Clinical Research Directory

Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder

The primary objective of the study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD).

Mechanisms of Change in Brief Treatment for Borderline Personality Disorder

The present two-arm randomized controlled study aims at testing the effects (i.e., symptom reduction) and the underlying mechanisms of change associated with a brief psychiatric treatment (10 sessions over 4 months), compared with treatment as usual. Participants undergo assessments at four points (intake, 2 months, discharge and 12 month follow-up). In addition to symptom measures, all individuals undergo a two-step assessment for the potential mechanisms of change (i.e., emotion and socio-cognitive processing): a) behavioural and b) neurofunctional. We hypothesize that change in the mechanisms explains the treatment effects. The present study uses an innovative treatment of BPD and at the same time a sophisticated assessment procedure to demonstrate the critical role of psychobiological change in emotion and sociocognitive processing in brief treatments. It will help increase the effectiveness of initial treatment phase for BPD and help diminish the societal burden of disease related with BPD. This study is funded by the Swiss National Science Foundation (SNSF).

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.

Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder

The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) to increase the benefits of evidence-based psychotherapy for adults with Borderline Personality Disorder (BPD).

Predictors of Clinical Course and Treatment Response in DBT Programmes

The project is a collaboration between The National Centre for Suicide Research and Prevention (NSSF) and clinical units with Dialectical Behaviour Therapy (DBT) programmes. A methodological and technological platform has been established that enables clinicians to deliver high quality treatments over extended periods of time, to evaluate their own performance and productivity and to report it in a uniform and systematic way that will enable comparison across clinical settings and programmes. The collected data constitute the basis for conducting the clinical study with the overall aim to study predictors of the clinical course and treatment response in patients admitted to DBT programmes in Norway.

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.

ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder

ADEPT is an open-label proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with Dialectical Behavior Therapy for participants with borderline personality disorder. Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive preparation therapy sessions, two supervised 25 mg psilocybin dosing sessions, integration therapy sessions, and a final follow-up visit. Participants will continue their usual DBT program during study participation. The study will primarily assess safety and tolerability, including adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging psychedelic experiences, psilocybin-related side effects, study retention, therapy session attendance, and assessment completion.

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.

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.

Disorders of the Sense of Self and Physical Activity

Schizophrenia (SZ) patients with metabolic syndrome, patients with vestibular syndrome, and patients with borderline personality disorder, would benefit from physical activity (PA). Yet patient adherence to PA is low, at least in the case of SZ. the investigators work and the literature lead the investigators to consider that, in addition to motivational aspects, disorders of the bodily sense of self could play a role in this lack of adherence. Simply walking involves visual movements related to the self, which must be distinguished from movements in the environment. This means a distinction between self and not-self. Furthermore, these movements are all the more difficult to distinguish as they may also result from the fact that hidden objects become visible as a result of our own movement. In all sense-of-self disorders can themselves affect physical training, and the investigators will measure them in the first stage. In the second stage, the investigators will apply a standard, risk-free PA protocol by walking (3x3 sessions of 30 min). the investigators will test the impact of physical training on the sense of self under different conditions, with one environment minimizing self-related movement, vs. 2 environments with a variable level of enrichment (i.e. hidden objects inducing more or less self-related movement). At the end of the protocol, the investigators will offer participants who wish to take part in an ancillary study, i.e. a walking session with mixed-reality goggles. These will superimpose a luminous flux on the periphery of the visual field. According to results obtained in the laboratory, this flux could restore sensory mechanisms impaired in schizophrenia. the investigators will use these glasses in the most difficult condition for the patient, and verify their impact.

