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

NCT ID: NCT05619822

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-27
• Study Completion Date: 2026-07-30

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.

Conditions

Trauma, Psychological; Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TAU + waiting list

Treatment as usual

Group Type: OTHER

TAU

Intervention Type: BEHAVIORAL

Treatment as usual

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.

Group Type: EXPERIMENTAL

TAU + A comprehensive third-generation intervention

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

TAU

Treatment as usual

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Valiente, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Regina Espinosa, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad Camilo Jose Cela

Locations

Carmen Valiente

Pozuelo de Alarcón, Madrid, Spain

Countries

Spain

Other Identifiers

SCHIZO

Identifier Type: -

Identifier Source: org_study_id