NCT06706882

The Role of Executive Functioning in Complex Post-Traumatic Stress Disorder Among Female Survivors of Intimate Partner Violence

The Role of Executive Functioning in Complex Post-Traumatic Stress Disorder Among Female Survivors of Intimate Partner Violence (BELIEVE-CPTSD)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This project aims to investigate neuropsychological alterations in women with PTSD (Post-Traumatic Stress Disorder) and complex PTSD (CPTSD), survivors of intimate partner violence (IPV), and to implement a cognitive stimulation program. The specific objectives are: * To establish the prevalence and severity of neuropsychological alterations in women victims of IPV and to define their profile according to the type of violence suffered. * To analyze the differences in neuropsychological alterations between PTSD and CPTSD. * To implement a cognitive stimulation program in women with CPTSD. * To evaluate whether this program reduces symptoms of DSO (Disorders of Extreme Stress Not Otherwise Specified) and classic post-traumatic symptoms. * The hypotheses suggest that women victims of IPV will present lower scores in executive functions, attention, and memory, a higher prevalence of CPTSD, and that the cognitive stimulation program will improve complex post-traumatic sequelae. Methodology: Women victims of IPV attended at the CIMs of Andalusia will be randomly selected, with support from with support from the Andalusian Women Institute. Participants: 100 women victims of IPV and 100 non-victims. Inclusion criteria are literacy and, for IPV, having experienced partner violence. Those with a history of brain damage, previous psychopathological alterations, or diseases affecting cognition will be excluded. Evaluation: It will include sociodemographic surveys, violence assessment, psychopathological alterations, DSO symptoms, and neuropsychological assessments. Intervention: A cognitive stimulation program (VIRTRAEL/LUCCIDY) and a standard training (Reflection Group; TAU) in groups. Nine weekly sessions will be conducted, evaluating pre- and post-treatment and follow-up at 3 months.

Detailed description

STARTING HYPOTHESIS AND OBJECTIVES We hypothesize that women who have experienced IPV will demonstrate lower scores on standardized neuropsychological tests, particularly in executive functions, attention, and memory, as well as a higher prevalence of a diagnosis of C-PTSD (Complex Post-Traumatic Stress Disorder) compared to non-victimized women. Furthermore, these neuropsychological alterations are expected to be more closely associated with specific symptoms of C-PTSD than with those of PTSD. Therefore, we hypothesize that the implementation of a cognitive stimulation program will more effectively improve complex post-traumatic sequelae than classic symptoms. General Objective: The general objective of this project is to study the mediating role of neuropsychological alterations in PTSD and C-PTSD (according to ICD-11 diagnostic criteria) in women survivors of IPV and to implement a neuropsychological rehabilitation program. Specific Objectives: 1. To establish the prevalence and severity of alterations in neuropsychological functioning in women survivor of IPV, as well as to define the profile of neuropsychological sequelae, and differentiate it according to the type of violence experienced (psychological, physical, and sexual). 2. To analyze differences in neuropsychological alterations between Post-Traumatic Stress Disorder and Complex Post-Traumatic Stress Disorder. 3. To implement a neuropsychological rehabilitation program (VIRTRAEL-LUCCIDY) in women survivors of IPV. 4. To examine whether the application of a neuropsychological rehabilitation program reduces DSO symptoms (negative self-concept, difficulties in emotional regulation, and difficulties in interpersonal relationships) in survivor women, as well as classic Post-Traumatic Symptoms. Specific Hypotheses: 1. Women who have experienced IPV will demonstrate lower scores on standardized neuropsychological tests, particularly in executive functions, attention, and memory, compared to non-victimized women. 2. Women victims of IPV will exhibit symptoms of PTSD as indicated by the literature, but will also manifest symptoms of Complex PTSD. There will be a higher prevalence of C-PTSD than PTSD. 3. Neuropsychological alterations in survivor women will be more closely related to specific symptoms of C-PTSD than those of PTSD. 4. The implementation of a neuropsychological rehabilitation program will more effectively improve complex post-traumatic sequelae than classic symptoms. METHODOLOGY Design: Randomized controlled trial of parallel groups. Participants: Participants: Participants (objectives 1 and 2): A total of 100 women victims of IPV (VG group) and 100 non-victimized women (NVG group) aged between 18 and 50 years will be evaluated to avoid age-related deterioration. The women victims included in this study will be randomly selected from the CIMs (Centros de Información a la Mujer) of Andalusia. All participants will sign an informed consent form previously approved by the Committee Ethics Research (CEI Provincial de Granada - A01037775). Participants (objectives 3 and 4): The sample will consist of 80 women surivvor of IPV. Among them, 40 will receive neuropsychological rehabilitation program (VIRTRAEL/LUCCIDY) and 40 will receive a standard training for the care of survivor women (TAU), all of the same duration. They will be divided into intervention groups of approximately 6-8 participants (VIRTRAEL/LUCCIDY and TAU). These women will be randomly selected from various CIMs (municipal and provincial) in Andalusia. Inclusion and exclusion criteria will be the same as for the group of survivor women in objectives 1 and 2. Instruments Module I: Sociodemographic, clinical, and relationship survey: * Measures regarding education and socioeconomic level, history of neuropsychological and psychopathological alterations (prior to abuse) that may affect neuropsychological performance (e.g., substance use, medication use, brain diseases, depression, etc.), characteristics of the abusive relationship, time elapsed from the onset of IPV until it was abandoned, among others. * Alcohol Use Disorders Identification Test-Consumption (Audit-C). Module II: Variables related to violence: * World Health Organization violence against women instrument. It is a self-reported questionnaire that assesses the dimensions of physical, sexual, psychological, and, in some versions, economic violence experienced by a woman in the context of Intimate partner violence. * Adverse Childhood Experiences (ACE). Evaluates exposure to adverse experiences in childhood, including verbal abuse, physical abuse, sexual abuse, among others. * The International Trauma Exposure Measure (ITEM) is a checklist developed to measure exposure to traumatic life events in a manner consistent with the definition of trauma exposure in the 11th version of the International Classification of Diseases. Module III: Psychopathological alterations: * International Trauma Questionnaire (ITQ). Brief self-report measure freely available internationally developed in coherence with ICD-11 criteria (WHO, 2018). It particularly focuses on defining functional impairment for both PTSD and C-PTSD. * Patient Health Questionnaire (PHQ-9). Evaluates depression through items associated with DSM and ICD criteria. Part of the Patient Health Questionnaire from the National Institutes of Health (NIH). * Generalized Anxiety Disorder Scale (GAD-7). Screens for generalized anxiety. It has shown solid psychometric properties in the Spanish population, as well as in survivor women of IPV. * Perceived Stress Scale (PSS). Evaluates perceived stress level and the degree to which individuals find their life unpredictable, uncontrollable, overloaded. * Emotion Regulation Questionnaire (ERQ). Assesses tendency to regulate emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. * Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). It is a self-report questionnaire used to assess PTSD symptoms based on DSM-5 criteria. Module IV: Neuropsychological assessment: -BELIEVE Battery. (http://projectbelieve.info). BELIEVE Battery is a free, online and comprehensive neuropsychological battery specifically developed for women victims and survivors of IPV. The Believe Battery includes evidence-based measures for neuropsychological functioning, which were based on the EMBRACED Project. The cognitive domains assessed by this battery include memory, executive function, attention, language, motor and visuospatial abilities, perception, orientation, and social cognition. Procedure (objectives 3 and 4): Women will be selected from the population served by different CIMs (Centros de Información a la Mujer) in Andalusia. They will receive detailed information from the research team about the study objectives, as well as the general characteristics of the intervention. The intervention (VIRTRAEL/LUCCIDY and TAU) will consist of 9 sessions, with a weekly frequency, and in a group format. A psychopathological, DSO, neuropsychological, and previous violence assessment will be conducted (pre and post-treatment and follow-up at 3 months). The final protocol will adhere to CONSORT criteria, specifically to the recommendations of these criteria for the application to clinical trials of psychological treatments, as well as SPIRIT criteria and its specifications for the consideration of participant self-reported outcomes.

