Depressive Disorder Clinical Trial
— BRAWOfficial title:
Building Resilience Among Women: a Social Neuroscience Approach for the Prevention of Intimate Partner Violence Consequences
NCT number | NCT03623555 |
Other study ID # | BRAW2018 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | September 2020 |
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
Status | Recruiting |
Enrollment | 172 |
Est. completion date | September 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 45 Years |
Eligibility |
Inclusion Criteria for both groups: - 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. Exclusion Criteria (both groups): - 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Parc Taulí University Hospital | Sabadell | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Ximena Goldberg | Associació Catalana d’Universitats Públiques, Fundación Bancaria La Caixa, Universitat Autonoma de Barcelona |
Spain,
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. Review. — View Citation
Frisch JU, Häusser 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. Review. — View Citation
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. Epub 2006 May 23. Erratum in: Psychoneuroendocrinology. 2006 Nov;31(10):1295-6. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Salivary cortisol | Salivary cortisol concentration levels | Recovery after acute stress response experiment (TSST): 45 minutes | |
Secondary | Behavioral response | Behavioral performance during acute stress response experiment (TSST) | Recovery after acute stress response experiment (TSST): 45 minutes |
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