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

Primary Purpose

Trauma, Psychological, Psychosis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TAU + A comprehensive third-generation intervention
TAU
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma, Psychological focused on measuring Psychosis, Trauma, Psychological Intervention, EMDR

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Carmen ValienteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

TAU + waiting list

TAU + A comprehensive third-generation intervention

Arm Description

Treatment as usual

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
October 26, 2022
Last Updated
November 10, 2022
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05619822
Brief Title
A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms
Acronym
IITG-PPT
Official Title
A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms; Design, Implementation and Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological, Psychosis
Keywords
Psychosis, Trauma, Psychological Intervention, EMDR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU + waiting list
Arm Type
Other
Arm Description
Treatment as usual
Arm Title
TAU + A comprehensive third-generation intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU + A comprehensive third-generation intervention
Intervention Description
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
Intervention Name(s)
TAU
Intervention Description
Treatment as usual
Primary Outcome Measure Information:
Title
Change from posttraumatic symptoms at 12 weeks and 6 months
Description
International Trauma Questionnaire (ITQ; Cloitre, et al., 2018).Higher scores mean a worse outcome.
Time Frame
Change baseline, 12 weeks, and 6 months
Title
Change from psychotic symptoms at 12 weeks and 6 months
Description
Psychotic Symtoms Rating Scale (Haddock et al., 1999).Higher scores mean a worse outcome.
Time Frame
Change baseline, 12 weeks, and 6 months
Title
Change from psychopathological symptoms at 12 weeks and 6 months
Description
Symptom Checklist 45-SCL-90_r brief (Davison et al., 1997). Higher scores mean a worse outcome.
Time Frame
Change baseline, 12 weeks, and 6 months
Title
Change from dissociative symptoms at 12 weeks and 6 months
Description
The Dissociative Experience Scale Taxon (DES-T; Waller & Ross, 1997). Higher scores mean a worse outcome.
Time Frame
Change baseline, 12 weeks, and 6 months
Secondary Outcome Measure Information:
Title
Change from Personal and Social functioning at 12 weeks and 6 months
Description
Personal and Social Performance Scale (PSP; Morosini y cols., 2000). Higher scores mean a worse outcome.
Time Frame
Change baseline, 12 weeks, and 6 months
Title
Change from Wellbeing at 12 weeks and 6 months
Description
Scales of Psychological Well-Being (SPWB; Ryff & Keyes,1995). Higher scores mean a better outcome.
Time Frame
Change baseline, 12 weeks, and 6 months
Title
Change from satisfaction with life at 12 weeks and 6 months
Description
Satisfaction with Life Scale (SWLS; Diener et al., 1985). Higher scores mean a better outcome.
Time Frame
Change baseline, 12 weeks, and 6 months
Title
Change from Attachment at 12 weeks and 6 months
Description
Psychosis Attachment Measure (PAM; Berry et al., 2006; Sheinbaum et al., 2013). Higher scores mean a worse outcome.
Time Frame
Change baseline, 12 weeks, and 6 months
Title
Change from Emotion Regulation at 12 weeks and 6 months
Description
Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski & Kraaij, 2007). Higher scores mean a worse outcome for disfunctional dimensions and a better outcome for functional dimensions
Time Frame
Change baseline, 12 weeks, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Valiente, Ph.D.
Phone
+34913943135
Email
mcvalien@ucm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Espinosa, Ph.D.
Phone
+34913943135
Email
respinosa@ucjc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Valiente, Ph.D.
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Regina Espinosa, Ph.D.
Organizational Affiliation
Universidad Camilo Jose Cela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmen Valiente
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Valiente, P.h.D
First Name & Middle Initial & Last Name & Degree
Regina Espinosa, P.h.D
First Name & Middle Initial & Last Name & Degree
Belen Lozano

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Learn more about this trial

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

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