Latent Toxoplasmosis in Females With Borderline Personality Disorder

Study Overview
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Brief Summary
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Borderline personality disorder is a common mental disorder with core features of affective dysregulation, impulsivity, and identity disturbance. Although this disorder is mostly understood as a result of a combination of biological factors (genes, temperament) and early aversive experiences (often of traumatic nature), recent data suggest that other factors may be important in its development and course. Preliminary findings show that patients with borderline personality disorder have higher prevalence of Toxoplasma seropositivity. This infection may manifest in symptoms such as affective dysregulation, aggression, suicidality, or anxiousness. As such, it may play a role in the psychopathology of the borderline personality disorder. The aim of this study is to explore the prevalence of Toxoplasma seropositivity in a sample of females with borderline personality disorder, its clinical correlates, and a potential impact on outcomes of an intensive six-week inpatient schema-therapeutic treatment. Results may enrich our understanding of this disorder and lead to improvements of the therapeutic approaches.

Official Title
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Latent Toxoplasmosis in Females With Borderline Personality Disorder - Occurrence, Clinical Features, and Impact on Effectiveness of Combined Pharmacotherapeutic and Psychotherapeutic Treatment

Conditions
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Borderline Personality Disorder, Toxoplasmosis

Intervention / Treatment
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* Behavioral: Combined schema-therapy and cognitive behavioral therapy
* Drug: Psychopharmaceuticals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Female Borderline personality disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders-5 criteria Signed informed consent Exclusion Criteria: Current substance abuse disorder Psychotic disorder, bipolar disorder, organic mental disorder current or past Severe suicidal risk Severe somatic illness (e.g., endocrinopathy, oncologic, hematologic, cardiologic, or neurologic illness)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Females with borderline personality disorder<br> | Behavioral: Combined schema-therapy and cognitive behavioral therapy<br>* A six-week inpatient psychotherapeutic program consisting of one small group and one big group therapy per day, one individual session per week, daily sport activities, imagery and relaxation techniques. The therapeutic approach presents a combination of schema-therapy and cognitive behavioral therapy. Schema-therapy will follow guidelines for the treatment of individuals with borderline personality disorder (Farrell and Shaw 2012). A later step in the therapy - strengthening of the called Healthy Adult (that is the ability to perceive situations realistically, think rationally, plan time, set appropriate goals, or behave assertively) will be done by standard cognitive behavioral strategies (cognitive restructuring, core beliefs work, time planning, problem solving, assertiveness training). A detailed description of the program is going to be published in a paper.<br>Drug: Psychopharmaceuticals<br>* Pharmacotherapy will be implemented according to the National Institute for Health and Care Excellence guidelines and will target comorbidities if present to such extent that warrants a pharmacological intervention. If not needed, patients will not use medication. Most patients will be recommended to hospitalization by their outpatient psychiatrists who prescribe the medication. If needed, medication will be changed to meet the guideline standards (i.e., tapering off benzodiazepines or augmentation with a mood stabilizer). The medication will be controlled but not directed by the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunoglobulin A detection in human serum | ELISA detection of immunoglobulin A specific antibodies - a sensitive and specific marker of acute infection. Index of positivity is higher than 1,1. | 1 day | 
| Immunoglobulin M detection in human serum | ELISA detection of immunoglobulin M specific antibodies - a highly sensitive marker of acute infection. Index of positivity is higher than 1,1. | 1 day | 
| Immunoglobulin G detection in human serum | ELISA detection of immunoglobulin G specific antibodies - a marker of undergone infection. The cut-off score for positivity is set at higher than 6,6 IU/ml. | 1 day | 
| Severity of borderline personality symptoms | Assessed by modified Clinical Global Impression for borderline personality disorder which was developed by Pérez et al (2007). This rating scale measures severity of the nine diagnostic criteria of the disorder, along with its overall severity. In each item, a clinician chooses one number of a seven-point scale where 1 = normal, not at all ill and 7 = among the most extremely ill subjects. The scores in the items are not summed. Instead, each of the item enters statistical analyses separately. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borderline Evaluation of Severity over Time | This self-rating scale evaluates common symptoms of borderline personality disorder during a specified time range (7 days, 30 days, or other) (Pfohl et al. 2009). 15 items divide into three subscales - thoughts and feelings, behaviors (negative), and behaviors (positive). The patient responds to each item on a 5-point scale according to how much the symptom caused her distress, relationship issues, or disability (in the thoughts and feelings and negative behaviors subscales) and how often she engaged in positive behaviors. The total score ranges between 12 and 72, with higher scores indicating more severe symptomatology. | 1 year | 
| Aggression Questionnaire | The questionnaire, created by Buss and Perry (1992), has 29 items that are divided into four factors - physical aggression, verbal aggression, anger, and hostility. The patient chooses a number from a five-point scale according to how much is each statement characteristic of her. The total score varies from 29 to 145; higher scores indicating more pronounced aggressive tendencies. | 1 year | 
| Suicide Behaviors Questionnaire-Revised | The questionnaire has four items that evaluate suicidality - a lifetime frequency of suicide ideation and/or attempt, a frequency of suicidal ideation in the last 12 months, a frequency of threats of suicide attempt, and self-reported likelihood of suicidal behavior in the future (Osman et al. 1999). The total score ranges from 3 to 18; higher scores indicate more severe suicidality. | 1 year | 
| Beck Anxiety Inventory | The self-rating inventory measures 21 symptoms of anxiety in the time span of a week (Beck et al. 1988). The patient evaluates each symptom with a four-point scale where higher scores mean more severe symptomatology. The total score varies from 0 to 63 points. | 1 year | 
| Beck Depression Inventory-II | The self-rating inventory measures 21 symptoms of depression during the last two weeks (Beck et al. 1996). The patient chooses perceived severity of each symptom. The total score can reach 0 to 63 points, higher scores representing more severe depressive symptomatology. | 1 year | 
| Dissociative Experiences Scale | The scale focuses on 28 dissociative symptoms that include dissociative amnesia, depersonalization, derealization, and absorption (Bernstein and Putnam 1986). The patient marks a spot on a 10-cm scale according to how often she perceives the symptom. The total score ranges from 0 to 100 - this number denotes how much time the individual spends in dissociative states. | 1 year | 
| Sheehan Disability Scale | The scale assesses the level of functional impairment in three areas - work/school, social, and family life (Sheehan 1983). The patient chooses a number from 0 to 10 according to how much her mental disorder disrupted her functioning in each area. The total score then ranges from 0 to 30, higher scores meaning larger disability. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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borderline personality disorder, latent toxoplasmosis, Toxoplasma gondii, pharmacotherapy, psychotherapy, clinical features