Depressive Disorder Clinical Trial
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
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.
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