COMpassion for Psychiatric Disorders And Self-Stigma

People with mental disorders face frequent stigmatizing attitudes and behaviors from others . In response to this, they tend to isolate themselves, with the risk of impeding care and the process of recovery and integration into society . Stigmatization can also be assimilated by patients themselves - i.e. self-stigma. Self-stigma is involved in diminished coping skills that lead to social avoidance and difficulties in adhering to care . Reducing self-stigma and its emotional corollary, shame, is thus crucial to attenuate the disability associated with mental illness. Shame is inherent to self-stigma and leads to difficulties in adhering to care as well as greater severity of clinical presentations . Compassion Focused Therapy (CFT) is a third wave cognitive behavioral therapy that targets shame reduction and hostile self-to-self relationship and allows for symptom improvement while increasing self-compassion, a major resilience factor . Although shame is a prominent part of the concept of self-stigma, the efficacy of CFT has never been evaluated in individuals with high levels of self-stigma. In this study, the investigators will evaluate the efficacy and acceptability of a group based CFT program on decreasing self-stigma, compared to treatment as usual (TAU) and a psychoeducation program whose efficacy has been assessed in a previous trial.

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.

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).

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.

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 certain mental health conditions. The purpose of this study is to find out how a medicine called BI 3031185 is tolerated by people with certain mental health conditions. Participants 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 3 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.

Effects of Psychiatric Admissions on Self-harm and Suicide in People With Borderline Personality Disorder

The current study aims to evaluate the impact of long (\>5 days) and/or compulsory psychiatric inpatient care on subsequent healthcare utilization for self-harm and suicide in people with borderline personality disorder, a condition characterized by frequent self-harm. The basis for this study is the diversity of clinical practices across Swedish regions. By categorizing clinics based on their practices with respect to long and/or compulsory psychiatric inpatient care, it is possible to explore the impact of these practices on subsequent somatic and psychiatric healthcare, including emergency care due to self-harm as well as on completed suicides. All psychiatric clinics across Sweden authorized to administer compulsory care for adults, totalling 78 clinics will be included. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022). Data collection will involve the utilization of the national registers to capture outcome measures and account for confounding factors. The participants will be ranked based on a composite variable, which includes the average number of days spent in inpatient compulsory care and other psychiatric inpatient care exceeding 5 days, among individuals diagnosed with BPD. The top quartile of participants will be compared with the bottom quartile.

Real-time Experiences With Sleep Training Study

Borderline personality disorder (BPD) is a serious mental illness that often first emerges in adolescence. Effective treatments are typically expensive, lengthy, and intense (e.g., Dialectical Behavior Therapy). Thus, setting individuals up for treatment success is extremely important. Disrupted sleep is closely linked to many BPD symptoms (e.g., moodiness, impulsivity, interpersonal problems), and people with BPD have a range of sleep-related problems. Importantly, sleep problems may make BPD symptoms worse, longer lasting, and also interfere with learning new skills in treatment. Understanding sleep problems in BPD may help create better interventions, as most therapies for BPD do not currently address sleep difficulties. Although approaches like Cognitive Behaviour Therapy for insomnia (CBT-I) and the Youth version of the Transdiagnostic Sleep and Circadian Intervention (TSC-Youth) work well with many populations, scientists don't yet know if youth with BPD features can tolerate a sleep-focused intervention. The investigators will recruit youth between ages 13 and 18 who have 3 or more clinically impairing BPD symptoms from the Salt Lake City community, via chart review, and via clinician referrals. They will also recruit a parent to report on their child's sleep patterns, mental health symptoms, and accompany youth to an intervention session. Participants will complete diagnostic interviews and a range of surveys to assess their current functioning (e.g., sleep, mental health, BPD symptoms). Investigators will also ask youth to report on their BPD symptoms multiple times per day in real time and track their sleep at night for a 10-day period. Participants will also wear a headband to track their brain waves while they sleep. After an initial 10-day monitoring period, youth participants will receive a brief, single-session sleep intervention with their parent using materials from the TSC-Youth protocol. Adolescents will be asked to follow a sleep plan created during their visit for three weeks before completing another 10 days of assessment. Participants will complete a follow-up survey battery upon completion of the second real-time survey protocol, and also be invited to complete surveys one-month post intervention. The investigators hypothesize that day-to-day variability in sleep will influence BPD symptom presentation, and vice versa. They also hypothesize that our intervention will improve sleep quantity/quality among an at-risk sample, and may be associated with decreased BPD symptoms relative to baseline.

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.

