Clinical Research Directory

Efficacy of "DBT-LIVE", an Identity Skills Training Program, for Borderline Personality Disorder.

The main objective of this project is to adapt and evaluate the LIVE Skill module in the Spanish population. LIVE Skill is a psychological intervention protocol specifically designed to address identity disturbances in individuals with Borderline Personality Disorder (BPD). The project aims to examine its effectiveness in reducing identity disturbances, emotional regulation difficulties, and suicidal behavior, as well as in improving self-compassion, meaning in life, and personality functioning. In addition, the efficiency and feasibility of the program will be assessed by evaluating its acceptability among both patients and professionals, and its dissemination will be promoted to maximize its clinical impact. The methodology includes a sample of approximately 112 individuals diagnosed with BPD, recruited through the Valencian Association for Personality Disorders (ASVA-TP), who will be allocated into two groups. The project is structured into five studies. First, a qualitative pilot feasibility study will be conducted with approximately 30 participants through focus groups and interviews in order to refine the intervention protocol. The second study will describe the randomized clinical trial protocol, including the interventions and assessment procedures. Subsequently, a randomized controlled trial (RCT) will be carried out, comparing LIVE Skill with treatment as usual (TAU), with assessments conducted at pre-treatment, post-treatment, and six-month follow-up. Following the trial, a qualitative evaluation will be undertaken to identify treatment facilitators and barriers. Finally, the psychometric validation of the questionnaires used in the study will be conducted. The protocol will collect sociodemographic data and measures of identity, emotional regulation, self-compassion, meaning in life, suicidal ideation and behavior, personality functioning, as well as treatment acceptability and feasibility. Participants will provide informed consent and complete an initial assessment to confirm eligibility according to the inclusion and exclusion criteria.

Caring for Caregivers of Individuals With Alzheimer's Disease

What is this study about? This study is called the EMBRACE Study - A Virtual Community Empowerment Approach Integrating Tradition and Technology for Family Caregivers of Individuals with Alzheimer's Disease. It tests whether a home-based virtual exercise program can reduce depression and anxiety in family caregivers of people living with Alzheimer's disease and related dementias (ADRD). Why is this study needed? Caring for a loved one with ADRD is demanding and is strongly linked to depression and anxiety. Regular exercise is one of the most effective ways to reduce these symptoms - but caregivers often cannot leave home to exercise due to the needs of their loved one, transportation concerns, and safety issues. What does participation involve? Participants will be randomly assigned (like a coin flip) to one of two groups: * EMBRACE group: 24 weekly virtual group exercise sessions over 3 months (about 1 hour each), using an at-home elliptical device provided by the study. Months 4-6 include weekly check-in calls to support independent exercise. Educational sessions on habit-building and goal-setting are included. * Wait-list control group: Completes the same surveys and measurements; receives the program after data collection ends. Who can join? Adults (18+) who are the primary unpaid caregiver for someone with ADRD, can read and speak English, and are healthy enough to exercise. Participants do not need to leave home - everything is virtual. What is being measured? Exercise time (using a wearable device), symptoms of depression and anxiety, and whether the program is feasible and acceptable to participants. Where is the study based? Indiana University Indianapolis. The study is conducted entirely virtually and remotely.