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

Sponsor

Universidad Complutense de Madrid (Other)

Overall Status

Recruiting

CT.gov ID

NCT05619822

Collaborator

(none)

100

Enrollment

Location

Arms

37.1

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma, Psychological Psychosis	Behavioral: TAU + A comprehensive third-generation intervention Behavioral: TAU	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 27, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 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 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

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 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 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.
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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carmen Valiente	Pozuelo de Alarcón	Madrid	Spain	28223

Sponsors and Collaborators

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