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

University of Granada (UGR)

Status: Invitation-only

Conditions: Standard Training (TAU); Neuropsychological Rehabilitation Program (VIRTRAEL/LUCCIDY)

Treatments: Behavioral: Experimental Training: VIRTRAEL/LUCCIDY; Behavioral: Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010)

Study type: Interventional

Funder types: Other

Identifiers

NCT06706882

PID2022-143060NB-I00 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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...).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Experimental Training: VIRTRAEL/LUCCIDY

Experimental group

Description:

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

Treatment:

Behavioral: Experimental Training: VIRTRAEL/LUCCIDY

Standard Training: Reflection Group (TAU)

Active Comparator group

Description:

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).

Treatment:

Behavioral: Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010)