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NCT07450105
The prevalence of self-harm and suicidal behavior among adolescents has increased dramatically over the past two decades-a fourfold rise that represents both a severe personal burden and a substantial public health challenge. Dialectical Behavior Therapy for Adolescents (DBT-A) is the gold-standard treatment; however, the standard 20-week format is resource-intensive and time-consuming, which limits accessibility. An intensive 4-week DBT (I-DBT) program has been developed that may improve access and reach a larger number of adolescents. The investigators now seek to evaluate its feasibility and preliminary outcomes. The investigators will assess the feasibility of I-DBT in two to three adolescent groups comprising a total of 8-12 participants and their caregivers in spring and autumn 2026, examining recruitment, feasibility, and outcome measures such as self-harm, suicide attempts, acute hospital admissions, depression, and quality of life, as well as treatment dropout. The investigators aim to use the feedback to make necessary adjustments before broader testing of the I-DBT intervention.
NCT06458933
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.
NCT02387736
Standard one-year dialectical behaviour therapy (DBT), which has four components, is an effective treatment for people with borderline personality disorder. However, such DBT programs are in short supply and costly, resulting in long wait lists. In practice, DBT is often reduced in length or intensity. This study will determine whether shorter DBT treatment is clinically effective and cost-effective. In total, 240 self-harming BPD patients will be randomly assigned to receive either 1 year or 6 months of DBT, with follow-up lasting two years. Rates of suicidal and self-harm behaviours, use of health care and general psychological functioning will be examined.
NCT06222411
The aim of the study is to evaluate the impact of organizational interventions for physician development on wellbeing, and investigate wellbeing and other characteristics of physicians with and without formal leadership roles.
NCT07460947
This study tests a new treatment for people with borderline personality disorder (BPD). The treatment combines a medication called D-cycloserine with one day of transcranial magnetic stimulation (TMS). The main questions it aims to answer are: * How many participants complete the treatment? * How do participants feel about the treatment? * Does the treatment have neurophysiological changes on participants? * Does the treatment improve BPD symptoms? * Do the benefits last over time? Participants will be asked to: * Come to the clinic for interviews and testing * Complete weekly questionnaires for 4 weeks before the treatment day * Take D-cycloserine the night before treatment * Attend one treatment day at the clinic. On that day, they may receive up to 20 short TMS sessions (each lasting 3 minutes and separated by 30 minutes). This visit may last up to 12 hours. * Complete weekly questionnaires for 6 weeks after the treatment day.
NCT07065071
The investigators would like to find out if Mentalization-Based Therapy (MBT) is effective for people aged 60+ who struggle in relationships. The study aims to understand whether MBT helps older people to build better relationships and feel better about themselves. There is currently no research with people over 60 and MBT, yet MBT is being offered to the older adult population by NHS trusts throughout the UK without evidence for its effectiveness. As well as developing knowledge about how MBT can help at this point in life, the study aims to improve the quality of care offered. MBT targets mentalization, which is the ability to make sense of one's own and other people's thoughts, feelings, actions and beliefs. Current research suggests that the ability to mentalize changes over the lifespan and may be influenced by many factors, some of which are specific to later life. For example, changes in relationships during later life and biological changes in the brain may impact mentalization systems. The investigators would also like to understand what difficulties MBT may be effective for in later life. The diagnosis of borderline personality disorder (BPD), which MBT was developed to treat, was, until recently, assumed to disappear with age. However, growing evidence suggests that symptoms change, rather than disappear. Given these unknowns, the study will use a Hermeneutic Single-Case Efficacy Design (HSCED). Up to six participants, up to six people who know the participants, and clinicians delivering the MBT interventions will be recruited. Data in the form of questionnaires, self-report and therapy documents will be gathered, and everyone will be interviewed. For each participant, the data will be used to compile both an affirmative (yes, MBT was effective) case, and a sceptic case (no, MBT was not effective). Cases will then be reviewed by an adjudication panel comprising one service user expert by experience, one MBT expert and one expert in another therapeutic modality. For each case, each expert will decide if the affirmative or sceptic case was more likely. Finally, findings will be synthesised and used to draw conclusions about the effectiveness of MBT. The HSCED lends itself to theory-building, as it gathers in-depth data from individuals and facilitates comparison within and between cases. Further, participants' contribution to their own 'rich case record' through change interviews recognises people as taking an active role in their own healing.
