300,000+ clinical trials. Find the right one.

45 active trials for Borderline Personality Disorder

A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder

This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study. Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.

Start: November 2020

French Adaptation of the AIDA (Assessment of Identity Development in Adolescence) and LoPF-Q (Levels of Personality Functioning Questionnaire) Scales.

The main objective of this study is to develop the French version of the two questionnaires AIDA and LoPF-Q. The secondary objective is to investigate the links between disrupted development of identity and adolescent psychopathology. To participate in the study, patients will have to complete online or paper versions of the questionnaires AIDA-LoPF and other assessments of personality and general psychopathology (BB5, SDQ). Parents will have to answer complete the parent version of the SDQ questionnaire. The BPFSC-11, which is a clinician-rated assessment, will be completed in a subgroup of patients, by the same healthcare professional, in order to assess the concurrent validity. The investigators will also add the clinical diagnoses according to ICD-10 found in the medical record.

Start: January 2021

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 disorder (MDD) and borderline personality disorder (BPD).

Start: June 2021

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 Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), in inpatients diagnosed with borderline personality disorder in a major depressive episode.

Start: June 2021

DBT Skills Plus EMDR for BPD and Trauma

Borderline Personality Disorder (BPD) is a severe disorder that frequently co-occurs with post-traumatic stress disorder (PTSD). The comorbidity of BPD and PTSD is more disabling, predicting lower rates of BPD remission. Dialectical behavioral skills training (DBT-ST), is a group-delivered training that covers four types of skills: emotion regulation, mindfulness, interpersonal effectiveness and distress tolerance. As a stand-alone treatment, research suggest that DBT-ST is an efficacious treatment for BPD. In parallel, EMDR has emerged in last years as an efficacious approach to adult trauma. However, so far, the efficacy of EMDR to treat trauma in populations with BPD diagnosis has not been tested. The present pilot randomized-controlled clinical trial aims to test whether a combination of DBT-ST plus EMDR could be efficacious to treat trauma in individuals with BPD. 40 participants will be recruited from the BPD Unit at the Hospital de la Santa Creu I Sant Pau (Barcelona, Spain) and will be randomized (1:1) to DBT-ST + EMDR or DBT-ST alone. The primary outcome will be the reduction of PTSD symptoms. In addition, symptom-related variables will be collected before and after the interventions. This will be the first study to test the combination of DBT-ST and EMDR.

Start: May 2021

NEUROIMAGING OF ADOLESCENT BORDERLINE PERSONALITY DISORDER WITH AND WITHOUT POST-TRAUMATIC STRESS DISORDER

Borderline personality disorder (BPD) is a common mental disorder in adolescents with significant individual and societal repercussions, characterized over the long term by emotional hyperresponsiveness, relational instability, identity disturbances and self-aggressive behavior. The etiology of BPD is multifactorial and involves exposure to traumatic life events, which are present in the majority of cases. This explains the very common co-morbidity between BPD and post-traumatic stress disorder (PTSD), which involves emotionally painful memory relapses of one or more traumatic events, associated with an emotional trauma avoidance syndrome (s). ) and hypervigilance. Brain imaging studies in adolescents with BPD have shown decreases in the volume of gray matter within the frontolimbic network, as well as a decrease in frontolimbic white matter bundles. These brain changes are considered to be biological markers of TPB. However, the exact same brain changes are seen in PTSD. Although it represents more than a third of adolescents hospitalized in psychiatry, neuroscientific studies of BPD in adolescence are still scarce. The expertise we have acquired in U1077 in adolescents with PTSD offers us an exceptional opportunity to characterize in BPD with and without PTSD structural anomalies, including the hippocampus, and functional at rest, never used for hour in the teenager's BPD. Beyond that, carrying out an 18-month follow-up of the patients will allow us to assess the predictive value of these anomalies on the level of general psychopathology in all the patients studied and the intensity of the symptoms of traumatic relapse in the patients with PTSD. This modeling of disorders integrating psychopathological, neuropsychological and neuroanatomical approaches will provide the clinician with new knowledge necessary for therapeutic innovation.

