Applied Social Neuroscience: the Building Resilience Among Women Project
NCT ID: NCT03623555
Last Updated: 2019-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
172 participants
OBSERVATIONAL
2019-03-01
2020-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Role of Executive Functioning in Complex Post-Traumatic Stress Disorder Among Female Survivors of Intimate Partner Violence
NCT06706882
Evaluating the Neurobiological Basis of Traumatic Dissociation in Women With Histories of Abuse and Neglect
NCT02757339
Psychosocial Intervention With Community Worker Support for Survivors of Intimate Partner Violence
NCT03333798
Stress & Social Cognition in BPD (part 2)
NCT05310253
Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
NCT01681849
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
E-IPV
Women 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.
Trier Social Stress Test
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 cortisol
Saliva samples will be obtained by means of Salivette collection devices before, 10 minutes after, and 30 minutes after the beginning of the TSST
NE-IPV
Women 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.
Trier Social Stress Test
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 cortisol
Saliva samples will be obtained by means of Salivette collection devices before, 10 minutes after, and 30 minutes after the beginning of the TSST
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Trier Social Stress Test
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 cortisol
Saliva samples will be obtained by means of Salivette collection devices before, 10 minutes after, and 30 minutes after the beginning of the TSST
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
25 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
La Caixa Foundation
OTHER
Universitat Autonoma de Barcelona
OTHER
Associació Catalana d'Universitats Públiques
UNKNOWN
Ximena Goldberg
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ximena Goldberg
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Parc Taulí University Hospital
Sabadell, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
World Health Organization. Global and regional estimates of violence against women: prevalence and health effects of intimate partner violence and non-partner sexual violence
Catalan Institute of Women. Violence against women, data from Catalonia
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BRAW2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.