Applied Social Neuroscience: the Building Resilience Among Women Project

NCT03623555 | Unknown

• 1 other identifier: BRAW2018
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Violence, Domestic; Stress Related Disorder; Depressive Disorder

Keywords

Stress regulation; Depression; Intimate partner violence; Resilience; Psychophysiology; Endocrine response; Risk factor

Outcome Measures

Primary Outcomes (1)

• Salivary cortisol

  Salivary cortisol concentration levels

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

Secondary Outcomes (1)

• Behavioral response

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

Study Arms (2)

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.

Behavioral: Trier Social Stress Test; Biological: Salivary cortisol

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.

Behavioral: Trier Social Stress Test; Biological: Salivary cortisol

Interventions

Trier Social Stress Test BEHAVIORAL

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.

E-IPV; NE-IPV

Salivary cortisol BIOLOGICAL

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

E-IPV; NE-IPV

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ximena Goldberg: lead
• La Caixa Foundation: collaborator
• Universitat Autonoma de Barcelona: collaborator
• Associació Catalana d'Universitats Públiques: collaborator

Study Sites (1)

Parc Taulí University Hospital

Sabadell, Barcelona, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 27856395 BACKGROUND

• 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.

  PMID: 27856392 BACKGROUND

• 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.

  PMID: 16716530 BACKGROUND

• 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.

  PMID: 24283327 BACKGROUND

• 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.

  PMID: 26300109 BACKGROUND

• 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.

  PMID: 27856393 BACKGROUND

• 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.

  PMID: 8255414 BACKGROUND

• 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.

  PMID: 25698987 BACKGROUND

• 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.

  PMID: 33004387 DERIVED

Related Links

• 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

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, saliva, hair

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Ximena Goldberg, PhD

CONTACT

+34 937240182; xlgoldberg@tauli.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 9, 2018
• Study Start: March 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

ES (1)