Clinical Research Directory

Long Term Follow-up of Mentalization-Based Treatment: Exploring Variability in Outcomes, Long-term Value and Experiences 10+ Year After Receiving MBT Day Hospital or MBT Intensive Outpatient

This study is a long-term follow-up study of a previous multicenter randomized controlled trial, in which n=114 participants were included. This RCT compared the effectiveness of two intensities of mentalisation-based treatment (MBT) for individuals with borderline personality disorder (BPD). The goal of this study is to learn how people who received MBT in the past for BPD are doing more than 10 years later. MBT is a type of psychotherapy that helps people understand and manage their thoughts and feelings, and supports improvements in identity and relationships, with the aim of improving daily life functioning. The main questions this study aims to answer are: 1. How are people who received MBT in the past functioning more than 10 years later, and how is their use of mental health care and associated costs at this point in their lives? 2. Do long-term outcomes differ between people who received day-hospital MBT and people who received intensive outpatient MBT, and are these outcomes influenced by how much time has passed since treatment ended or by clinical characteristics from the past, such as symptom severity, trauma history, or level of mentalizing? 3. How do people who received MBT experience its impact on their symptoms, daily life, and relationships both during treatment and in the years afterward, including the impact of treatment intensity? Participants will: * Fill in online questionnaires about symptoms, relationships, health, and daily functioning (about 60 minutes). * Take part in a short interview to check whether BPD symptoms are still present (about 20 minutes). * A smaller group will be invited for a longer semi-structured qualitative interview (about 60 minutes) to talk about their personal experiences with MBT and what has impacted their life after treatment. There are no new treatments in this study. All participants completed MBT many years ago. Participation happens online or in person based on personal preference.

A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder

This study is open to adults with borderline personality disorder (BPD) and with attention deficit/ hyperactivity disorder (ADHD). The purpose of this study is to find out how a medicine called BI 3031185 is tolerated by people with BPD or ADHD. Participants with BPD with ADHD are in separate cohorts. Participants from each cohort are put into 2 groups of equal size randomly, which means by chance. Group 1 takes a single dose of BI 3031185 and Group 2 takes placebo. After a 2-week break, Group 1 takes placebo and Group 2 takes a single dose of BI 3031185. Participants take BI 3031185 and placebo as tablets. Participants are in the study for about 1 to 2 months. They visit the study site 6 times and have 3 phone or video call visits. For 2 of the visits, participants stay overnight at the study site for 2 nights. During all the visits, doctors check participants' health and take note of any unwanted effects.

Testing Interventions for Borderline Personality Disorder.

Borderline personality disorder (BPD) is a life-threatening, costly public health crisis affecting \~1-3% of North Americans, with 10% dying by suicide and annual healthcare costs of \~$63k (Canadian Dollars)/patient. Further, people with BPD's intimate relationships are highly disrupted, and their partners report elevated mental health problems but little access to treatment. Existing BPD treatments are resource-heavy, inaccessible, and 47% of people with BPD do not respond to them. These treatments also neglect relationship problems and intimate partner's mental health concerns, even though they are thought to play a key role in BPD maintenance. BPD interventions may produce stronger, quicker, and more durable outcomes if they incorporated partners to target both the emotional and relationship core of BPD. Moreover, incorporating partners into interventions may improve relationship outcomes and partner mental health without added resource investments. Accordingly, members of our team developed Sage. Named after a plant that thrives in relationship with its ecosystem, Sage is a brief, 12-session conjoint intervention for people with BPD and their intimate partners that targets BPD, relationship conflict, and partner mental health. Our recent uncontrolled trial provides preliminary support for its efficacy. As a next step in testing Sage, it is critical to utilize a Randomized Controlled Trial (RCT) design to identify if Sage is more efficacious than standard care that these couples typically receive; supportive individual psychotherapy (SIP) for people with BPD and their partners. The investigators propose to conduct the first RCT of Sage for couples wherein one member has BPD. The study will examine if Sage is more efficacious than SIP in improving BPD symptoms (primary outcome), as well as relationship conflict and partner mental health (secondary outcomes), as well as a range of other outcomes, from pre- to post-intervention, and post-intervention to follow-up. It will also investigate factors that influence treatment response, BPD severity, and related problems. Up to 152 couples wherein one member has BPD will be randomized to receive Sage or SIP. Gold-standard measures of primary, secondary, and exploratory outcomes will be administered at baseline, mid-intervention, post-intervention, and a one-month, three- month, and six-month follow-up.

