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45 active trials for Borderline Personality 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
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
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
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
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
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