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Personality Disorders clinical trials

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NCT ID: NCT06392139 Recruiting - Clinical trials for Other Mental Conditions

Specialized Healthcare Service for BPD Patients: Athens Trial

BPDAS
Start date: January 7, 2022
Phase: N/A
Study type: Interventional

A quasi-experimental pragmatic trial was developed to evaluate a specific health-care service for the treatment of biporal personality disorder (BPD) patients.The effectiveness and economic evaluation (cost-effectiveness and cost-utility) of this specific health-care service as it is offered in every-day clinical practice will be assesed. The main hypothesis of the particular study is that the specific health-care service for the treatment of BPD patients has better efficacy and cost-effectiveness than the treatment as usual. Furthermore, two additional substudies will be performed. The first one is a qualitative study on the experiences of patients and therapists of the specific program as compared to common treatment. The second substudy aims to investigate the effectiveness and the possible psychodynamic functions of the initial outpatient reception clinic of the specific program. Patients will be followed for 2 years.

NCT ID: NCT06367907 Recruiting - Clinical trials for Personality Disorders

Biological Effects of Schema Therapy

BE-ST
Start date: September 9, 2021
Phase: N/A
Study type: Interventional

Background: The major aim of this study is to compare the effects of emotion focused (experiential) and cognitive interventions of schema therapy (ST) on emotion regulation deficits in patients with borderline personality disorder (BPD) according to DSM-V (alternative model) criteria. In a randomized, single-blinded parallel-group design clinical effects as well as effects on neurotransmitter metabolism and connectivity will be compared. Method: While the 9-weeks treatment protocol of particular interest includes emotion focused interventions (ST-EF, n=60) such as chair dialogs, imagery rescripting or role play, the active control condition (ST-AC, n=60) is restricted to cognitive interventions, e.g. psychoeducation or pro/contra discussions. MEGA-PRESS 1H-MR spectroscopy and resting-state functional MR imaging (rs-fMRI) will be used before/after treatment protocols (T0-T1) and 6 months after the end of therapy (T2) to assess the effects on glutamate (Glx) and GABA metabolism in key regions of the target networks (executive control network, ECN: dorsolateral prefrontal cortex, DLPFC; salience network, SN: anteromedial cingulate cortex, aMCC; default mode network, DMN: pregenual cingulate cortex, pgACC) and to investigate the corresponding altered connectivity in these networks. The biological aberrations at T0 as compared to healthy controls (n=60) and treatment effects (at T1 and T2, n≥40 in each condition) on these aberrations will be linked to clinical effects measured by an extensive test battery with particular interest on emotion regulation, and specified by the Reliable Change Index (RCI). For longitudinal data mixed model analysis will be performed. The main questions are (1) whether the emotion regulation deficit and the pattern of BPD-specific symptomatology are associated with a specific pattern of Glx and GABA concentrations in the DLPFC, aMCC and pgACC and corresponding deviations of functional connectivity within the ECN, SN and DMN. Hypothesis: Depending on primary and secondary outcome measures at T0, altered RSFC in the DMN, SN and ECN and corresponding altered Glx or GABA concentrations are assumed. (2) whether both treatment conditions have different clinical effects on the ability to regulate emotions and whether the respective clinical effects are associated with the changes in neurobiological aberrations. Hypothesis: It is hypothesized that the ST-EF condition will improve emotion regulation skills more effectively than the control condition. Only in the ST-EF condition are higher response and remission rates expected in the primary and secondary outcome measures, as well as effects on the ECN, SN and DMN with corresponding changes in RSFC and Glx or GABA concentrations.

NCT ID: NCT06346353 Recruiting - Depression Clinical Trials

Substance Consumption, Personality, and Cognitive Functioning of Chess Players

Start date: January 31, 2024
Phase:
Study type: Observational

The aim of this project is to find out if there is a difference in addictive behavior, personality traits, and cognitive abilities between chess players and non-chess players.

