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

A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms; Design, Implementation and Effectiveness

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Psychosis; Trauma, Psychological
• Intervention / Treatment: Behavioral: TAU; Behavioral: TAU + A comprehensive third-generation intervention

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Carmen Valiente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TAU + waiting list; Treatment as usual	Behavioral: TAU; Treatment as usual
Experimental: 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.	Behavioral: TAU + A comprehensive third-generation intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Carmen Valiente, Ph.D., Universidad Complutense de Madrid; Principal Investigator: Regina Espinosa, Ph.D., Universidad Camilo Jose Cela

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Psychosis; Psychological Intervention; Trauma; EMDR
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Psychotic Disorders; Mental Disorders; Psychological Trauma
• Other Study ID Numbers: SCHIZO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No