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Enrolling by Invitation

NCT Number: NCT05619822

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

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.

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Key information

Conditions

Trauma, Psychological Mental Disorders Psychological Trauma Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmen Valiente

Pozuelo de Alarcón, Madrid, 28223, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

Treatment as usual

Primary outcomes

  1. Change from posttraumatic symptoms at 12 weeks and 6 months

    Time frame: Change baseline, 12 weeks, and 6 months

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

  2. Change from psychotic symptoms at 12 weeks and 6 months

    Time frame: Change baseline, 12 weeks, and 6 months

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

  3. Change from psychopathological symptoms at 12 weeks and 6 months

    Time frame: Change baseline, 12 weeks, and 6 months

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

  4. Change from dissociative symptoms at 12 weeks and 6 months

    Time frame: Change baseline, 12 weeks, and 6 months

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

Secondary outcomes

  1. Change from Personal and Social functioning at 12 weeks and 6 months

    Time frame: Change baseline, 12 weeks, and 6 months

    Personal and Social Performance Scale (PSP; Morosini y cols., 2000). Higher scores mean a worse outcome.

  2. Change from Wellbeing at 12 weeks and 6 months

    Time frame: Change baseline, 12 weeks, and 6 months

    Scales of Psychological Well-Being (SPWB; Ryff & Keyes,1995). Higher scores mean a better outcome.

  3. Change from satisfaction with life at 12 weeks and 6 months

    Time frame: Change baseline, 12 weeks, and 6 months

    Satisfaction with Life Scale (SWLS; Diener et al., 1985). Higher scores mean a better outcome.

  4. Change from Attachment at 12 weeks and 6 months

    Time frame: 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.

  5. Change from Emotion Regulation at 12 weeks and 6 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: IITG-PPT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2022
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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