NCT ID: NCT06259851 Recruiting - Clinical trials for Borderline Personality Disorder

rTMS-enhanced Psychotherapy for Borderline Personality Disorder

rTMS-DBT
Start date: August 20, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06219122 Recruiting - Clinical trials for Personality Disorders

The Effectiveness of a Creative Arts en Psychomotor Therapy Intervention for People With Personality Disorders. From Negative Thinking to Positive Doing.

NDPD
Start date: January 31, 2024
Phase: N/A
Study type: Interventional

Mental health consists of the absence of mental disorders and the presence of mental well-being. However; mental health care currently focuses mainly on mental disorders and less on promoting mental well-being. And yet people with personality problems often score very low on well-being. In order to work on sustainable mental health, attention is needed for both mental complaints and well-being and this is achieved through promoting psychological adaptation. Psychological adaptation is the process in which a person deals in a healthy way with their own needs, emotions and inner signals (such as stress) as well as the smaller or larger challenges in life. For people with personality problems psychological adaptation is also low, they mainly react in rigid patterns. Creative arts and psychomotor therapies (CAPTS) are a non-verbal form of therapy in which various creative methods, such as theater, sports, dance, music and sports methods, are used to make contact with emotions and to practice healthier ways of dealing with them. This is very suitable for working on promoting psychological adaptivity, within a safe and playful context. It's about doing and experiencing, and discovering what works for you personally, more than talking and understanding. That this is effective is endorsed by professionals and clients in mental health care, but scientific evidence is still scarce. That is why a specially developed, CAPTS module for people with personality problems will be investigated in a mixed methods design. We focus on both effectiveness and working mechanisms in a Multiple Baseline Single Case Experimental Design and a qualitative approach.

NCT ID: NCT06183333 Recruiting - Depression Clinical Trials

Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current psychiatric diagnosis. Participants will be randomly assigned to either the intervention group, receiving a web-based emotion regulation program, or a waitlist control group, which will have delayed intervention access after eight weeks. The intervention is grounded in cognitive-behavioral therapy (CBT), featuring everyday emotion regulation exercises, and psychoeducation delivered through video and audio files. Outcome measures include emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, evaluated at four and eight weeks post-baseline.

NCT ID: NCT06182787 Recruiting - Schizophrenia Clinical Trials

Development of a Model for Digital Monitoring of the Mental State of the Hospitalized Patient

Start date: May 18, 2022
Phase:
Study type: Observational [Patient Registry]

This study presents the development and validation of a unique Digital Experience Sampling Method (ESM) questionnaire specifically adapted for monitoring changes in the mental state of patients during psychiatric hospitalization. The questionnaire was carefully crafted through focus groups involving patients and clinical staff, ensuring its relevance and applicability to the unique characteristics of mental state changes in a hospitalization setting. To evaluate the validity of the ESM questionnaire, symptom severity trends obtained from the questionnaire will be compared with estimates derived from the Positive and Negative Syndrome Scale (PANSS) assessment. Data will be collected from 100 subjects over a 14-day psychiatric hospitalization period. In addition to the ESM questionnaire, smartwatch sensors will monitor physiological indicators. Feasibility and patient compliance will be assessed by examining patients' willingness to use the digital ESM questionnaires and the smartwatch sensors. The study will also cross-reference self-reported sleep quality and activity levels captured in the ESM questionnaires with objective physiological indicators and nursing staff reports, providing insights into the reliability of the patient-reported data. Furthermore, the study will evaluate the impact of the ESM data on clinical decision-making by physicians throughout the 14-day psychiatric hospitalization period. Patient satisfaction and satisfaction among the multidisciplinary team with the monitoring model will also be assessed. This research underscores the potential of digital technologies to enhance patient-centered care and facilitate informed treatment decisions in psychiatric hospitalization settings.

NCT ID: NCT06106555 Recruiting - Clinical trials for Borderline Personality Disorder

Which Factors Are Relevant for Treatment Outcome in Dialectical Behaviour Therapy for Borderline Personality Disorder?

