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Personality Disorders clinical trials

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NCT ID: NCT06355284 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Overcontrol and Suicide in PTSD

OSP
Start date: July 1, 2024
Phase:
Study type: Observational

High standards and self-discipline are prized in military culture, but drawbacks of overcontrol are often ignored. Overcontrol is characterized by over-regulated behavior and cognitive rigidity, driven by an intense need for perfection and control. It is frequently observed in people with obsessive-compulsive (OC) spectrum disorders, especially OC Personality Disorder (OCPD). Their inclination to set high expectations for others can strain social bonds. When grappling with mental health challenges, overcontrolled individuals often do so with limited social support, and as a result, tend to be at greater risk of developing more severe mental health symptoms, or suicidal thoughts and behaviors, over time. New treatments are needed to improve social functioning in these vulnerable Veterans. Adding brain stimulation to psychotherapy is one method that might speed learning of social skills discussed in therapy. However, before this technology can be developed and tested more broadly, the investigators must make sure that the methods used to measure social functioning and related brain circuits are acceptable to most potential patients and can be used consistently. In this pilot project, the investigators aim to recruit trauma-exposed Veterans with overcontrolled traits and study the feasibility and acceptability of: 1. Our recruitment strategy and social functioning and mental health symptom assessments 2. A three-session, weekly fMRI protocol. 3. A three-week online protocol for remote monitoring of social and emotional functioning.

NCT ID: NCT06212024 Not yet recruiting - Clinical trials for Borderline Personality Disorder

MBT-early: a Single Case Experimental Design

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

Borderline personality disorder (BPD) is characterized by problems in emotion regulation, identity disturbances, and impaired interpersonal functioning. Because BPD may determine health and quality of life in long term, it is important to focus on early detection and early intervention to prevent worsening. In this study, the effectiveness of a new intervention, MBT-early, is investigated in adolescents with borderline personality problems through a single case experimental design (SCED). Existing studies into the efficacy of psychotherapeutic interventions for young people with a (subclinical) borderline personality disorder (BPD) show mixed results. An obvious explanation therefore lies in the heterogeneity of the samples studied, where the same intervention is investigated by young people with some characteristics of borderline personality problems in an early stage as by young people with significant borderline personality problems at a later stage. However, there is evidence that interventions should be targeted specifically at the stage of progression of the disorder ('staged care'). Interventions may be more effective when they correspond to the stage of disease progression. MBT-early is an intervention intended for young people in an early stage of BPD. The intervention not only addresses the characteristics of BPD, but generally aims to improve personality functioning. MBT-early focuses on strengthening the young person's mentalizing capacity and to increase epistemic trust (the openness to learn from others) in order to prevent developmental stagnation and chronic consequences of personality disfunctioning. Although there is evidence for the efficacy of MBT for adults and adolescents, MBT-early has not yet been studied in terms of effectiveness. This study sets out to investigate the effectiveness of MBT-early, using a Single Case Experimental Design. The investigators hypothesize that treating youngsters with early features of BPD with MBT-early results in reduction of features of personality problems and the most frequently occurring symptoms (depressive symptoms). Exploratively mechanisms of change are being explored. Research questions: 1. What is the effectiveness of MBT-early in youth with early stage BPD? 1a) What effect does MBT-early have on the improvement of personality functioning? 1b) What effect does early MBT have on the degree of depressed mood? 2. What are the possible working mechanisms of MBT-early? 2a) Does the youth's mentalizing ability influence the improvement of personality functioning? 2b) Does epistemic trust affect the improvement of personality functioning? Objective of the study: The primary objective is to study the effectiveness of MBT-early in terms of treatment outcome on personality functioning and depressive symptoms. As a second objective the investigators will exploratively study the presumed working mechanisms of the MBT-early intervention (mentalizing capacities and epistemic trust).

