NCT05619822Enrolling by invitation
A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms
A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms; Design, Implementation and Effectiveness
Source: ClinicalTrials.gov · Last updated 25 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Existing data suggest that both trauma and Post-Traumatic Stress Disorder (PTSD) are very common among individuals with psychosis. The presence of PTSD symptoms in psychosis is associated with worse clinical outcomes and poorer social functioning. However, PTSD is a poorly attended and poorly studied condition among this population. Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when psychotic comorbidity is present. Recent systematic reviews of psychological interventions for trauma in psychosis found that are effective in reducing trauma symptoms, suggesting that they should be implemented in front-line services. Nonetheless, larger confirmative trials are required to form robust conclusions.The aim of this project is to examine the efficacy of comprehensive third-generation protocol for people with comorbid trauma and psychosis.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 26 Oct 2022
- Start date
- 27 May 2022
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Universidad Complutense de Madrid
- Diseases
- Schizophrenia
- NCT number
- NCT05619822
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 27 May 2022 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who have a diagnosis of substance or alcohol abuse or dependence in the 30 days prior to participation in the study
Other
- To have a severe neurocognitive problems or brain damage that interfere with the basic processing of information in psychotherapy.
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carmen Valiente Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.