Neuropsychological Rehabilitation Program (VIRTRAEL/LUCCIDY)BELIEVE-CPTSDNCT06706882
The Role of Executive Functioning in Complex Post-Traumatic Stress Disorder Among Female Survivors of Intimate Partner Violence
A study testing Experimental Training: VIRTRAEL/LUCCIDY and Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010) in people with Neuropsychological Rehabilitation Program (VIRTRAEL/LUCCIDY) and Standard Training (TAU), run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neuropsychological Rehabilitation Program (VIRTRAEL/LUCCIDY), Standard Training (TAU)
- What is being tested?
- Experimental Training: VIRTRAEL/LUCCIDY and Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Mind, Brain and Behavior Research Center at University of Granada (CIMCYC-UGR)
Granada, Granada, 18071
About this study
Official title: The Role of Executive Functioning in Complex Post-Traumatic Stress Disorder Among Female Survivors of Intimate Partner Violence (BELIEVE-CPTSD)
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.
Read the 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:
- 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:
- 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.
- 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.
- Neuropsychological alterations in survivor women will be more closely related to specific symptoms of C-PTSD than those of PTSD.
- 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.
- Being tested
- Experimental Training: VIRTRAEL/LUCCIDY, Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010)
- Keywords
- Intimate partner violence, Posttraumatic Stress Disorder, Complex Postrraumatic Stress Disorder, Neuropsychological functioning
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Training: VIRTRAEL/LUCCIDYBehavioural
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.
Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Behavioral: Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Weeks 1, 14 and 27
Secondary outcomes (10)
Adverse childhood experiences
Adverse Childhood Experience (ACE). It is a screening tool designed to measure various types of adverse experiences that occur during childhood, such as abuse, neglect, and household dysfunction. The ACE questionnaire consists of 10 questions, each focusing on different types of adverse experiences before the age of 18. The total score, ranging from 0 to 10, indicates the level of exposure to childhood adversity, with higher scores being associated with greater health risks.
Measured: Weeks 1, 14 and 27
Depression
Patient Health Questionnaire (PHQ-9). It is a widely-used self-report tool for assessing depression severity. It consists of 9 items, each of which corresponds to one of the diagnostic criteria for major depressive disorder as outlined in the DSM-IV.
The PHQ-9 asks individuals to rate the frequency of symptoms such as low mood, loss of interest in activities, changes in sleep and appetite, concentration difficulties, feelings of worthlessness, and thoughts of self-harm over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms.
Scoring guidelines typically classify the severity of depression as:
0-4: Minimal or none 5-9: Mild 10-14: Moderate 15-19: Moderately severe 20-27: Severe
Measured: Weeks 1, 14 and 27
Anxiety
Generalized Anxiety Disorder Scale (GAD-7). It is a brief self-report tool designed to assess the severity of generalized anxiety disorder (GAD) and anxiety-related symptoms. It consists of 7 items that ask how often, over the last two weeks, the individual has experienced symptoms such as feeling nervous, inability to control worry, restlessness, irritability, and physical symptoms like tension or trouble relaxing.
Each item is scored from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 21. The higher the score, the more severe the anxiety:
0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety
Measured: Weeks 1, 14 and 27
Severity and intensity of Intimate partner 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. The response options are typically based on a frequency scale: 0 = never, 1 = once, 2 = a few times, and 3 = many times. To calculate the score, the responses for each dimension of violence are summed, allowing for a measure of the severity and frequency of the violence experienced.
Measured: Weeks 1, 14 y 27
Sociodemographic, clinical, and relationship variables
Measures regarding education and socioeconomic level, history of neuropsychological and psychopathological alterations (prior to abuse) that may affect neuropsychological performance (e.g., substance use, brain diseases, depression, etc.), characteristics of the abusive relationship, time elapsed from the onset of IPV until it was abandoned, among others.
Measured: Weeks 1, 14 and 27
Posttraumatic Stress Disorder
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. It consists of 20 items covering re-experiencing, avoidance, negative cognition/mood, and hyperarousal symptoms. Responses are rated on a 5-point Likert scale: 0 = Not at all; 1 = A little bit; 2 = Moderately; 3 = Quite a bit; 4 = Extremely The total score is calculated by summing the responses, ranging from 0 to 80, with higher scores indicating greater PTSD symptom severity. A score of 33 or higher is often used as a cut-off for a provisional PTSD diagnosis.
Measured: Weeks 1, 14 and 27
Exposure to traumatic life events
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. The ITEM measures exposure to 21 different traumatic life events across different developmental periods: childhood, adolescence, and adulthood.
Measured: Weeks 1, 14 and 27
Perceived Stress
Perceived Stress Scale (PSS). It is a tool designed to measure an individuals perception of stress. The PSS assesses perceived stress rather than actual stressors, giving insight into how people interpret and cope with stress in their lives.
