NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Luis Eduardo Estévez Cachafeiro
Conditions: Psychological Trauma, Stress Disorders, Post-Traumatic; Mental Disorders
Interventions: Trauma-Focused Group Intervention, Treatment as Usual (TAU)
Countries: Spain
Psychological trauma is common and can lead to long-lasting emotional distress, difficulties in daily functioning, and reduced quality of life. Despite the availability of effective psychological treatments, access to trauma-focused interventions in primary care remains limited. This study will evaluate the effectiveness and feasibility of a trauma-focused group intervention delivered within a collaborative stepped-care model in primary care. Adults with trauma-related symptoms will be randomly assigned to either receive the trauma-focused group intervention or treatment as usual. The intervention integrates evidence-informed principles from Eye Movement Desensitization and Reprocessing (EMDR) and Sensorimotor Psychotherapy and is delivered in a structured group format. The study hypothesizes that participants receiving the trauma-focused group intervention will show greater improvements in trauma-related symptoms, emotional regulation, psychological distress, functioning, quality of life, and treatment satisfaction than participants receiving treatment as usual. The study will also evaluate implementation outcomes, including acceptability, feasibility, and participant engagement, to determine whether this intervention can improve access to trauma-focused care within the public healthcare system.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Currently enrolled in the Primary Care Collaborative Program (PCP) of the Sant Andreu Mental Health District. * Diagnosis of post-traumatic stress disorder (PTSD) or the presence of symptoms consistent with trauma-related psychopathology, including PTSD, prolonged stress, complex PTSD (CPTSD), relational trauma, or other trauma-related symptoms associated with adverse life experiences. * Sufficient proficiency in Spanish or Catalan to understand the intervention and complete the study assessments. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Acute psychotic decompensation. * Active suicidal ideation requiring immediate and intensive clinical intervention. * Unstable problematic substance use. * Unstable comorbid severe mental disorder. * Significant cognitive impairment or intellectual or physical disability that would interfere with participation in the group intervention or understanding of the study procedures.
- Barcelona, Barcelona, Spain