NCT05712057
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.
NCT06675461
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 treatment for patients with BPD in ED settings, however a 4-session treatment for people with personality disorders in ED settings was tested in Australia and showed promising results in reducing health care use and improving symptoms. A recent pilot feasibility randomized controlled trial (RCT) comparing this 4-session treatment to treatment as usual was conducted at the Centre for Addiction and Mental Health and preliminary findings have shown that the treatment is feasible to deliver and acceptable to both patients and clinicians. The proposed fully powered RCT will build on this pilot data to assess the efficacy 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 emergency health care use and improving BPD symptoms, functioning and quality of life.
NCT06251908
Health institutes call for psychosocial interventions and recovery-oriented approaches as supplement to pharmacological treatment for mental health disorders. Participatory art interventions have been suggested to be promising in promoting recovery by stimulating connectedness, hope, renegotiation of identity, participatory meaning-making and empowerment. Moreover, cognitive literature studies suggest there might be potential benefits of engaging with literature in terms of improved cognition and social cognition. In spite of promising findings, the evidence base is still thin. We have developed REWRITALIZE (REWR), a manualised, recovery-oriented fifteen-session participatory creative writing group intervention, led by a professional author and attended by a mental health professional. The intervention comprises introduction to literary forms, spontaneous writing on those forms, sharing texts and engaging in reflective discussions about them. It is designed to provide a holding and non-stigmatising environment. The aim of the present study is to evaluate REWR for persons with severe mental illness. This study is a randomised controlled clinical trial (RCT) with an embedded pilot RCT focusing on clinical and personal recovery. This study is an investigator-initiated, randomised, two-arm, single-blinded, multi-center, waiting list trial. Participants (n=266) with severe mental illness (\>18 yrs.) will be recruited at six psychiatric centres in region Zealand and randomised to active (creative writing group + treatment as usual) or control (waiting list + treatment as usual) condition. Assessments will be collected pre- and post-intervention and six months after end of intervention. The primary outcome measure will be the questionnaire of the process of recovery administered at the end of the intervention. Secondary outcome measures comprise measures of recovery, self-efficacy and mentalising assessed at the end of the intervention and six months after the intervention ends. The post-intervention measures will be compared between active and control groups by means of independent sample t-tests. The pilot RCT will focus on a subset of participants (n=70) with schizophrenia spectrum disorders (18-35 yrs), evaluating exploratory outcome measures related perspective-taking, social cognition, cognitive function, psychosocial functioning, and symptom level.
NCT04432129
The purpose of this study is to investigate the efficacy of an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression, stress, anxiety, personality- and functional disorders in Denmark
NCT07342907
Borderline Personality Disorder (BPD) involves intense emotional ups and downs, unstable relationships, impulsivity, and a poor sense of self. These challenges often lead to addiction, self-harm, and frequent use of healthcare services. While certain treatments already in practice - such as dialectical behavior therapy - can help, they don't work for everyone or address all aspects of the disorder. This study plans to explore internal family systems (IFS) therapy, a method that views the mind as made up of different "parts" - each with its own thoughts and feelings. IFS helps people build understanding and compassion toward these parts and connect with a calmer, more centered "Self." This may be especially useful for those with BPD, who often feel fragmented and extremely critical of themselves and others. This will be the first study to examine internal family systems therapy for BPD. The participants (15 in total) will receive up to 50 individual sessions over 15 months. Changes in symptoms and overall mental health will be measured at four points during the study. People with lived experience of BPD will help shape the research to ensure it is relevant, respectful, and useful for others facing similar challenges.
