The Role of Executive Functioning in Complex Post-Traumatic Stress Disorder Among Female Survivors of Intimate Partner Violence (BELIEVE-CPTSD)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Neuropsychological performance
研究概览
简要总结
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.
详细描述
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:
- 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).
- To analyze differences in neuropsychological alterations between Post-Traumatic Stress Disorder and Complex Post-Traumatic Stress Disorder.
- To implement a neuropsychological rehabilitation program (VIRTRAEL-LUCCIDY) in women survivors of IPV.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ability to read and write without difficulty.
- •For the IPV group, participants must have experienced some form of violence from their partner or ex-partner.
排除标准
- •Not having a history of brain damage prior to the abusive relationship
- •Not having illnesses prior to the abusive relationship that could affect cognition (e.g., lupus, multiple sclerosis...).
研究组 & 干预措施
Experimental Training: VIRTRAEL/LUCCIDY
The neuropsychological rehabilitation program VIRTRAEL/LUCCIDY is designed for cognitive assessment and stimulation, shown to improve verbal learning, memory, attention, reasoning, and planning. It consists of 11 exercises over 9 sessions, each lasting 60 minutes. The platform adapts the difficulty of exercises based on performance through an algorithm, focusing on cognitive functions like attention, memory, and planning. To maintain motivation, the program includes varied exercises, avatars, and rewards. The exercises are ecologically designed to simulate daily activities for real-life application. Sessions involve tasks like shopping lists, puzzles, and memory challenges. Link: http://www.everyware.es/webs/virtrael/#home
干预措施: Experimental Training: VIRTRAEL/LUCCIDY (Behavioral)
Standard Training: Reflection Group (TAU)
It is a group work offered to survivor women of IPV in municipal and provincial centers (CIMs) of the Women's Institute. The objective of this intervention is to provide women with a space for group reflection, as well as a series of skills and tools. Concrete topics are presented, including those related to intervention in crisis situations from a gender perspective. It lasts for 9 sessions (60 minutes per session) with a frequency of one session per week.
The sessions cover themes such as the idealization of women as caregivers (Session 1), gender conflicts (Session 2), guilt when deviating from gender expectations (Session 3), dependence on others for self-worth (Session 4), and romantic love as a tool to fulfill men's needs over women's (Session 5). They explore intimate partner violence (IPV) as a conflict strategy (Session 6), family's role in socialization (Session 7), fears of abandonment (Session 8), and life skills for independence (Session 9).
干预措施: Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010) (Behavioral)
结局指标
主要结局
Neuropsychological performance
时间窗: Weeks 2, 15 and 28
BELIEVE Battery is a computerized battery administered through a tablet that evaluates different cognitive functions: Cancellation measures selective attention; Colored Words assesses flexibility and inhibition; Coin in Hand tests memory under distraction; Visomotor and Alternate Visomotor evaluate processing speed and motor skills; Matrices measures abstract reasoning; Multitasking tests multitasking ability; Working Memory assesses memory with numbers and colors; Verbal Memory tests recall; Verbal Comprehension evaluates instruction understanding; Finger Tapping measures motor speed; Marking, Tracing, Dotting evaluate visuomotor coordination; Complex Figure Copy tests visual memory; Naming tests verbal identification; Fluency tests word generation; Orientation measures awareness; Clock Drawing tests visuoconstruction; Continuous Performance measures attention; Eyes tests emotion recognition; Simple Reaction Time measures motor speed.
Posttraumatic Stress Disorder and Complex-Posttraumatic Stress Disorder
时间窗: Weeks 1, 14 and 27
The International Trauma Questionnaire (ITQ) is a tool designed to assess the symptoms of Post-Traumatic Stress Disorder (PTSD) and Complex PTSD as outlined by the International Classification of Diseases. Each symptom is rated on a scale from 0 to 4, where: 0 = Not at all; 1 = A little bit; 2 = Moderately; 3 = Quite a bit;4 = Extremely. For PTSD, the questionnaire focuses on three core clusters: Re-experiencing the trauma, Avoidance of trauma-related stimuli and Persistent sense of threat or hypervigilance. For CPTSD, additional domains are assessed: Affective dysregulation, Negative self-concept and Interpersonal difficulties. To meet the criteria for PTSD, the respondent must score at least 2 (moderately) on one symptom from each of the PTSD clusters. To meet the criteria for CPTSD, the same PTSD criteria must be met, plus a score of at least 2 on one symptom from each of the disturbances in self-organization (DSO) clusters.
次要结局
- Adverse childhood experiences(Weeks 1, 14 and 27)
- Sociodemographic, clinical, and relationship variables(Weeks 1, 14 and 27)
- Depression(Weeks 1, 14 and 27)
- Anxiety(Weeks 1, 14 and 27)
- Severity and intensity of Intimate partner violence(Weeks 1, 14 y 27)
- Posttraumatic Stress Disorder(Weeks 1, 14 and 27)
- Exposure to traumatic life events(Weeks 1, 14 and 27)
- Perceived Stress(Weeks 1, 14 and 27)
- Emotion Regulation(Weeks 1, 14 and 27)
- Alcohol Use Disorders(Weeks 1, 14 and 27)
研究者
Natalia Hidalgo Ruzzante
Principal investigator
Universidad de Granada