Trauma, PsychologicalIITG-PPTNCT05619822
A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms
A study testing TAU + A comprehensive third-generation intervention and TAU in people with Trauma, Psychological and Psychosis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma, Psychological, Psychosis
- What is being tested?
- TAU + A comprehensive third-generation intervention and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 27 May 2022to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- TAU + A comprehensive third-generation intervention, TAU
- Keywords
- Psychosis, Trauma, Psychological Intervention, EMDR
- Medical subject headings
- Psychological Trauma, Psychotic Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU + A comprehensive third-generation interventionBehavioural
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
TAUBehavioural
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| TAU + waiting list | Other | Treatment as usual Receives: 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. Receives: Behavioral: TAU + A comprehensive third-generation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from posttraumatic symptoms at 12 weeks and 6 months
International Trauma Questionnaire (ITQ; Cloitre, et al., 2018).Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change baseline, 12 weeks, and 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change baseline, 12 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start27 May 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Valiente, Ph.D., Principal investigator, Universidad Complutense de MadridRegina Espinosa, Ph.D., Principal investigator, Universidad Camilo Jose Cela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619822
- Sponsor's protocol ID
- SCHIZO
- Acronym
- IITG-PPT
- Status last verified
- Apr 2025
- First submitted
- 26 Oct 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms; Design, Implementation and Effectiveness
- ClinicalTrials.gov ID
- NCT05619822
- Acronym / sponsor ID
- IITG-PPT / SCHIZO
- Conditions
- Trauma, Psychological, Psychosis
- Keywords
- Psychosis, Trauma, Psychological Intervention, EMDR
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + waiting list | Other | Behavioral: TAUTreatment as usual |
| TAU + A comprehensive third-generation intervention | Experimental | Behavioral: TAU + A comprehensive third-generation interventionhe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAU + A comprehensive third-generation interventionThis 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 | Behavioural | TAU + A comprehensive third-generation intervention |
| TAUTreatment as usual | Behavioural | TAU + waiting list |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Change from Personal and Social functioning at 12 weeks and 6 months
Time frame: Change baseline, 12 weeks, and 6 months
Change from Wellbeing at 12 weeks and 6 months
Time frame: Change baseline, 12 weeks, and 6 months
Change from satisfaction with life at 12 weeks and 6 months
Time frame: Change baseline, 12 weeks, and 6 months
Change from Attachment at 12 weeks and 6 months
Time frame: Change baseline, 12 weeks, and 6 months
Change from Emotion Regulation at 12 weeks and 6 months
Time frame: Change baseline, 12 weeks, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Related trials for Trauma, Psychological
Recruiting
Neurobiological Markers of Non-suicidal Self-injury and Treatment Mechanisms of Adolescent Self-injury Intervention Skills Training
Non-suicidal Self-injury (NSSI), Adolescent
RecruitingObservational study
Early Life Stress and Depression: Molecular and Functional Imaging
Depression, Trauma, Psychological
Recruiting
Trauma-Informed Yoga Intervention in Young Women
Trauma, Young Adult Females
Recruiting
Heat and Mental Health - PART 2
Depressed Mood, Young Adults
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmen Valiente, Ph.D. principal investigator
Universidad Complutense de Madrid
Regina Espinosa, Ph.D. principal investigator
Universidad Camilo Jose Cela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAU + A comprehensive third-generation intervention and TAU in people with Trauma, Psychological and Psychosis, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from posttraumatic symptoms at 12 weeks and 6 months (time frame: Change baseline, 12 weeks, and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.