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

NCT05619822 | Enrolling By Invitation

• 1 other identifier: SCHIZO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma, Psychological; Psychosis

Keywords

Psychosis; Trauma; Psychological Intervention; EMDR

Outcome Measures

Primary Outcomes (4)

• Change from posttraumatic symptoms at 12 weeks and 6 months

  International Trauma Questionnaire (ITQ; Cloitre, et al., 2018).Higher scores mean a worse outcome.

  Change baseline, 12 weeks, and 6 months

• Change from psychotic symptoms at 12 weeks and 6 months

  Psychotic Symtoms Rating Scale (Haddock et al., 1999).Higher scores mean a worse outcome.

  Change baseline, 12 weeks, and 6 months

• Change from psychopathological symptoms at 12 weeks and 6 months

  Symptom Checklist 45-SCL-90\_r brief (Davison et al., 1997). Higher scores mean a worse outcome.

  Change baseline, 12 weeks, and 6 months

• Change from dissociative symptoms at 12 weeks and 6 months

  The Dissociative Experience Scale Taxon (DES-T; Waller \& Ross, 1997). Higher scores mean a worse outcome.

  Change baseline, 12 weeks, and 6 months

Secondary Outcomes (5)

• Change from Personal and Social functioning at 12 weeks and 6 months

  Change baseline, 12 weeks, and 6 months

• Change from Wellbeing at 12 weeks and 6 months

  Change baseline, 12 weeks, and 6 months

• Change from satisfaction with life at 12 weeks and 6 months

  Change baseline, 12 weeks, and 6 months

• Change from Attachment at 12 weeks and 6 months

  Change baseline, 12 weeks, and 6 months

• Change from Emotion Regulation at 12 weeks and 6 months

  Change baseline, 12 weeks, and 6 months

Study Arms (2)

TAU + waiting list

OTHER

Treatment as usual

Behavioral: TAU

TAU + A comprehensive third-generation intervention

EXPERIMENTAL

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.

Behavioral: TAU + A comprehensive third-generation intervention

Interventions

TAU + A comprehensive third-generation intervention BEHAVIORAL

This is a individual intervention with with a total of 12 sessions: Session 1. Constructing the Therapy Experience. Session 2. Life history and immediate reactions to trauma. Session 3. Preparing to deal with trauma. Session 4. Regulating emotions. Session 5-9. Focusing on retelling and processing the traumatic event (EMDR PHASES\_PHASE 3: Evaluation of the traumatic memory. EMDR PHASE 4: Desensitization. EMDR PHASE 5: Positive Belief Installation. PHASE 6: Body Scan). Session 9. Re-evaluating traumatic memory and self-care through positive emotions. Session 10. Cultivating self-kindness. Session 11. Developing a healthy identity. Session 12. Building a better future

TAU + A comprehensive third-generation intervention

TAU BEHAVIORAL

Treatment as usual

TAU + waiting list

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Carmen Valiente

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Psychological Trauma; Psychotic Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Carmen Valiente, Ph.D.

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

• Regina Espinosa, Ph.D.

  Universidad Camilo Jose Cela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 17, 2022
• Study Start: May 27, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (1)