Start: June 2021

Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder

This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.

Start: January 2020

Effectiveness of a Short and Telematic Version of Cognitive-behavioral Treatment for Borderline Personality Disorder

Standard Dialectical Behavioral Therapy (DBT)is an effective treatment for Borderline Personality Disorder (BPD), particularly for patients with significant behavioral and affective dysregulation, including suicidality. However, DBT in its original format is delivered in 12 months, and even though currently there are shorter versions of the treatment being developed and tested, in the context of public mental health care in Chile a shorter, intensive and lighter version of the treatment is likely needed to help patients seeking help for BPD symptoms. This study will test whether a 3 month, intensive and simplified version of DBT is at least equivalent to standard six months DBT with all its components (skills training, individual therapy, coaching calls, and treatment-team consulting). 120 patients diagnosed with BPD we'll be randomly assigned to receive either the short, intensive 3-month intervention or the longer standard 6-month DBT intervention. Baseline measures will be taken pre-treatment, upon treatment completion, and at a 4-month follow-up. Session-to-session change in BPD symptoms will also be measured throughout the treatments. Primary outcomes for the study are BPD symptoms, frequency, and intensity of suicidal activity. Secondary outcome measures include depression scores, quality of life, and ER visits, and days in inpatient care.

Start: November 2021

A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

There are currently no pharmacological treatments approved to treat borderline personality disorder (BPD). This trial will be conducted to evaluate the efficacy and safety of brexpiprazole for the treatment of subjects diagnosed with BPD to provide a pharmacological treatment for BPD.

Start: October 2019

Treating Self Injurious Behavior: A Novel Brain Stimulation Approach

The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). NSSI is the deliberate attempt to harm oneself, most often through cutting or burning, without suicidal intent. NSSI is a maladaptive emotion-regulation strategy often triggered by negative emotions, especially those involving feelings of rejection. tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes. Several studies have demonstrated its effectiveness in treating an array of conditions, depending on electrode placement, including depression and chronic pain. tDCS may also facilitate adaptive emotion regulation; researchers have also successfully used tDCS to reduce negative emotions and aggressive responses to social rejection. The investigators therefore seek to explore tDCS as a potential treatment for NSSI. This pilot feasibility study seeks 1) to examine how at-home, self-administered tDCS is tolerated in a sample of individuals who engage in frequent NSSI; 2) to gather pilot data regarding changes in emotional and neural responses during a social task after a series of tDCS sessions in this clinical population of individuals who engage in NSSI; 3) to gather pilot data on the effects of tDCS on NSSI behaviors and urges. The investigators seek to recruit a sample of 22 individuals who engage in frequent NSSI to complete all study procedures. Individuals will be randomized to receive active- or sham-tDCS for two twenty-minute applications on each of six alternating days over approximately two weeks. Participants will be trained on tDCS self-administration, which will be supervised during each session over a videoconferencing platform by a researcher. Functional MRI (fMRI) may be performed at baseline and again after the completion of 12 sessions of tDCS. Subjects' NSSI and urges to engage in NSSI will be recorded for four weeks in real-time, using an iPod- based system that reminds subjects to stop at certain times during the day to record their thoughts, feelings, and behaviors. This will allow measurement of NSSI urges and behaviors for one week before, two weeks during, and one week after the tDCS intervention. The long-term goal of this study is to identify a novel form of treatment for NSSI and to better understand NSSI pathophysiology.

