A Comprehensive Third-generation Intervention for People With Psychosis &

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

This study is a randomized clinical trial at psychiatric rehabilitation services of the Public Network of Care for people with serious mental disorders. We hypothesize that participants receiving the intervention, in comparison with controls, will show a reduction in general, PTSD and psychotic symptomatology, an improvement in levels of functioning and well-being, a greater ability to regulate emotions with more help-seeking behaviours. Given the complexity of both psychosis and PTSD and the reluctance of professionals to treat it, we plan to develop a precise comprehensive protocol. In order to address all issues associated with both psychosis and comorbid PTSD, the protocol will be developed following the three stages of recovery from trauma: first, focusing on establishing the therapeutic alliance and safety; second, focusing on recounting and re-processing the traumatic event; and third, focusing on reconnecting with others and with life despite the trauma experienced. The therapy will be adapted to the characteristics of people with SMD and administered in 11 90-minute individual sessions per week, combining strategically ACT, Mindfulness, EMDR as well as Positive Psychology interventions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05619822
Study type	Interventional
Source	Universidad Complutense de Madrid
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	May 27, 2022
Completion date	June 30, 2025

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms — IITG-PPT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms