A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms
Launched by UNIVERSIDAD COMPLUTENSE DE MADRID · Nov 10, 2022
Trial Information
Current as of November 11, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is testing a new, comprehensive therapy for adults who have both psychosis or psychotic symptoms and trauma-related PTSD. People are randomly assigned to either the usual care they would receive (TAU) plus a trauma-psychosis treatment, or to TAU with a waiting list. The new program follows three stages: build safety and a good therapeutic relationship, revisit and process the traumatic memories, and help people reconnect with others and life. It’s delivered as about a dozen 90-minute individual sessions, combining approaches like ACT, mindfulness, EMDR, and positive psychology. Researchers will look to see if this approach reduces trauma and psychotic symptoms and improves overall functioning and well-being.
Who can join and what to expect: the study is for adults aged 18–65 who have a psychotic-spectrum disorder or a mood disorder with psychotic symptoms, and who also meet criteria for PTSD (they’ll need to speak Spanish). People are screened to see if they’re at higher risk for PTSD, and there are a few exclusions (recent significant substance use problems or serious cognitive issues). If eligible, you’ll be randomly assigned to the new therapy plus TAU or to TAU with a waiting list. Assessments happen at start, around 12 weeks, and at 6 months, using standard measures of PTSD symptoms, psychotic symptoms, daily functioning, well-being, life satisfaction, and emotion regulation. The trial is taking place in Madrid, Spain, and results aren’t available yet; it’s expected to complete in 2026.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- Those showing a high risk of PTSD (TSQ ≥6) will be further evaluated to determine whether they meet the inclusion criteria. Participants must:
- • Be between the ages of 18 and 65 fluent enough in Spanish language;
- • Meet the criteria for a diagnosis of a psychotic spectrum disorder or a mood disorder with psychotic symptoms according to MINI (Sheeman et al., 1997);
- • Meet PTSD diagnostic criteria according to the Clinician-Administered PTSD Scale (CAPS; Blake et al., 1995)
- Exclusion Criteria:
- • Those who have a diagnosis of substance or alcohol abuse or dependence in the 30 days prior to participation in the study
- • To have a severe neurocognitive problems or brain damage that interfere with the basic processing of information in psychotherapy.
About Universidad Complutense De Madrid
The Universidad Complutense de Madrid (UCM) is a prestigious academic institution renowned for its commitment to research and innovation in various fields, including health sciences. As a prominent sponsor of clinical trials, UCM leverages its extensive resources and expertise to advance medical knowledge and improve patient outcomes. The university fosters collaboration among researchers, clinicians, and industry partners, ensuring the highest standards of ethics and scientific rigor in its clinical research initiatives. UCM's dedication to education and research excellence positions it as a leader in the development of new therapeutic interventions and health solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pozuelo De Alarcón, Madrid, Spain
Patients applied
Trial Officials
Carmen Valiente, Ph.D.
Principal Investigator
Universidad Complutense de Madrid
Regina Espinosa, Ph.D.
Principal Investigator
Universidad Camilo Jose Cela
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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