Conditions

• Neuropsychological Rehabilitation Program (VIRTRAEL/LUCCIDY)
• Standard Training (TAU)

Interventions

Type	Name	Description
BEHAVIORAL	Experimental Training: VIRTRAEL/LUCCIDY	Cognitive stimulation of the different cognitive functions to be addressed will be conducted in the following sessions: * Session 1: Shopping lists. Balls. Gift shopping. Long-term memory of the Shopping List. * Session 2: Disordered objects. Whats different? Semantic series. Logical series. Puzzle pieces. Semantic analogies. * Session 3: Classifiable objects. Gift shopping. Bag of objects. * Session 4: Shopping lists. Balls. Disordered objects. Long-term memory of the Shopping List. * Session 5: Semantic series. Logical series. Puzzle pieces. Semantic analogies. Gift shopping. * Session 6: Classifiable objects. Bag of objects. Disordered objects. * Session 7: Shopping lists. Semantic series. Logical series. Puzzle pieces. What\'s different? Semantic analogies. Long-term memory of the Shopping List. * Session 8: Disordered objects. Gift shopping. Balls. * Session 9: Bag of objects. Semantic series. Logical series. Whats different? Semantic analogies. Classifiable objects.
BEHAVIORAL	Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010)	This 9-session program explores how societal norms shape women\'s roles and identities. In Session 1, it discusses how women are socially positioned as caretakers in relationships and introduces the concept of the self in relation. Session 2 delves into gender conflicts, focusing on the tension between societal demands and personal desires. Session 3 explores guilt when women fail to meet expected roles, and the fear of being selfish when prioritizing their own needs. Session 4 examines how dependence is fostered by seeking external validation for self-worth. Session 5 critiques romantic love as a cultural tool to prioritize men desires over women. Session 6 analyzes how intimate partner violence (IPV) emerges as a means to maintain power imbalances in relationships. Session 7 looks at the family role in socializing women, while Session 8 explores fears of abandonment. Finally, Session 9 focuses on building life skills and concludes the program.

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2024-11-27
• Last updated: 2024-12-03

Locations

1 site across 1 country: Spain