Latent Toxoplasmosis in Females With Borderline Personality Disorder

NCT03932656 | Withdrawn

• 1 other identifier: NV19-05-00105
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Borderline Personality Disorder; Toxoplasmosis

Keywords

borderline personality disorder; latent toxoplasmosis; Toxoplasma gondii; pharmacotherapy; psychotherapy; clinical features

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Borderline Evaluation of Severity over Time

  1 year

• Aggression Questionnaire

  1 year

• Suicide Behaviors Questionnaire-Revised

  1 year

• Beck Anxiety Inventory

  1 year

• Beck Depression Inventory-II

  1 year

Other Outcomes (4)

• Childhood Trauma Questionnaire

  1 day

• Parental Bonding Instrument Questionnaire

  1 day

• Internalized Stigma of Mental Illness Scale

  1 day

Study Arms (1)

Females with borderline personality disorder

Behavioral: Combined schema-therapy and cognitive behavioral therapy; Drug: Psychopharmaceuticals

Interventions

Combined schema-therapy and cognitive behavioral therapy BEHAVIORAL

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.

Females with borderline personality disorder

Psychopharmaceuticals DRUG

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.

Females with borderline personality disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with borderline personality disorder who will be hospitalized at the psychotherapeutic ward of the university hospital.

You may qualify if:

• Adult
• Female
• Borderline personality disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders-5 criteria
• Signed informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Marie Ociskova: lead
• Palacky University: collaborator
• University Hospital Olomouc: collaborator

Study Sites (1)

Department of Psychiatry, Palacky University, University Hospital Olomouc

Olomouc, 77900, Czechia

Location

Related Publications (14)

• Pfohl B, Blum N, St John D, McCormick B, Allen J, Black DW. Reliability and validity of the Borderline Evaluation of Severity Over Time (BEST): a self-rated scale to measure severity and change in persons with borderline personality disorder. J Pers Disord. 2009 Jun;23(3):281-93. doi: 10.1521/pedi.2009.23.3.281.

  PMID: 19538082 BACKGROUND

• Perez V, Barrachina J, Soler J, Pascual JC, Campins MJ, Puigdemont D, Alvarez E. The clinical global impression scale for borderline personality disorder patients (CGI-BPD): a scale sensible to detect changes. Actas Esp Psiquiatr. 2007 Jul-Aug;35(4):229-35.

  PMID: 17592784 BACKGROUND

• Buss AH, Perry M. The aggression questionnaire. J Pers Soc Psychol. 1992 Sep;63(3):452-9. doi: 10.1037//0022-3514.63.3.452.

  PMID: 1403624 BACKGROUND

• Osman A, Bagge CL, Gutierrez PM, Konick LC, Kopper BA, Barrios FX. The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment. 2001 Dec;8(4):443-54. doi: 10.1177/107319110100800409.

  PMID: 11785588 BACKGROUND

• Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

  PMID: 3204199 BACKGROUND

• Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.

  PMID: 8991972 BACKGROUND

• Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986 Dec;174(12):727-35. doi: 10.1097/00005053-198612000-00004.

  PMID: 3783140 BACKGROUND

• Bernstein DP, Fink L, Handelsman L, Foote J, Lovejoy M, Wenzel K, Sapareto E, Ruggiero J. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry. 1994 Aug;151(8):1132-6. doi: 10.1176/ajp.151.8.1132.

  PMID: 8037246 BACKGROUND

• Ritsher JB, Otilingam PG, Grajales M. Internalized stigma of mental illness: psychometric properties of a new measure. Psychiatry Res. 2003 Nov 1;121(1):31-49. doi: 10.1016/j.psychres.2003.08.008.

  PMID: 14572622 BACKGROUND

• Parker G, Tupling H, Brown LB. A Parental Bonding Instrument. British Journal of Medical Psychology 52: 1-10, 1979.

  BACKGROUND

• Brennan KA, Clark CL, Shaver PR. Self-report measurement of adult attachment: An integrative overview. In Simpson JA & Rholes WS (Eds.), Attachment theory and close relationships (pp. 46-76). New York: Guilford Press; 1998.

  BACKGROUND

• Fraley RC, Waller NG, Brennan KA. An item response theory analysis of self-report measures of adult attachment. J Pers Soc Psychol. 2000 Feb;78(2):350-65. doi: 10.1037//0022-3514.78.2.350.

  PMID: 10707340 BACKGROUND

• Sheehan DV. The Anxiety Disease. New York: Scribner's; 1983.

  BACKGROUND

• Farrell JM, Shaw IA. Group schema therapy for borderline personality disorder: A step-by-step treatment manual with patient workbook. First edition. Chichester, United Kingdom: John Wiley & Sons Ltd; 2012.

  BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder; Toxoplasmosis

Interventions

Cognitive Behavioral Therapy; Psychotropic Drugs

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Coccidiosis; Protozoan Infections; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Marie Ociskova, PhD

  University Hospital Olomouc, Faculty of Medicine, Palacky University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 1, 2019
• Study Start: January 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: April 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

CZ (1)