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Personality Disorders clinical trials

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NCT ID: NCT06182787 Recruiting - Schizophrenia Clinical Trials

Development of a Model for Digital Monitoring of the Mental State of the Hospitalized Patient

Start date: May 18, 2022
Phase:
Study type: Observational [Patient Registry]

This study presents the development and validation of a unique Digital Experience Sampling Method (ESM) questionnaire specifically adapted for monitoring changes in the mental state of patients during psychiatric hospitalization. The questionnaire was carefully crafted through focus groups involving patients and clinical staff, ensuring its relevance and applicability to the unique characteristics of mental state changes in a hospitalization setting. To evaluate the validity of the ESM questionnaire, symptom severity trends obtained from the questionnaire will be compared with estimates derived from the Positive and Negative Syndrome Scale (PANSS) assessment. Data will be collected from 100 subjects over a 14-day psychiatric hospitalization period. In addition to the ESM questionnaire, smartwatch sensors will monitor physiological indicators. Feasibility and patient compliance will be assessed by examining patients' willingness to use the digital ESM questionnaires and the smartwatch sensors. The study will also cross-reference self-reported sleep quality and activity levels captured in the ESM questionnaires with objective physiological indicators and nursing staff reports, providing insights into the reliability of the patient-reported data. Furthermore, the study will evaluate the impact of the ESM data on clinical decision-making by physicians throughout the 14-day psychiatric hospitalization period. Patient satisfaction and satisfaction among the multidisciplinary team with the monitoring model will also be assessed. This research underscores the potential of digital technologies to enhance patient-centered care and facilitate informed treatment decisions in psychiatric hospitalization settings.

NCT ID: NCT06106555 Recruiting - Clinical trials for Borderline Personality Disorder

Which Factors Are Relevant for Treatment Outcome in Dialectical Behaviour Therapy for Borderline Personality Disorder?

Start date: September 1, 2023
Phase:
Study type: Observational

The objective of this project is to investigate factors that contribute to the success and lack of success in DBT among individuals with BPD and a history of self-harm in a clinical psychiatric setting. 1. Do certain personality factors and identity disturbance predict the treatment outcome of DBT in individuals with BPD? 2. Do changes in identity disturbance, self-hate, or emotion regulation mediate the treatment outcome of DBT in individuals with BPD? 3. Do specific personality profiles moderate the treatment outcomes of DBT for individuals with BPD? 4. When does the primary treatment effect occur, and does this effect persist after a 12-month follow-up period?

NCT ID: NCT06050486 Recruiting - Clinical trials for Child's Internalizing and Externalizing Problems

A Mentalization-based Intervention for Children of Parent(s) With Borderline Personality Disorder

