Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trier Social Stress TestBehavioural

    The participants are instructed to imagine having applied for their "dream job" and that they are now invited to a job interview. The TSST consists of three successive phases: (1) A preparation period (3min), (2) a free speech task in which the participants have to argue why they are the best candidate for the job they wish to apply for (5min), and (3) a mental arithmetic task in which participants have to sequentially subtract an odd two-digit number from an odd four-digit number (e.g., 17 from 2023; 5min). The two tasks are performed in front of a selection committee (two members), dressed in white lab coats, acting in a reserved manner and providing no facial or verbal feedback.

  • Salivary cortisolBiological

    Saliva samples will be obtained by means of Salivette collection devices before, 10 minutes after, and 30 minutes after the beginning of the TSST

Study groups in NCT03623555
Study groupRoleWhat they receive
E-IPVWomen who have been exposed to intimate partner violence. Half of this group will also have a history of childhood maltreatment. Women will be assessed for behavioral performance during the Trier Social Stress Test, and salivary cortisol will be collected.
Receives: Behavioral: Trier Social Stress Test; Biological: Salivary cortisol
NE-IPVWomen who have never been exposed to intimate partner violence. Half of this group will also present a diagnosis of Major Depressive Disorder. Women will be assessed for behavioral performance during the Trier Social Stress Test, and salivary cortisol will be collected.
Receives: Behavioral: Trier Social Stress Test; Biological: Salivary cortisol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary cortisol

    Salivary cortisol concentration levels

    Measured: Recovery after acute stress response experiment (TSST): 45 minutes

Secondary outcomes (1)
  1. Behavioral response

    Behavioral performance during acute stress response experiment (TSST)

    Measured: Recovery after acute stress response experiment (TSST): 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2018
  2. Study start1 Mar 2019
  3. Primary completionJan 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

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
Retrospective
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03623555
Sponsor's protocol ID
BRAW2018
Acronym
BRAW
Status last verified
May 2019
First submitted
23 Jul 2018
Last updated
6 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Li SH, Graham BM. Why are women so vulnerable to anxiety, trauma-related and stress-related disorders? The potential role of sex hormones. Lancet Psychiatry. 2017 Jan;4(1):73-82. doi: 10.1016/S2215-0366(16)30358-3. Epub 2016 Nov 15.

    PubMed 27856395
  • Kuehner C. Why is depression more common among women than among men? Lancet Psychiatry. 2017 Feb;4(2):146-158. doi: 10.1016/S2215-0366(16)30263-2. Epub 2016 Nov 15.

    PubMed 27856392
  • Inslicht SS, Marmar CR, Neylan TC, Metzler TJ, Hart SL, Otte C, McCaslin SE, Larkin GL, Hyman KB, Baum A. Increased cortisol in women with intimate partner violence-related posttraumatic stress disorder. Psychoneuroendocrinology. 2006 Aug;31(7):825-38. doi: 10.1016/j.psyneuen.2006.03.007. Epub 2006 May 23.

    PubMed 16716530
  • Pinna KL, Johnson DM, Delahanty DL. PTSD, comorbid depression, and the cortisol waking response in victims of intimate partner violence: preliminary evidence. Anxiety Stress Coping. 2014 May;27(3):253-69. doi: 10.1080/10615806.2013.852185. Epub 2013 Nov 28.

    PubMed 24283327
  • Belda X, Fuentes S, Daviu N, Nadal R, Armario A. Stress-induced sensitization: the hypothalamic-pituitary-adrenal axis and beyond. Stress. 2015;18(3):269-79. doi: 10.3109/10253890.2015.1067678. Epub 2015 Aug 17.

    PubMed 26300109
  • Oram S, Khalifeh H, Howard LM. Violence against women and mental health. Lancet Psychiatry. 2017 Feb;4(2):159-170. doi: 10.1016/S2215-0366(16)30261-9. Epub 2016 Nov 15.

    PubMed 27856393
  • Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.

    PubMed 8255414
  • Frisch JU, Hausser JA, Mojzisch A. The Trier Social Stress Test as a paradigm to study how people respond to threat in social interactions. Front Psychol. 2015 Feb 2;6:14. doi: 10.3389/fpsyg.2015.00014. eCollection 2015.

    PubMed 25698987
  • Goldberg X, Espelt C, Palao D, Nadal R, Armario A. Adaptability to acute stress among women survivors of intimate partner violence: protocol for a mixed-methods cross-sectional study in a laboratory setting (BRAW study). BMJ Open. 2020 Oct 1;10(10):e036561. doi: 10.1136/bmjopen-2019-036561.

    PubMed 33004387

Questions about this trial

What is this clinical trial studying?

An observational study of Violence, Domestic and Stress Related Disorder, run by Ximena Goldberg at 1 site in Spain.

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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ximena Goldberg, PhD (+34 937240182, xlgoldberg@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary cortisol (time frame: Recovery after acute stress response experiment (TSST): 45 minutes). 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 NCT03623555, which also lists 9 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 6 May 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in