Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 63 of 610 for:    Personality Disorders

Latent Toxoplasmosis in Females With Borderline Personality Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03932656
Recruitment Status : Not yet recruiting
First Posted : May 1, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
Palacky University
University Hospital Olomouc
Information provided by (Responsible Party):
Marie Ociskova, Palacky University

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.

Condition or disease Intervention/treatment
Borderline Personality Disorder Toxoplasmosis Behavioral: Combined schema-therapy and cognitive behavioral therapy Drug: Psychopharmaceuticals

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Latent Toxoplasmosis in Females With Borderline Personality Disorder - Occurrence, Clinical Features, and Impact on Effectiveness of Combined Pharmacotherapeutic and Psychotherapeutic Treatment
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Females with borderline personality disorder Behavioral: Combined schema-therapy and cognitive behavioral therapy
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.

Drug: Psychopharmaceuticals
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.




Primary Outcome Measures :
  1. Immunoglobulin A detection in human serum [ Time Frame: 1 day ]
    ELISA detection of immunoglobulin A specific antibodies - a sensitive and specific marker of acute infection. Index of positivity is higher than 1,1.

  2. Immunoglobulin M detection in human serum [ Time Frame: 1 day ]
    ELISA detection of immunoglobulin M specific antibodies - a highly sensitive marker of acute infection. Index of positivity is higher than 1,1.

  3. Immunoglobulin G detection in human serum [ Time Frame: 1 day ]
    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.

  4. Avidity of immunoglobulin G detection in human serum [ Time Frame: 1 day ]
    In positive samples, the assessment of the avidity can roughly show how long the patient has been exposed to the infection. The avidity then can be interpreted as low (lower than 31 percent; 4 months since getting infected), borderline (31-36 percent), and high (higher than 36 percent; more than four months since getting infected).

  5. Severity of borderline personality symptoms [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Borderline Evaluation of Severity over Time [ Time Frame: 1 year ]
    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.

  2. Aggression Questionnaire [ Time Frame: 1 year ]
    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.

  3. Suicide Behaviors Questionnaire-Revised [ Time Frame: 1 year ]
    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.

  4. Beck Anxiety Inventory [ Time Frame: 1 year ]
    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.

  5. Beck Depression Inventory-II [ Time Frame: 1 year ]
    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.

  6. Dissociative Experiences Scale [ Time Frame: 1 year ]
    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.

  7. Sheehan Disability Scale [ Time Frame: 1 year ]
    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.


Other Outcome Measures:
  1. Childhood Trauma Questionnaire [ Time Frame: 1 day ]
    The questionnaire was created by Bernstein et al. (1994) as a screening for history of child abuse and neglect. It consists of 28 items divided into five factors - emotional, sexual, and physical abuse and emotional and physical neglect. In each item, the patient states how often she experienced described situation on a five-point scale (1 = never, 5 = very often). A total score of each subscale is then calculated; higher scores mean more aversive experiences in childhood.

  2. Parental Bonding Instrument Questionnaire [ Time Frame: 1 day ]
    The questionnaire retrospectively evaluates parental attachment (separately for each parent) up to 16 years of age (Parker 1979). It consists of 25 items divided into two subscales - care and overprotection. The patients evaluates each item on a four-point scale according to how much she finds the statement fitting to her parents. The results are separate for the parents. Each of them get two scores - one for care and one for overprotection. The lowest score of the subscales is 0, the highest is 36 (for the care subscale) or 39 points (for the overprotection subscale). The parental bonding then may be assigned into four categories - affectionate constraint, affectionless control, optimal parenting, and neglectful parenting.

  3. Internalized Stigma of Mental Illness Scale [ Time Frame: 1 day ]
    The scale was developed by Ritsher et al. (2003). In 29 items, it measures the extent of internalized stigma (in other words self-stigma). The scale consists of five subscales - alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance. Each statement is rated with a four-point scale according to how much the patient agrees with it. The total score lies between 29 and 116 points, higher score indicating more severe self-stigma.

  4. The Experiences in Close Relationship-Revised Questionnaire [ Time Frame: 1 day ]
    The questionnaire evaluates two basic dimensions of adult attachment - attachment-related anxiety and attachment-related avoidance (Fraley et al. 2000). The measurement consists of 36 items, first half assessing the anxiety, the second half evaluating the avoidance. Each item is rated on a seven-point scale according to the level of agreement. There are two resultant scores (one for the anxiety subscale, the other for the avoidance subscale) which present the means of the items in each subscale. These scores can lie between 1 and 7, higher scores indicating more intensive attachment-related anxiety and attachment. By a comparison with norms, it is possible to define four attachment types - secure, dismissing, fearful, and preoccupied.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932656


Contacts
Layout table for location contacts
Contact: Marie Ociskova, PhD +420588443513 marie.ociskova@upol.cz

Sponsors and Collaborators
Marie Ociskova
Palacky University
University Hospital Olomouc
Investigators
Layout table for investigator information
Principal Investigator: Marie Ociskova, PhD University Hospital Olomouc, Faculty of Medicine, Palacky University

Publications:
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.
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.

Layout table for additonal information
Responsible Party: Marie Ociskova, Assistant Professor, Palacky University
ClinicalTrials.gov Identifier: NCT03932656     History of Changes
Other Study ID Numbers: NV19-05-00105
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marie Ociskova, Palacky University:
borderline personality disorder
latent toxoplasmosis
Toxoplasma gondii
pharmacotherapy
psychotherapy
clinical features

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Personality Disorders
Borderline Personality Disorder
Toxoplasmosis
Pathologic Processes
Mental Disorders
Coccidiosis
Protozoan Infections
Parasitic Diseases
Psychotropic Drugs