Clinical trial NCT06706882: The Role of Executive Functioning in Complex Post-Traumatic Stress Disorder Among Female Survivors of Intimate Partner Violence
Official title: The Role of Executive Functioning in Complex Post-Traumatic Stress Disorder Among Female Survivors of Intimate Partner Violence (BELIEVE-CPTSD)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Neuropsychological Rehabilitation Program (VIRTRAEL/LUCCIDY)
Standard Training (TAU)
Keywords: Intimate partner violence
Posttraumatic Stress Disorder
Complex Postrraumatic Stress Disorder
Neuropsychological functioning
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2024-11-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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...).

Primary outcomes:
measure: Neuropsychological performance
timeFrame: Weeks 2, 15 and 28
measure: Posttraumatic Stress Disorder and Complex-Posttraumatic Stress Disorder
timeFrame: Weeks 1, 14 and 27
Secondary outcomes:
measure: Adverse childhood experiences
timeFrame: Weeks 1, 14 and 27
measure: Depression
timeFrame: Weeks 1, 14 and 27
measure: Anxiety
timeFrame: Weeks 1, 14 and 27
measure: Severity and intensity of Intimate partner violence
timeFrame: Weeks 1, 14 y 27
measure: Sociodemographic, clinical, and relationship variables
timeFrame: Weeks 1, 14 and 27
measure: Posttraumatic Stress Disorder
timeFrame: Weeks 1, 14 and 27
measure: Exposure to traumatic life events
timeFrame: Weeks 1, 14 and 27
measure: Perceived Stress
timeFrame: Weeks 1, 14 and 27
measure: Emotion Regulation
timeFrame: Weeks 1, 14 and 27
measure: Alcohol Use Disorders
timeFrame: Weeks 1, 14 and 27
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Mind, Brain and Behavior Research Center at University of Granada (CIMCYC-UGR)
Study officials:
References:
citation: Daugherty, J. C., Marañón-Murcia, M., Hidalgo-Ruzzante, N., Bueso-Izquierdo, N., Jiménez-González, P., Gómez-Medialdea, P., & Pérez-García, M. (2018). Severity of neurocognitive impairment in women who have experienced intimate partner violence in Spain. The Journal of Forensic Psychiatry & Psychology, 30(2), 322-340
citation: Cloitre M, Hyland P, Prins A, Shevlin M. The international trauma questionnaire (ITQ) measures reliable and clinically significant treatment-related change in PTSD and complex PTSD. Eur J Psychotraumatol. 2021 Jun 22;12(1):1930961. doi: 10.1080/20008198.2021.1930961.
citation: Fernandez-Fillol C, Pitsiakou C, Perez-Garcia M, Teva I, Hidalgo-Ruzzante N. Complex PTSD in survivors of intimate partner violence: risk factors related to symptoms and diagnoses. Eur J Psychotraumatol. 2021 Dec 16;12(1):2003616. doi: 10.1080/20008198.2021.2003616. eCollection 2021.