NCT ID: NCT06195553 Not yet recruiting - Clinical trials for Borderline Personality Disorder (BPD)

Application and Effectiveness of the STEPPS in Patients With BPD, Extending to Their Families With the FC Program

Start date: January 2, 2024
Phase: N/A
Study type: Interventional

The present research project is framed within the issue of Borderline Personality Disorder (BPD). This condition stands as one of the most common challenges encountered within the mental health services of the National Health System. The primary objectives of this research are to verify whether the combined use of established treatments for patients and their families, conducted in parallel, leads to a greater improvement in patients and their families, respectively. Additionally, another aim of the project is to assess efficiency, defined as the acceptance of intervention programs by patients, their families, and clinical professionals, as well as to demonstrate their feasibility.

NCT ID: NCT06176638 Not yet recruiting - Depression Clinical Trials

Resettled Refugee Families for Healing

RRF4H
Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this type I hybrid effectiveness-implementation trial is to test a family strengthening (FS) model delivered through multiple family groups (MFG) combined with a virtual peer mentoring program called TeenAge Health Consultants (Virtual TAHC) aimed at addressing emotional and behavioral problems among youth born in the U.S. to parents resettled as refugees. The specific aims of the study are: Aim 1: To systematically adapt an evidence-based family strengthening (FS) model delivered through multiple family groups (MFG) combined with a peer mentoring program (Virtual TAHC) (Goal 1). Aim 2: To assess preliminary short- and long-term impact of the combination intervention (MFG + Virtual TAHC) on behavioral emotional disorders (aggressive behavior, antisocial behaviors, anxiety, depression, and Posttraumatic Stress Disorder [PTSD]) related to intergenerational trauma among SGRC in the trial (Goal 2). Aim 3: Utilizing mixed methods and applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, examine implementation strategies, facilitators, and barriers of the RRF4H intervention (Goal 3). Participants will receive: 1. Family strengthening intervention delivered through multiple family groups (MFG) where children and one of their biological parents will participate in 16 weekly group sessions to discuss common problems and how to address them. 2. The youth in the intervention will participate in a peer mentorship program called TeenAge Health Consultants (TAHC) consisting of 16 weekly virtual sessions where they interact with other youth to learn about important topics including how to deal with conflict, stay out of trouble, deal with stress, avoid drugs and other topics. Researchers will compare the intervention group to a control group that will receive the usual care to see if the intervention group shows improvement in symptoms compared to the usual care group.

NCT ID: NCT06135090 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Testing a Peer-led Trauma-focused Intervention for Significant Others of Those With BPD

Start date: February 1, 2024
Phase: Phase 1
Study type: Interventional

This project involves developing and piloting a peer-led intervention focused on posttraumatic stress symptoms for the family members and significant others of people with borderline personality disorder. The project involves collaborating with The Sashbear Foundation who will be delivering the trauma response program (TRP) that was developed by the investigative team to its network. In phase 1 of this project, the investigators will evaluate the first delivery of the TRP at The Sashbear Foundation and solicit feedback from peer-facilitators and recipients who consent to research participation. In phase 2 of this project, the investigators will evaluate the efficacy, acceptability, and safety of the delivery of the next two to four TRPs delivered at The Sashbear Foundation consisting of up to approximately 10 group members (maximum number of TRP recipient research participants in phase 2 is 40).

NCT ID: NCT06115200 Not yet recruiting - Depression Clinical Trials

Norwegian Adult Mental Health Registry

NAMHR
Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

"The Norwegian Adult Mental Health Registry" (NAMHR) is a medical quality register collecting and systematizing data on patients and their treatment in specialist mental health care for adults in Norway. The main purpose is to create a documentation basis for quality assurance, evaluation, and improvement of assessment and treatment for patients who are offered treatment for mental disorders in the specialist health service. The register uses automatic data capture from various existing data sources. New patients are automatically included, but given the opportunity for reservations from the register without affecting their services and treatment.