Start date: September 11, 2023
Phase: N/A
Study type: Interventional

Background and study aims? Parents with borderline personality disorder (BPD) can present parenting difficulties such as expressions of hostility, low sensitivity, and overprotection. These parenting problems are associated with adverse outcomes for the offspring, namely, borderline features, depression, internalizing and externalizing problems, and interpersonal difficulties. Intervention studies with parent(s) who have borderline personality disorder show promising results regarding the improvement of parenting skills and parent-infant relationship. However, very few assess their effect on child's mental health and development. This study aims to evaluate the acceptability, feasibility and preliminary effectiveness of a mentalization-based clinical intervention, directed to school-aged children of mothers and/or fathers with borderline personality disorder, to reduce child mental health problems, in the short- and medium-term. Who can participate? School-aged children (5 to 12 years of age), with mental health problems (CBCL internalizing and/or externalizing scores must be T = 60 or above), and their mothers and/or fathers (> 18 years of age) with subclinical or clinical BPD. What does the study involve? Mother and/or father with BPD complete an online survey and an online interview. If available, the other parent and the child's teacher complete an online survey, separately. The child completes an online task with a researcher's assistance. After, participants are assigned to an intervention group (one arm, pre-posttest study). Participants receive a mentalization-based treatment for children (MBT-C), starting one week after the pre-test. MBT-C is a psychological intervention designed to resolve the child's mental health problems and promote resilience by promoting the child's and parent's mentalizing capacities. It aims to be delivered by a mental healthcare professional trained in MBT-C. In this clinical trial MBT-C will be composed of: 3 assessment sessions; 12 individual sessions with the child, plus 6 parallel individual sessions with the parent with BPD; 1 follow-up family session, 3 months after the last session. Assessment sessions are composed of one family session, one session with the child and one session with the parent. Sessions with child are in-site and sessions with parent can be on-line or in-site, according to the parents' preference. Sessions have a weekly frequency and a 50-60 minutes duration each. One week after the last intervention session participants repeat the same assessments completed before MBT-C. In addition, child and mother and/or father with BPD complete separately an online satisfaction survey and an online interview to assess participants experiences with MBT-C. We expect that after receiving MBT-C the child's mental health problems will have significantly decreased and to obtain information on the feasibility of a future large-scale clinical trial and retrospective acceptability of MBT-C with this specific population. What are the possible benefits and risks of participating? This intervention aims to resolve child's mentals mental health problems. Patients who do not meet the inclusion criteria to participate, do not consent, or withdraw from the trial will be offered a debrief and the possibility of being referred to individualized psychological support or other if needed. If child's mental health problems are not resolve by the end of MBT-C the same possibility will be offered. At the end of MBT-C mother and/or father with BPD will be referred to individual therapy, if needed and not already receiving. Intervention with BPD parents can present challenges, such as ambivalence within the therapeutic relationship (high idealization versus therapist rejection), and high drop-out rates. To overcome these difficulties, the therapist should be knowledgeable about BPD, foster a secure-based relationship with the parent and child, and maintain an empathetic stance. It is possible for parent(s) with BPD to maltreat or abuse their children, in which case child protective services must be contacted and informed. The same procedure must be adopted in case of substantial substance abuse.

NCT ID: NCT06018272 Recruiting - Clinical trials for Borderline Personality Disorder

Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany

MAGNET
Start date: February 28, 2024
Phase: N/A
Study type: Interventional

Background: Borderline Personality Disorder (BPD) is a serious mental disorder. Mentalization-based treatment (MBT) is one evidence-based treatment for individuals with BPD. Specifically, MBT has been highlighted for its effectiveness in reduction of suicidal and non-suicidal self-injury (NSSI). Yet, randomized-controlled trials (RCT) on MBT in outpatient settings compared with bona fide treatment (BFT) are still scarce and none has been conducted in Germany. The primary objective of this RCT is to investigate whether outpatient MBT is more effective in the reduction of crisis events (incidences of NSSI and suicide attempts) compared with BFT (namely psychodynamic or cognitive-behavioural psychotherapy) in Germany. Secondary, MBT's efficacy will be investigated with regard to cost-effectiveness, general and interpersonal functioning, BPD and general symptom severity, social adjustment, quality of life, reduction in psychotropic medication and therapy retention. Additionally, moderator as well as common and treatment specific mediator variables will be investigated. Study Design/ Study Population/ Methods: Across 5 study sites in Germany, 304 individuals of all genders from age 18 to 65 with a BPD diagnosis and NSSI or suicide attempts in the past will be asked to participate in the study for two years. In the first year, patients will receive either MBT or BFT (psychodynamic or cognitive behavioural psychotherapy) and will take part in continuous scientific assessments. Scientific assessments will continue after therapy completion up to a 12-moth follow up. As primary outcome, crisis events will be assessed via ecological momentary assessment (EMA) four times a week once per month during the first year and once every three months in the second year. Number of crisis events up to 2 years post randomization will be compared between treatment arms using a log-linear regression model following an intention-to-treat approach. Secondary outcomes, such as borderline and general symptom severity, will be assessed at several timepoints. A within-trial cost-effectiveness analysis (CEA) will be conducted with a societal perspective. Clinical Trial Rationale: This study investigates efficacy of MBT as BPD specific treatment in an outpatient setting compared with BFT in Germany. Results of this study can address a treatment gap in the German healthcare system, and inform about health economic aspects of BPD treatment as well as mechanisms of psychotherapeutic change.

