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Borderline Personality DisorderNCT03932656

Latent Toxoplasmosis in Females With Borderline Personality Disorder

An observational study of Borderline Personality Disorder and Toxoplasmosis, run by Marie Ociskova at 1 site in Czechia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Combined schema-therapy and cognitive behavioral therapy and Psychopharmaceuticals
How many people
0 participants
Where
1 siteCzechia
Study dates
1 Jan 2021to 1 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • Department of Psychiatry, Palacky University, University Hospital Olomouc

    Olomouc, 77900

Other trials in Czechia

About this study

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

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.

Being tested
Combined schema-therapy and cognitive behavioral therapy, Psychopharmaceuticals
Keywords
borderline personality disorder, latent toxoplasmosis, Toxoplasma gondii, pharmacotherapy, psychotherapy, clinical features
Medical subject headings
Borderline Personality Disorder, Toxoplasmosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined schema-therapy and cognitive behavioral therapyBehavioural

    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.

  • PsychopharmaceuticalsDrug

    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.

Study groups in NCT03932656
Study groupRoleWhat they receive
Females with borderline personality disorderNot described
Receives: Behavioral: Combined schema-therapy and cognitive behavioral therapy; Drug: Psychopharmaceuticals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 day

  2. 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.

    Measured: 1 day

  3. 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.

    Measured: 1 day

  4. 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.

    Measured: 1 year

Secondary outcomes (7)
  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. 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.

    Measured: 1 year

  6. 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.

    Measured: 1 year

  7. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start1 Jan 2021
  3. Primary completion1 Nov 2023
  4. Study completion1 Apr 2024

Why it stopped: Funding issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03932656
Sponsor's protocol ID
NV19-05-00105
Status last verified
Apr 2024
First submitted
22 Apr 2019
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19538082
  • 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.

    PubMed 17592784
  • 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.

    PubMed 1403624
  • 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.

    PubMed 11785588
  • 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.

    PubMed 3204199
  • 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.

    PubMed 8991972
  • 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.

    PubMed 3783140
  • 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.

    PubMed 8037246
  • 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.

    PubMed 14572622
  • Parker G, Tupling H, Brown LB. A Parental Bonding Instrument. British Journal of Medical Psychology 52: 1-10, 1979.

  • 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.

  • 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.

    PubMed 10707340
  • Sheehan DV. The Anxiety Disease. New York: Scribner's; 1983.

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Borderline Personality Disorder and Toxoplasmosis, run by Marie Ociskova at 1 site in Czechia.

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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 2 Apr 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 Czechia. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Immunoglobulin A detection in human serum (time frame: 1 day). The study lists 4 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 NCT03932656, which also lists 14 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 2 Apr 2024.

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