Start: October 2019

Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)

Posttraumatic Stress Disorder (PTSD) and Borderline Personality Disorder (BPD) are two mental health conditions that often occur together (i.e., PTSD-BPD), with comorbidity rates as high as 58%. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require that participants cease all suicidal behaviours prior to treatment. Furthermore, no integrated treatment has been innovated to address the specific mechanisms underpinning this comorbidity. We propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy (CPT) plus Suicide Risk Management (SRM), as a briefer (12 sessions) and more efficient treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this uncontrolled study is to collect initial safety and efficacy data on this adapted treatment. Knowledge gleaned from this study will have significant direct clinical implications. Potential risks of the study include individual distress, suicide risk, and residual PTSD and BPD symptoms post-treatment. To minimize risk, study therapists will closely monitor participants using the suicide risk assessment and management protocol. Using this protocol, if participants remain distressed after a therapy session or psychological interview they will be encouraged to discuss their distress with their study assessor or therapist and coached to implement strategies to reduce their distress. If they express self-harming or suicidal urges the study assessor or therapist will implement a standardized protocol to monitor and address any escalations in risk. Potential benefits of this study include reductions in participants' PTSD, BPD and other mental health symptoms. Additionally, the study may benefit others by improving the treatment repertoire for PTSD-BPD with a more succinct treatment that can also be utilized for individuals with suicidal behaviours.

Start: September 2021

Trial of a Brief Psychological Intervention for Suicidal Patients With Borderline Personality Disorder in the Emergency Department

When in crisis, people with borderline personality disorder (BPD) frequently seek care in emergency departments (EDs) often presenting with suicide and self-harm behaviour. There is no established evidence-based brief intervention for patients with BPD in ED settings, however a 4-session psychotherapeutic intervention for people with personality disorders in ED settings was tested in Australia and showed promising results in reduced health care utilization. The proposed pilot randomized controlled trial will assess the feasibility of delivering this 4-session intervention in the ED for people with BPD who present with suicidal ideation or self-harm with the aim of reducing health care utilization.

Start: April 2021

Measuring the Impact of Real Time fMRI Neurofeedback in Borderline Personality Disorder

This study will test the impacts of real time fMRI neurofeedback in patients with Borderline Personality Disorder. This is a pilot study in a small number of people enrolled in clinical programs at Yale New Haven Hospital.

Start: November 2020

Dialectical Behavior Therapy vs Enhanced Usual Care for Suicidal and Self-harming Adolescents. 10 Year Follow-up

The purpose of the study is to evaluate the long-term efficacy of dialectical behavior therapy (DBT) in treatment of adolescents with deliberate self harm compared to enhanced usual care (EUC). This study follows-up 77 patients in the ages of 12-18 yrs who have been included in an RCT of DBT-A vs EUC. The main inclusion criterion for this study was repetitive self-harm behaviour. The patients were randomly allocated to receive 16 weeks of outpatient DBT or EUC in child and adolescent psychiatric clinics in Oslo. Participants have been assessed so far on six different time-points: baseline (before starting treatment), 9 weeks, 15 weeks, 19 weeks, 71 weeks and 3 years after start of the treatment. In the current project patients will be assessed a 7th time 10 years after treatment completion. It is hypothesized that compared with participants who had received EUC in the original trial during their adolescence participants who had received DBT-A will: A) report a significantly lower frequency of episodes of self-harm, both last year and over the extended 10-year follow-up interval. B) be significantly less impaired with respect to social, family and occupational functioning and report a higher quality of life. C) have retained significantly fewer diagnostic criteria of BPD and have less severe borderline features according to dimensional measures and have significantly fewer signs of emotion dysregulation.

Start: September 2021

Mapping Aspects of Psychotherapy in Dialectical Behavior Therapy

Although dialectical behavior therapy (DBT) skills training is effective in the treatment of borderline personality disorder, it contains four skills modules and there is little research to guide their modular application. This study compares the unique effects of two distinct DBT skills training modules, relative to a non-DBT therapy group for adults with borderline personality disorder. Using innovative laboratory-based assessment methods, the proposed study will examine the effects of these conditions on emotional responding and interpersonal functioning, as well as clinical outcomes.

