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

NCT06706882 | Enrolling By Invitation

• 1 other identifier: PID2022-143060NB-I00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intimate partner violence; Posttraumatic Stress Disorder; Complex Postrraumatic Stress Disorder; Neuropsychological functioning

Outcome Measures

Primary Outcomes (2)

• Neuropsychological performance

  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.

  Weeks 2, 15 and 28

• Posttraumatic Stress Disorder and Complex-Posttraumatic Stress Disorder

  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.

  Weeks 1, 14 and 27

Secondary Outcomes (10)

• Adverse childhood experiences

  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

• Sociodemographic, clinical, and relationship variables

  Weeks 1, 14 and 27

Study Arms (2)

Experimental Training: VIRTRAEL/LUCCIDY

EXPERIMENTAL

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

Behavioral: Experimental Training: VIRTRAEL/LUCCIDY

Standard Training: Reflection Group (TAU)

ACTIVE COMPARATOR

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).

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

Interventions

Experimental Training: VIRTRAEL/LUCCIDY BEHAVIORAL

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.

Experimental Training: VIRTRAEL/LUCCIDY

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

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.

Standard Training: Reflection Group (TAU)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: According to the current legislative framework in Spain, specifically Organic Law 1/2004 on Comprehensive Protection Measures against Gender Violence. This law focuses on violence occurring within the context of intimate partner or ex-partner relationships, where women are the victims of male aggressors. However, it is important to highlight that the circumstances and experiences of cisgender women and other women (such as trans women, non-binary individuals, or those of other gender identities) can differ significantly. These differences in the experience of violence and discrimination deserve to be studied separately, as they uniquely affect each group. For example, trans women often face additional barriers in accessing resources and protection, emphasizing the need for an intersectional perspective that addresses the various forms of violence and discrimination experienced by all women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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...).

Sponsors & Collaborators

• Universidad de Granada: lead
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (1)

Mind, Brain and Behavior Research Center at University of Granada (CIMCYC-UGR)

Granada, Granada, 18071, Spain

Location

Related Publications (3)

• 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

  BACKGROUND

• 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.

  PMID: 34211640 BACKGROUND

• 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.

  PMID: 34925711 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallel group randomized controlled trial

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 27, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: October 2024-June 2027

Locations

ES (1)