The PSS consists of 10 items that ask about feelings and thoughts during the last month. Respondents rate each item on a 5-point scale ranging from 0 (never) to 4 (very often). Items cover experiences such as feeling nervous or stressed, being able to handle personal problems, and feeling confident about coping with difficulties.
The total score is calculated by reversing the scores on certain positive items and summing them up, with higher scores indicating higher levels of perceived stress.
Measured: Weeks 1, 14 and 27
Emotion Regulation
Emotion Regulation Questionnaire (ERQ). It is a self-report measure designed to assess individual differences in emotion regulation strategies, particularly focusing on cognitive reappraisal and expressive suppression.
The ERQ consists of 10 items, with participants rating how often they use these strategies on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). Six items assess cognitive reappraisal, and four items assess expressive suppression.
Measured: Weeks 1, 14 and 27
Alcohol Use Disorders
Alcohol Use Disorders Identification Test-Consumption (Audit-C) is a widely used screening tool to identify individuals with risky drinking behaviors and potential alcohol use disorders. the AUDIT-C consists of three questions that assess:
- Frequency of alcohol consumption (How often do you have a drink containing alcohol?),
- Quantity of alcohol consumed (How many drinks containing alcohol do you have on a typical day when you are drinking?),
- Frequency of binge drinking (How often do you have six or more drinks on one occasion?).
Each question is scored from 0 to 4, with the total score ranging from 0 to 12. Higher scores indicate a greater risk of hazardous drinking or alcohol use disorder. A score of 4 or more in men and 3 or more in women is typically considered positive for identifying hazardous drinking.
Measured: Weeks 1, 14 and 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Oct 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuropsychological Rehabilitation Program (VIRTRAEL/LUCCIDY)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Principal investigator, Natalia Hidalgo Ruzzante, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706882
- Sponsor's protocol ID
- PID2022-143060NB-I00
- Other IDs
- PID2022-143060NB-I00
- Acronym
- BELIEVE-CPTSD
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after the identification, will be shared. Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee and who provide a methodologically sound proposal. Proposals should be directed to nhidalgo@ugr.es
Publications
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
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.
PubMed 34211640Fernandez-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.
PubMed 34925711
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Executive Functioning in Complex Post-Traumatic Stress Disorder Among Female Survivors of Intimate Partner Violence (BELIEVE-CPTSD)
- ClinicalTrials.gov ID
- NCT06706882
- Acronym / sponsor ID
- BELIEVE-CPTSD / PID2022-143060NB-I00
- Keywords
- Intimate partner violence, Posttraumatic Stress Disorder, Complex Postrraumatic Stress Disorder, Neuropsychological functioning
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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.
- Neuropsychological alterations in survivor women will be more closely related to specific symptoms of C-PTSD than those of PTSD.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Training: VIRTRAEL/LUCCIDY | Experimental | Behavioral: Experimental Training: VIRTRAEL/LUCCIDYThe 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 |
| Standard Training: Reflection Group (TAU) | Active comparator | Behavioral: Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010)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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Training: VIRTRAEL/LUCCIDYCognitive 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. | Behavioural | Experimental Training: VIRTRAEL/LUCCIDY |
| 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. | Behavioural | Standard Training: Reflection Group (TAU) |
Primary outcome
Neuropsychological performance
Time frame: 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
Time frame: 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.
10 secondary outcomes
Adverse childhood experiences
Time frame: Weeks 1, 14 and 27
Depression
Time frame: Weeks 1, 14 and 27
Anxiety
Time frame: Weeks 1, 14 and 27
Severity and intensity of Intimate partner violence
Time frame: Weeks 1, 14 y 27
Sociodemographic, clinical, and relationship variables
Time frame: Weeks 1, 14 and 27
Posttraumatic Stress Disorder
Time frame: Weeks 1, 14 and 27
Exposure to traumatic life events
Time frame: Weeks 1, 14 and 27
Perceived Stress
Time frame: Weeks 1, 14 and 27
Emotion Regulation
Time frame: Weeks 1, 14 and 27
Alcohol Use Disorders
Time frame: Weeks 1, 14 and 27
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- BackgroundDaugherty, 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: PubMed 34211640Cloitre 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.
- Background: PubMed 34925711Fernandez-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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after the identification, will be shared. Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee and who provide a methodologically sound proposal. Proposals should be directed to nhidalgo@ugr.es
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Training: VIRTRAEL/LUCCIDY and Active Comparator: Standard Training: Reflection Group (TAU) (Andalusian Institute of Women, 2010) in people with Neuropsychological Rehabilitation Program (VIRTRAEL/LUCCIDY) and Standard Training (TAU), run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological performance (time frame: Weeks 2, 15 and 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06706882, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.