Development and Initial Testing of a Couple-Based Intervention to Optimize Suicide and Self-Injury Treatment: COMPASS (Connecting, Overcoming, and Moving Past Suicide and Self-Injury)

Self-injurious thoughts and behaviors (SITBs), including suicide, thinking about suicide, and self-injury without intent to die, are major public health crises, with variably effective, and sometimes long and expensive, interventions. SITBs are particularly common in borderline personality disorder (BPD). Moreover, people with BPD often cannot access SITB treatment, drop out of them, and may lose their improvements after them. Reducing SITBs in BPD requires innovative interventions that have greater impact and are faster to deliver. SITBs are particularly influenced by emotion dysregulation (i.e., intense, negative emotion and difficulties changing it) and intimate relationship dysfunction, but leading evidence-based SITB interventions typically focus on the former, while neglecting the latter. For other mental health problems, couple treatments result in comparable or better individual outcomes relative to individually-delivered treatments, with added benefits of enhanced intimate relationship functioning. SITB treatment outcomes in BPD could likely be expedited and optimized with a couple intervention that targets emotion dysregulation in a relational context and intimate relationship dysfunction. This project aims to develop, refine, and test a brief SITB intervention delivered conjointly to individuals with BPD and SITBs (i.e., "patients") and their intimate partners (i.e., "partners")- Sage (formerly known as COMPASS (Connecting, Overcoming, and Moving Past Suicide and Self- injury))- that targets both emotion dysregulation and intimate relationship dysfunction to reduce SITBs and BPD symptoms in the short- and long-term. Prior to formal testing in an uncontrolled trial, it is important to solicit preliminary data regarding the clarity, accessibility, safety, tolerability, and efficacy of Sage. This project involves 3 Phases: translating Sage outlines into a manual (Phase 1); refining Sage (Phase 2); and an uncontrolled pilot trial of Sage (Phase 3). In Phase 1, the three stages of Sage will be manualized to focus on (1) developing a conjoint safety plan to reduce SITB risk, (2) reducing emotion dysregulation and intimate relationship dysfunction, and (3) changing patterns that maintain SITBs. In Phase 2, Sage will be delivered to 5-10 patients with BPD and SITBs and their partners (i.e., 5-10 couples) who will provide feedback about whether Sage is clear, helpful, and useable. This feedback will be used to refine the Sage manual. In Phase 3, the investigators will test whether Sage is safe, initially efficacious, and feasible by administering it to 15-20 patients with BPD and SITB and their partners (i.e., 15-20 couples). The investigators will examine whether Sage results in changes in SITBs and BPD symptoms in patients with BPD and SITBs, and SITB risk factors (e.g., emotion dysregulation and intimate relationship dysfunction) in both patients and partners. These outcomes will be measured multiple times per day during treatment using participant's smartphones (i.e., ecological momentary assessment), and interviews/questionnaires administered at the beginning, middle, end, and at 3 months after the intervention. The investigators predict that Sage will reduce SITBs and BPD symptoms in the patient with BPD and SITBs and improve emotion dysregulation and intimate relationship dysfunction in both patients with BPD and SITBs and their partners. This study offers a novel SITB and BPD treatment that directly targets SITBs, BPD symptoms, and the factors that drive them. Its short duration broadens the accessibility of BPD and SITB interventions with the potential to contribute to reducing SITBs and BPD symptoms on a large scale. During this period of social distancing due to COVID-19, Sage will be delivered remotely via secure videoconferencing (Zoom Healthcare). As social distancing restrictions lift, Sage will be delivered in the laboratory.

Caplyta in Borderline Personality Disorder

The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD). Sixty subjects with BPD will be randomized in a 1:1 fashion to either Caplyta (42mg/day) or matching placebo for 8 weeks of active treatment. The hypothesis to be tested is that Caplyta will result in greater rates of reduction in symptoms of BPD compared to placebo (improvement in symptoms will be indicated by lower scores on established outcome measures of BPD symptoms that have been used in prior studies).

Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics

This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).

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.

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.

The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults

The study will examine behavioral patterns and underlying neural correlates which distinguish patients with borderline personality disorder (BPD) from healthy subjects as they participate in a two-person trust game and will determine whether administration of intranasal oxytocin (OT) will normalize trust game performance and concomitant neural processing in the BPD group.