NCT ID: NCT06102564 Not yet recruiting - Clinical trials for Mother-Child Relations

GST-moms: Effects of Group-schematherapy on Mother-child Attachment Relations

Start date: November 2023
Phase:
Study type: Observational [Patient Registry]

The birth of a baby can be a stressful period. Dysfunctional schemas of the 'new' parent can be triggered making it more difficult to discern what the baby needs are. In schema therapy terms, mentalizing capacity is best described as the "healthy adult mode". A parent who responds to her baby from a healthy adult mode provides the baby a safe environment for self-development. However, interpreting the baby's signals can be a constant challenge for some parents. This can trigger early attachment relationships and schemas. At such times, the parent may become overwhelmed by their own emotions and respond less adequate to the child's needs. Distorted parental reflective functioning is associated both with insecure attachment and poor affect regulation in the parent and with various psychological disorders in the child. Treatments aimed at improving parental reflectiveness seem to have a positive impact on the quality of the attachment between parents and their baby. The objective of this study is to measure the effects of the group-schematherapy for mothers with young children (GST moms) on mother-child attachment relations. The aim is to help moms regulate their own emotions, by understanding their own modes and schema's. In doing so will help them feel more confident to mentalize about their child and to adequately respond to their needs and emotionally bond with their baby. The researchers anticipate it will improve the quality of attachment between mother and child. Many studies have been done on the effectiveness of group schematherapy however there are no studies specifically for schematherapy for parents, in this case mothers. GST moms can be an early intervention aimed at prevention of psychological problems with the child.

NCT ID: NCT06045650 Not yet recruiting - Clinical trials for Borderline Personality Disorder

Relationship Between Oxytocin Level, Trust, and Attachment in Individuals With Borderline Personality Disorder

Start date: February 9, 2024
Phase:
Study type: Observational

We aim to assess the baseline oxytocin levels in individuals with borderline personality disorder and correlate those levels with social behavior, and compare the results with controls. Primary Hypothesis (H1): There is a significant difference in trust-related behavior as measured by oxytocin (OXT) levels between borderline personality disorder (BPD) patients and healthy controls. Secondary Hypotheses: H2: The trust-related behavior in BPD patients is significantly influenced by their level of emotional sensitivity. Specifically, higher emotional sensitivity in BPD patients is associated with lower trust-related behavior and vice-versa. H3: There is a significant correlation between trust-related behavior and childhood trauma in BPD patients. BPD patients with higher levels of reported childhood trauma will exhibit lower trust-related behavior compared to those with lower levels of trauma. H4: Trust-related behavior in BPD patients varies depending on their attachment styles. Specifically, BPD patients with insecure attachment styles will exhibit lower trust-related behavior compared to those with secure attachment styles. H5: There is a significant correlation between trust-related behavior and BPD severity. Patients with more severe BPD symptoms will exhibit lower trust-related behavior compared to those with less severe symptoms. H6: The levels of OXT in BPD patients will significantly correlate with their reported levels of emotional sensitivity, childhood trauma, attachment styles, and BPD severity. These hypotheses aim to address the complexities surrounding the modulation of trust-related behavior by oxytocin in BPD patients, taking into account various factors like emotional sensitivity, childhood adversity, attachment styles, and BPD severity. By testing these hypotheses, the study aims to provide a comprehensive understanding of the interplay between these factors in influencing trust-related behavior in BPD patients.

NCT ID: NCT06018727 Not yet recruiting - Clinical trials for Borderline Personality Disorder

Role Of Sensitivity to neuroEndocrine Systems in Social Decisions

ROSES
Start date: July 2024
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to answer is how neuroendocrine activity impacts decision-making. This study has two components. First, there will be an online session that participants complete to consent into the study, complete self-report surveys and a cognitive assessment, and confirm their eligibility for the second part of the study. If eligible to continue, participants will complete one in-person experiment session, during which they will complete self-report measures and a decision-making task. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine.

NCT ID: NCT06018272 Not yet 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: January 15, 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.