Maule

This research investigates the use of trauma-focused cognitive behavioral therapy for complex presentations (TF-CBT-CP) delivered through videoconference to adults diagnosed with post-traumatic stress disorder (PTSD) or complex PTSD (CPTSD). The study aims to evaluate how feasible and acceptable this videoconference therapy is for patients treated at community mental health services and hospitals in the Maule Region of Chile. The study also explores participant satisfaction, reasons for refusal or dropout, and the therapy's impact on PTSD and CPTSD symptoms, depression, anxiety, emotional regulation, and psychological well-being. Participants will receive TF-CBT-CP therapy consisting of 16 weekly sessions lasting 60 minutes each, delivered via videoconference. The treatment includes clinical assessments, psychoeducation, coping strategy development, behavioral activation, emotional regulation and interpersonal skills training, exposure to traumatic memories, cognitive interventions, and relapse prevention. Therapy will be provided by trained clinical psychologists with weekly supervision to ensure fidelity to the protocol. Sessions and evaluations will take place in clinical settings equipped with necessary technology to support videoconferencing. Participants will be involved in initial assessments, treatment sessions, and follow-up evaluations at 16 and 20 weeks after starting treatment. Assessments include interviews and questionnaires measuring PTSD and CPTSD symptoms, depression, anxiety, suicidal ideation, alcohol use, emotional regulation, and functioning. Participant satisfaction and acceptability will be evaluated through questionnaires and telephone interviews. The study will monitor feasibility indicators such as eligibility, recruitment, participation, retention, dropout, and completion rates throughout the study period.

Researchers are evaluating the safety and effectiveness of paltusotine compared to a placebo in adults with carcinoid syndrome caused by well-differentiated neuroendocrine tumors. This Phase 3, randomized, double-blind, placebo-controlled study aims to further understand the safety, efficacy, and how the body processes paltusotine in these patients. Participants will be randomly assigned to receive either paltusotine or a placebo during a 16-week double-blind treatment period. The study includes a screening phase lasting up to 11 weeks, followed by a long-term open-label extension lasting 104 weeks, and concludes with a 4-week follow-up period. Paltusotine is taken orally once daily, and the study compares its effect to a matching placebo. During the study, participants will track the number of flushing episodes they experience each day in a diary to assess treatment effectiveness. Researchers will monitor safety and efficacy through regular assessments, including symptom recording and clinical evaluations throughout all study phases. The total participation time spans up to nearly 3 years, allowing for extended observation of long-term safety and benefits.