NCT ID: NCT06005129 Recruiting - Clinical trials for Borderline Personality Disorder

Personality Change Study for Borderline Personality Disorder

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

Participants with borderline personality disorder will undergo an a 2 - 4 week baseline assessment to determine level of outcomes of interest in the absence of treatment. After the baseline period, participants will receive six weekly 50-60-minute treatment sessions. After the 6 treatment sessions, participants will complete a 4-week follow-up period to determine the sustainability of the treatment module.

NCT ID: NCT05972096 Recruiting - BPD Clinical Trials

DBT Skills Expanded With Contextual Intervention for Long Lasting Symptoms in Borderline Personality Disorder

DBT+Context
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Although borderline personality disorder (BPD) tend to the clinical remission in long-term follow-up studies, a significant subgroup of patients continues to present long lasting symptoms such as low mood, emptiness and persistent impairment in psychosocial adjustment. The prevalence of this subsample of individuals is considerably increasing last years. New interventions addressed to these individuals are need, the aim of this study is to evaluate the efficacy of a novel intervention combining dialectical behavioral therapy skills training with self-compassion and contextual-based skills for patients with long-lasting BPD.

NCT ID: NCT05964296 Recruiting - Clinical trials for Personality Disorders

The Impact of the Use of the MAURISSE Application in People Suffering From an Addiction.

ALMA
Start date: September 7, 2023
Phase: N/A
Study type: Interventional

Substance Use Disorders (SUD) are associated with cognitive schemas that lead to care attrition and mistrust towards care. Considering this, establishing a strong, trustful relationship between the patient and the healthcare team is important to promote patient engagement within SUD management. However, it requires an important availability of the healthcare team, allowing for frequent interactions at all times, including at night and during days off. We postulated that a mobile application called MAURISSE, which aims to help the caregivers maintaining a link with the patient in order to facilitate trust in the relationship, could foster patient engagement as well as the therapeutic alliance. This research aims to compare the effect of the application MAURISSE on the therapeutic alliance in a population of patients treated for a disorder related to substance use at the Toulouse University Hospital.

NCT ID: NCT05942651 Recruiting - Clinical trials for Borderline Personality Disorder

Impulsivity With Borderline Personality Disorder/tMS

IMPULSE
Start date: January 8, 2024
Phase: N/A
Study type: Interventional

This is a prospective, randomized, double-blind, parallel-group controlled trial. The aim of this research project is to compare the clinical benefits achieved in patients with Borderline Personality Disorder (BPD) following two types of intervention: ccPAS active or ccPAS sham.

NCT ID: NCT05923307 Recruiting - Depression Clinical Trials

Multifactorial Approach to Dementia, Multicentric Study

Start date: May 20, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to assess the role of narcisistic personality disorder and life stressful events in conversion rate to dementia, using a three tier approach along three research lines employing subjects with dementia in retrospective assessment, and normal subjects no yet developing demetia in prospective follow up. The main question[s] it aims to answer are: - narcisistic personality disorder as risk factor for conversion to dementia - life stressful events as risk factor for conversion to dementia Participants will be assessed with a complete neurocognitive battery, brain images studies, laboratory analysis, and sociodemographic profile, including depression and comorbidities.

NCT ID: NCT05913544 Recruiting - Clinical trials for Borderline Personality Disorder

Short Integrative And Neurocognitive Therapy For Young Adults With Borderline Personality Disorder

SINTYA
Start date: November 8, 2023
Phase: N/A
Study type: Interventional

Borderline personality disorder (BPD) is a severe, high-suicidal psychiatric disorder associated with impulsive, endangering behaviors. Young patients between 16 and 25 years old do not respond to traditional psychotherapies, which are often long and not adapted to their neurocognitive alterations linked to early trauma. The study authors hypothesize the SINTYA therapy program (one group session and one individual session weekly for 10 weeks) would reduce the level of impulsivity and clinical symptomatology (severity of the BPD; emotional regulation difficulties; dissociative symptoms; aggressiveness; ruminations; the number of self-destructive behaviors and suicidal acts; impulsive behaviors; level of suicide risk and hopelessness; the number of psychiatric hospitalizations and emergency visits for psychiatric reasons; and finally improving psychosocial functioning).