Start date: September 1, 2023
Phase:
Study type: Observational

The objective of this project is to investigate factors that contribute to the success and lack of success in DBT among individuals with BPD and a history of self-harm in a clinical psychiatric setting. 1. Do certain personality factors and identity disturbance predict the treatment outcome of DBT in individuals with BPD? 2. Do changes in identity disturbance, self-hate, or emotion regulation mediate the treatment outcome of DBT in individuals with BPD? 3. Do specific personality profiles moderate the treatment outcomes of DBT for individuals with BPD? 4. When does the primary treatment effect occur, and does this effect persist after a 12-month follow-up period?

NCT ID: NCT06050486 Recruiting - Clinical trials for Child's Internalizing and Externalizing Problems

A Mentalization-based Intervention for Children of Parent(s) With Borderline Personality Disorder

Start date: September 11, 2023
Phase: N/A
Study type: Interventional

Background and study aims? Parents with borderline personality disorder (BPD) can present parenting difficulties such as expressions of hostility, low sensitivity, and overprotection. These parenting problems are associated with adverse outcomes for the offspring, namely, borderline features, depression, internalizing and externalizing problems, and interpersonal difficulties. Intervention studies with parent(s) who have borderline personality disorder show promising results regarding the improvement of parenting skills and parent-infant relationship. However, very few assess their effect on child's mental health and development. This study aims to evaluate the acceptability, feasibility and preliminary effectiveness of a mentalization-based clinical intervention, directed to school-aged children of mothers and/or fathers with borderline personality disorder, to reduce child mental health problems, in the short- and medium-term. Who can participate? School-aged children (5 to 12 years of age), with mental health problems (CBCL internalizing and/or externalizing scores must be T = 60 or above), and their mothers and/or fathers (> 18 years of age) with subclinical or clinical BPD. What does the study involve? Mother and/or father with BPD complete an online survey and an online interview. If available, the other parent and the child's teacher complete an online survey, separately. The child completes an online task with a researcher's assistance. After, participants are assigned to an intervention group (one arm, pre-posttest study). Participants receive a mentalization-based treatment for children (MBT-C), starting one week after the pre-test. MBT-C is a psychological intervention designed to resolve the child's mental health problems and promote resilience by promoting the child's and parent's mentalizing capacities. It aims to be delivered by a mental healthcare professional trained in MBT-C. In this clinical trial MBT-C will be composed of: 3 assessment sessions; 12 individual sessions with the child, plus 6 parallel individual sessions with the parent with BPD; 1 follow-up family session, 3 months after the last session. Assessment sessions are composed of one family session, one session with the child and one session with the parent. Sessions with child are in-site and sessions with parent can be on-line or in-site, according to the parents' preference. Sessions have a weekly frequency and a 50-60 minutes duration each. One week after the last intervention session participants repeat the same assessments completed before MBT-C. In addition, child and mother and/or father with BPD complete separately an online satisfaction survey and an online interview to assess participants experiences with MBT-C. We expect that after receiving MBT-C the child's mental health problems will have significantly decreased and to obtain information on the feasibility of a future large-scale clinical trial and retrospective acceptability of MBT-C with this specific population. What are the possible benefits and risks of participating? This intervention aims to resolve child's mentals mental health problems. Patients who do not meet the inclusion criteria to participate, do not consent, or withdraw from the trial will be offered a debrief and the possibility of being referred to individualized psychological support or other if needed. If child's mental health problems are not resolve by the end of MBT-C the same possibility will be offered. At the end of MBT-C mother and/or father with BPD will be referred to individual therapy, if needed and not already receiving. Intervention with BPD parents can present challenges, such as ambivalence within the therapeutic relationship (high idealization versus therapist rejection), and high drop-out rates. To overcome these difficulties, the therapist should be knowledgeable about BPD, foster a secure-based relationship with the parent and child, and maintain an empathetic stance. It is possible for parent(s) with BPD to maltreat or abuse their children, in which case child protective services must be contacted and informed. The same procedure must be adopted in case of substantial substance abuse.

NCT ID: NCT06005129 Recruiting - Clinical trials for Borderline Personality Disorder

Personality Change Study for Borderline Personality Disorder

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

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.