Pilot Study on Auricular Acupuncture in Hospitalized Adults With Borderline Personality Disorder

The goal of this pilot study is to evaluate the feasibility and preliminary effectiveness of a brief auricular acupuncture program delivered by mental health nurses as a complementary therapy for adults hospitalized with borderline personality disorder (BPD). The main questions it aims to answer are: * Is participation in the five-session auricular acupuncture program feasible (in terms of attendance) for hospitalized adults with borderline personality disorder? * Does the auricular acupuncture intervention show potential benefits on emotional regulation, anxiety, sleep quality, and overall clinical status? 15 hospitalized adults with BPD will receive 5 individual ear acupuncture sessions, over a 9-day period, based on the National Acupuncture Detoxification Association (N.A.D.A.) protocol in addition to treatment as usual. Participants will complete brief questionnaires at several time points. The findings will inform the feasibility of the study procedures and guide the development of a future larger-scale clinical trial.

Neurostimulation Versus Therapy for Problems With Emotions

The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training. Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.

Effectiveness of EMDR in Borderline Personality Disorder

Borderline personality disorder (BPD) is a severe mental disorder characterized by four major symptomatological domains: interpersonal instability, perceptive and identity disorders, emotional and behavioural dysregulation. Considering a multifactorial etiological model, it has been suggested that the interaction between behavioral, environmental and genetic factors may promote the development of BPD. Early life stress events (ELS) in childhood and adolescence are highly prevalent in this population and constitute an environmental risk factor for the development of BPD. This correlates with the fact that Post-traumatic Stress Disorder (PTSD) is frequently comorbid in BPD leading to more severe symptoms and worse psychosocial functioning. At the therapeutic level, the treatment of BPD is an open challenge as psychotherapeutic interventions are of limited effectiveness and characterized by high drop-out rates. Eye Movement Desensitization and Reprocessing (EMDR) is the gold standard for treating PTSD. However, scientific evidence on the application of EMDR in patients with BPD is limited. This study aims to assess the feasibility and effectiveness of an EMDR protocol on the nuclear symptomatology of BPD (emotional and behavioral dysregulation) in a group of DBP patients with/without PTSD comorbidity, through a systematic assessment of the peculiar dimensions of the disorder. The basic hypothesis is that EMDR, through a short-term intervention, can act both on the traumatic PTSD-like experiences reported by patients and on the clinical manifestations peculiar to DBP, in particular by improving the emotional regulation capacity of patients with BPD.

Brain Signal Training to Enhance Affect Down-regulation

Individuals with Borderline Personality Disorder (BPD) experience intensive, instable negative emotions. Hyperactivity of the amygdala is assumed to drive exaggerated emotional responses in BPD. Neurofeedback is an endogenous neuromodulation method to address the imbalance of neural circuits. Downregulation of amygdala hyperactivation with neurofeedback may ameliorate dysregulated emotions in BPD. The BrainSTEADy trial is designed to determine whether amygdala-fMRI-BOLD neurofeedback has a specific effect on affect instability in BPD beyond nonspecific benefit.

PILOT Phase: BPD Study

This pilot study aims to identify the area of the brain best suited for the treatment of Borderline Personality disorder (BPD). The study investigators will test whether repetitiveTranscranial Magnetic Stimulation (rTMS), a gentle non-invasive brain stimulation method, can improve regulation of emotions and impulsivity in individuals with BPD. This study will enroll up to 20 participants. Participant will be consented for the study remotely via a secure internet platform called Zoom. Participants will undergo 1 Magnetic Resonance Imaging or MRI scan and up to 3 brain stimulation of transcranial magnetic stimulation or TMS sessions, and cognitive behavioral testing on a computer. Participants will complete 4 in-person visits over the course of up to 3 weeks.

MDMA in Borderline Personality Disorder

The purpose of this study is to test the effects of MDMA (3,4-methylenedioxymethamphetamine) on social cognition in adults with Borderline Personality Disorder.

Conceptualizing Borderline Personality Disorder as a Relationship Use Disorder

This study aims to explore a novel conceptualization of Borderline Personality Disorder (BPD) as a "Relationship Use Disorder." The research proposes that BPD shares key features with behavioral addictions, specifically addiction to interpersonal relationships. The study builds upon previous findings suggesting that individuals with BPD experience intense emotional dysregulation, including negative self-perception, shame, and a compulsive need for external validation. This addiction to relationships, much like substance use disorders, is thought to contribute significantly to the difficulties faced by these individuals, including interpersonal conflicts, self-destructive behaviors, and emotional instability. The study seeks to demonstrate that the relational difficulties central to BPD meet the diagnostic criteria for addiction as defined by the DSM-5. It will also explore how these relational struggles are mediated by dysfunctional self-perception and whether they are linked to behaviors such as compulsive sexual behaviors (CSBD) or suicidal tendencies. Additionally, the research will investigate the relationship between addiction to relationships and neurobiological factors, including endorphin levels, in individuals with BPD compared to those with bipolar disorder and healthy controls. The hypothesis is that individuals with BPD will exhibit higher levels of relationship addiction, with this addiction being tied to their perception of self-worth and emotional experiences in relationships. This innovative approach aims to refine the understanding of BPD, reduce stigma, and improve treatment strategies by providing scientific evidence supporting the conceptualization of BPD as a "Relationship Use Disorder."