Start: October 2020

Application of a Positive Psychology Program for the Development of Emotional Skills in Prison

Studies show that emotional competence plays a significant role in psychological and physical health, and that programs aimed at their development are effective. Can a positive psychology program aimed at the development of emotional competence be implemented as part of care in lieu of deprivation of liberty? The investigators hypothesize the interest and possibility of implementing an emotional skills development program in the specific context of custodial care. The main expected outcome of this study is the identification of necessary adaptations of the emotional skills development program of Kotsou, I. et al (2011) for its implementation in remand homes.

Start: January 2021

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")- 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 COMPASS. This project involves 3 Phases: translating COMPASS outlines into a manual (Phase 1); refining COMPASS (Phase 2); and an uncontrolled pilot trial of COMPASS (Phase 3). In Phase 1, the three stages of COMPASS 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, COMPASS 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 COMPASS is clear, helpful, and useable. This feedback will be used to refine the COMPASS manual. In Phase 3, the investigators will test whether COMPASS 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 COMPASS 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 COMPASS 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, COMPASS will be delivered remotely via secure videoconferencing (Zoom Healthcare). As social distancing restrictions lift, COMPASS will be delivered in the laboratory.

Start: January 2021

Magnetic Seizure Therapy for the Treatment of Borderline Personality Disorder

Suicide is a major public health crisis for which effective new interventions are needed. An innovative new brain stimulation technique called magnetic seizure therapy (MST) shows promise for treating suicidal thinking in chronically depressed individuals. Using a high-risk cohort of suicidal patients with borderline personality disorder (BPD) and treatment resistant major depressive disorder (MDD), this study will evaluate the effectiveness of MST for reducing suicidality and depressive symptoms in an open-label clinical trial of up to 15 treatment sessions. Based on research showing that functioning of the dorsolateral prefrontal cortex (DLPFC) may be disrupted in BPD and place individuals at risk for suicide, the DLPFC will be targeted for stimulation. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.

Start: October 2017

Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder

Theory of mind is one of the features of mentalization. It can be defined as the ability to predict or explain other's behavior with the assignment of beliefs, wishes, and intentions and knowing how to discriminate them with our own, or in other words to know how other people think. Although this ability is crucial to behave adequately in a complex environment, theory of mind judgments are not always optimal. Notably, individuals with borderline personality disorder are may have difficulties to infer other people's thought and state of mind as well as their own mental states. These aspects could be at the origin of symptoms like impaired and unstable relationships, identity disruption and excessive fear of abandonment. Clinical and scientific point suggest that this struggle can be reinforced by social exclusion. Our study aims at identifying if a situation of social exclusion (compared with social inclusion) may decrease theory of mind performance in borderline personality disorder. Participants will play a virtual ball-tossing game on a computer, which can lead to a situation of social inclusion or exclusion. Before and after that, they will perform theory of mind tests with visual material. The study will address three research questions: Q1: Is theory of mind performance lowered after social exclusion, compared with social inclusion? Q2: is the self-reported mentalization skills correlated with theory of mind performances? Q3: Is the social rejection sensitivity correlated with the the theory of mind performances ? The investigators make several hypotheses related to the previous research questions: Q1: the investigators expect social exclusion will decrease the subject's theory of mind performances. Q2: the investigators expect low mentalization skills are correlated to low theory of mind performances. Q3: the investigators expect that a high social rejection sensitivity will be correlated with low theory of mind performances.

Start: June 2019

Effect of Repeated Transcranial Magnetic Stimulation on Aggressive Impulsive Behavior in Patients With Borderline Personality Disorder in a Social Exclusion Paradigm.

Patients with a main diagnosis of borderline personality disorder will be recruited and will be randomized for the application of low frequency repeated transcranial magnetic stimulation (rTMS) protol or sham rTMS protocol. A pre-treatment and post-treatment measurement of the severity of BPD symptoms, impulsivity, and aggressive behavior will be carried out in all participants using self-administered questionnaires. All participants will be asked to participate in a passing ball game (Cyberball) with the intention of investigating aspects related to social inclusion / exclusion and measurements will be made regarding planning using the maze test. Participation in the Cyberball and the assessment of the planning will be carried out before and after the application of the treatment protocol.

Start: January 2021