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

Not Applicable

• Conditions: Trauma, Psychological; Psychosis
• Interventions: Behavioral: TAU + A comprehensive third-generation intervention; Behavioral: TAU

• Registration Number: NCT05619822
• Lead Sponsor: Universidad Complutense de Madrid

Brief 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.

Detailed 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 Timeline

• Study Start: 2022-05-27
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-04-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU + A comprehensive third-generation intervention	TAU + A comprehensive third-generation intervention	he protocol will bedeveloped following the three stages of recovery from trauma (Herman, 2015): 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 administered in 11 90-minute individual sessions per week, combining strategically ACT, Mindfulness, EMDR as well as Positive Psychology interventions.
TAU + waiting list	TAU	Treatment as usual

Primary Outcome Measures

Name	Time	Method
Change from psychopathological symptoms at 12 weeks and 6 months	Change baseline, 12 weeks, and 6 months	Symptom Checklist 45-SCL-90_r brief (Davison et al., 1997). Higher scores mean a worse outcome.
Change from posttraumatic symptoms at 12 weeks and 6 months	Change baseline, 12 weeks, and 6 months	International Trauma Questionnaire (ITQ; Cloitre, et al., 2018).Higher scores mean a worse outcome.
Change from psychotic symptoms at 12 weeks and 6 months	Change baseline, 12 weeks, and 6 months	Psychotic Symtoms Rating Scale (Haddock et al., 1999).Higher scores mean a worse outcome.
Change from dissociative symptoms at 12 weeks and 6 months	Change baseline, 12 weeks, and 6 months	The Dissociative Experience Scale Taxon (DES-T; Waller \& Ross, 1997). Higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change from Wellbeing at 12 weeks and 6 months	Change baseline, 12 weeks, and 6 months	Scales of Psychological Well-Being (SPWB; Ryff \& Keyes,1995). Higher scores mean a better outcome.
Change from Attachment at 12 weeks and 6 months	Change baseline, 12 weeks, and 6 months	Psychosis Attachment Measure (PAM; Berry et al., 2006; Sheinbaum et al., 2013). Higher scores mean a worse outcome.
Change from Personal and Social functioning at 12 weeks and 6 months	Change baseline, 12 weeks, and 6 months	Personal and Social Performance Scale (PSP; Morosini y cols., 2000). Higher scores mean a worse outcome.
Change from Emotion Regulation at 12 weeks and 6 months	Change baseline, 12 weeks, and 6 months	Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski \& Kraaij, 2007). Higher scores mean a worse outcome for disfunctional dimensions and a better outcome for functional dimensions
Change from satisfaction with life at 12 weeks and 6 months	Change baseline, 12 weeks, and 6 months	Satisfaction with Life Scale (SWLS; Diener et al., 1985). Higher scores mean a better outcome.

Trial Locations

Locations (1)

Carmen Valiente; 🇪🇸 Pozuelo de Alarcón, Madrid, Spain