Personality Change Study for Borderline Personality Disorder

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.

Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS

This study evaluates the antidepressant effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), in individuals with borderline personality disorder (BPD) or trait and comorbid mood depressive disorder (MDD) or bipolar II disorder in a current mood depressive episode (MDE).

Cognitive Reappraisal Training for Borderline Personality (BPD)

Previous work by the group convinced the researchers to pursue development of focused cognitive reappraisal training as a novel approach to treatment of BPD, either as stand-alone treatment or in concert with evidence-based treatments of BPD. The present proposal aims to refine and test a proposed clinical intervention for BPD patients, training in reappraisal-by-distancing, in terms of its ability to influence hypothesized neural and behavioral targets and, once that is established, to demonstrate its ability improve clinically relevant outcome measures.

Testing an Alliance-Focused Dialectical Behaviour Therapy Training for Borderline Personality Disorder

The study evaluates the feasibility, acceptability, and effect sizes of two alliance-focused dialectical behavior therapy (DBT) training interventions to improve therapists' abilities to recognize and respond to alliance ruptures with clients with borderline personality disorder (BPD). Participants will be randomly assigned to receive either a 4-week training as usual (TAU), which include didactic training plus reflective practice (i.e., thinking about past actions to gain insight for future actions) or a 4-week didactic training plus deliberate practice training (i.e., setting individualized training goals, skills coaching, and opportunities for repeated practice with expert feedback). A pre-post design will be used to assess effect sizes for change in participants' abilities to recognize and respond to alliance ruptures. Therapist characteristics will be assessed to determine moderating effects on training outcome. Feasibility and acceptability of the training intervention will be assessed following the trainings.

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

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).

Neurofeedback for Borderline Personality Disorder

The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as an intervention for borderline personality disorder.

Treatment of Borderline Personality Disorder With rTMS

This project studies the effectiveness of brain stimulation on borderline personality disorder (BPD) symptoms. This study is blinded, randomized and will enroll up to 30 participants. Participant will be consented for the study remotely via a secure internet platform called Zoom. Participants will undergo up to 2 MRI scans, 2 brain wave recording sessions and up to 30 brain stimulation treatments, and complete symptom assessments and cognitive behavioral tasks on a computer. Participation requires minimum of 17 in person visits over the course of 2.5 months. Participants are randomly assigned active or sham brain stimulation. Participants who received sham brain stimulation have the option to receive additional 15 active brain stimulation session.

SHame prOpensity in bOrderline Personality Disorder

Borderline Personality Disorder (BPD) is a common psychiatric disorder occurring in 2 to 6% of the population. 70% of patients with BPD do at least one Suicide Attempt (SA) in their lives. It makes BPD the most related to SA condition. Negative interpersonal events are among the main stressor inducing a SA. Patients with BPD are characterized by emotional dysregulation, impulsivity (repeated parasuicidal and suicidal behaviors), and instability in interpersonal relationships. The feeling of shame related to this psychiatric disorder could be one of the causes of the high SA rate. In this study, patients with BPD will be follow-up during 5 years. The main objective is to study the propensity to feel shame as a predictor of SA. This include: * Study of shame propensity as a predictive factor of suicidal behavior - Identify homogeneous subgroups of patients with BPD based on SA, and overall functioning. * Identify biological markers predicting SA * Identify predictive and protective treatments (pharmacological and psychotherapeutic) for SA

Effectiveness of Autobiographical Rewriting Workshops on the Socio-Professional Functioning of Patients With Borderline Personality Disorder Undergoing Third-Wave Cognitive and Behavioral Therapy: A Randomized Controlled Trial

This study evaluates the effectiveness of autobiographical rewriting workshops combined with third-wave Cognitive Behavioral Therapy (CBT) in improving social and professional functioning in individuals with Borderline Personality Disorder (BPD). BPD affects approximately 2 to 6% of the general population and is frequently associated with suicidal behaviors, unstable relationships, and low self-esteem. This disorder is often linked to early traumatic experiences that impact autobiographical memory and self-perception. While Dialectical Behavioral Therapy (DBT) is a standard treatment for BPD, it does not fully address all the needs of patients. The aim of this study is to determine whether autobiographical rewriting, which allows individuals to restructure and reinterpret their memories in a more resilient way, can improve autobiographical memory, self-esteem, and reduce emotional symptoms. Participants will be randomized into two groups: one group will undergo autobiographical rewriting workshops in addition to third-wave CBT sessions, while the other group will participate in non-specific writing sessions also in addition to third-wave CBT sessions. The study will compare the two groups to evaluate the effectiveness of autobiographical rewriting workshops in enhancing social and professional well-being. Expected outcomes include improvements in interpersonal relationships, greater professional stability, and a reduction in emotional symptoms assessed immediately post-intervention, then 3 months and 6 months after. This study may offer a complementary therapeutic approach to existing treatments, helping patients manage their symptoms more effectively and improve their quality of life.

rTMS-enhanced Psychotherapy for Borderline Personality Disorder

This project assesses the effectiveness and lasting impact of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in patients with borderline personality disorder.

The Effectiveness of Group Schema Therapy in the Treatment of Borderline Symptoms in Adolescents

The goal of this randomized and controlled trial is to assess the effectiveness of group schema therapy in the treatment of adolescents with borderline symptoms. The intervention utilizes self-recorded video material as an experiential method. The intervention comprises 30 group sessions and 8 individual sessions. Additionally, there are group sessions for the participants' parents. Participants in the control group receive treatment as usual.

Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations

In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain.

A Novel Drug for Borderline Personality Disorder

Borderline Personality Disorder (BPD) is one of the most prevalent psychiatric disorders with high morbidity and mortality. It affects the lives of millions worldwide and is often highly incapacitating, leading to significant psychosocial dysfunction. Moreover, nearly all patients have experienced suicidal ideation and about 10% actually commit suicide, a rate almost 50 times higher than in the general population. Mostly young women are at greater risk for the disorder and are three times more likely to be diagnosed with BPD than men. BPD aetiology is complex and could be explained by both biological and environmental factors. Among the environmental factors, sexual or physical abuse, parental divorce, loss or illnesses are identified as the most common ones. These factors can induce dysfunctional behaviours, which might cause emotional dysregulation, high impulsivity and frequent self- injurious behaviour. However, there are no pharmacologic interventions that are known to be specifically effective to treat BPD. Therapeutic options for this devastating disorder is still far from adequate for treating acute illness episodes, relapses, and recurrences and in restoring premorbid functioning. In addition, some patients are unable to tolerate existing therapies for BPD, which leads to either frequent changes in medications or to non-adherence. Therefore there is an urgent need for the development of more rapidly effective treatments for BPD. A growing body of evidence suggests that glutamatergic neurotransmission, in particular N-methyl-D-aspartate (NMDA) subtype may play a role in the pathophysiology of multiple psychiatric disorders. This has led to various clinical trials with glutamate modulating drugs. The trial drug is an uncompetitive NMDA receptor antagonist approved for Alzheimer's disease is increasingly being studied in a variety of non-dementia psychiatric disorders. Results from these studies have proved that the trial drug was safe and well tolerated and has the potential for use in the treatment of psychiatric disorders. To date, there are no published data on the use of trial drug in the treatment for BPD. Therefore, the investigators intend to study the efficacy of this novel drug as an addition to ongoing therapy with atypical antipsychotics in patients with Borderline Personality Disorder. This study will recruit 150 BPD patients. The patients will be randomly allocated to receive either the study medication (20mg/ day) or placebo via oral administration for twelve weeks. To observe the efficacy of the trial treatment, all participants will be assessed at various time intervals for different borderline and cognitive symptoms.

Brief Admission by Self-referral for Individuals With Self-harm: Effects on Compulsory Care

Brief Admission by self-referral (BA) is a standardized treatment model, providing patient-controlled and person-centered care. It was developed to reduce self-harm and compulsory care by promoting autonomy. Randomized clinical trials have not yielded significant between group differences with respect to inpatient care, including compulsory care. The major difficulty in evaluating BA is preventing the control group from cross-contamination, as in the implementation process of BA, all physicians, all inpatient and outpatient staff as well as managers need to be informed and undergo basic education regarding the intervention. As BA addresses a prevalent and frustrating issue in psychiatric health care, there is considerable risk that the approach leaks to the control group, reducing the possibility to detect between-group differences. In the current study this will be addressed through a register-based approach, comparing similar clinics, implementing BA at different timepoints over time. Individuals with traits of borderline personality disorder will be included and comparisons will be made with respect to compulsory care, voluntary inpatient care and mortality.