NCT07292155
Cervical myofascial pain syndrome is a chronic musculoskeletal condition characterized by the presence of sensitive trigger points and taut muscle bands, resulting in localized or referred pain, muscle stiffness, and limited range of motion. The disorder frequently leads to functional limitations and a reduction in quality of life. Although the physical features of cervical myofascial pain syndrome have been well documented, its psychological and social dimensions have not been adequately explored. Personality traits and social factors may influence pain perception, coping mechanisms, and treatment adherence. Type D personality, also known as distressed personality, is defined by the coexistence of negative emotions and social inhibition and has been associated with worse outcomes in various chronic diseases. Stigma represents another psychosocial factor that may contribute to disability and emotional distress in chronic pain conditions. This case-control study aims to investigate the prevalence of Type D personality traits and anticipated stigma among patients with cervical myofascial pain syndrome compared with healthy individuals. The study further explores the relationships between personality type, stigma, and clinical and psychological parameters, including anxiety, depression, disability, and health-related quality of life. Findings are expected to support a more comprehensive, biopsychosocial understanding of cervical myofascial pain syndrome and emphasize the importance of psychological screening and social support in clinical management.
NCT07292064
This study aimed to investigate the relationship between Type D personality traits, somatization disorder, and perceived social support in individuals diagnosed with temporomandibular joint disorders. Temporomandibular joint disorders are musculoskeletal and neuromuscular conditions that affect the jaw joint, chewing muscles, and related structures, leading to pain and functional difficulties. Psychological and social factors, such as personality traits and emotional distress, have been shown to influence the development and persistence of these disorders. The research was conducted as a prospective cross-sectional study between February and June 2025 in Gaziantep City Hospital. Adult participants between 18 and 65 years of age who were diagnosed with temporomandibular joint disorders were compared with healthy individuals of similar age and gender. Participants completed validated questionnaires that assessed mandibular function, anxiety and depression symptoms, Type D personality traits, somatization tendencies, and levels of perceived social support. The purpose of this study was to provide a more comprehensive understanding of the psychological and social dimensions that may contribute to the onset and course of temporomandibular joint disorders.
NCT05913544
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).
NCT07197502
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.
NCT02751632
A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a step-wise clinical approach for the treatment of ultra high risk patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.
NCT06606002
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.
NCT06471010
This study aims to explore the feasibility, acceptability, and effectiveness of a new blended psychotherapeutic treatment program based on Dynamic Interpersonal Therapy (B-DIT) for adult clients with personality pathology. Blended interventions have the potential to improve treatment accessibility and cost-effectiveness for individuals with personality pathology and promote a sense of agency and ownership among clients regarding their treatment as compared to traditional Face-to-Face (FTF) approaches. This may improve treatment outcome and recovery. The B-DIT intervention, developed collaboratively by Dutch mental health care institute De Viersprong and OnlinePsyHulp, integrates FTF therapy and online modules into a cohesive treatment program. The program spans three phases: an individual phase lasting approximately two months, followed by a four-month group phase, and concluding with a four-month booster phase to reinforce positive changes. Face-to-face therapy sessions and online treatment modules are utilized alternately and complementarily throughout all treatment phases. The primary study aims are (1) to monitor and evaluate the feasibility of B-DIT; which includes evaluating client satisfaction, treatment drop-out rates, user parameters related to online modules, and an interview-based qualitative analysis of therapists' and clients' experiences; and (2) to gather initial effectiveness data based on Routine Outcome Monitoring (ROM) measurements, complemented by a Single Case Experimental Design (SCED). The research questions are as follows: 1. How acceptable is the blended treatment program, B-DIT, for adult clients with personality pathology and their therapists? 2. What is the effectiveness of B-DIT for adult clients with personality pathology in terms of progress in reducing symptom burden, overall functioning, and personality functioning, including changes in process measures such as mentalizing ability, epistemic trust, and agency? 3. Exploratively, the effects on these process and outcome measures across treatment phases will be compared to ascertain if observed changes align with the presumed working mechanisms of the intervention.
NCT04296604
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.
NCT07123974
Many individuals living with borderline personality disorder (BPD) have experienced childhood trauma, such as abuse or neglect. A significant number of them also meet the criteria for post-traumatic stress disorder (PTSD). However, standard psychotherapies often do not address both conditions at the same time, which can affect treatment outcomes. A research team in Germany developed and validated a 45-week individual psychotherapy that has shown promising results for individuals coping with both BPD and PTSD. It has already been adapted and offered in English-speaking settings such as Toronto and Boston. This study aims to adapt this therapy into French in Quebec. Over 24 months, we will conduct a mixed-methods observational study to evaluate changes in symptoms (BPD, PTSD, and other comorbidities) and in daily functioning.