Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608706
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
The Key to Integrated Trauma Treatment in Psychosis Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Key to Integrated Trauma Treatment in Psychosis Kit Trial a Pragmatic Multicenter Effectiveness RCT of EMDR for Trauma Symptoms in Schizophrenia Spectrum Disorders
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KIT
Brief Summary:
Schizophrenia spectrum disorders SSDs have a significant trauma etiology trauma has been reported in 65 - 80 in this patient group and have a negative impact on prognosis Trauma treatment is currently not offered in SSDs due to a lack of evidence KIT is a pragmatic trial comparing the effectiveness of added trauma focused therapy Eye Movement Desensitization and Reprocessing EMDR to standard treatment in SSDs
The study will compare EMDR as add on to treatment as usual TAU to TAU in patients with schizophrenia spectrum disorders SSDs The overall aim is to examine the effectiveness of EMDR on trauma symptoms in SSDs
Participants will receive max 26 sessions of EMDR and complete assessments before during and after the course of therapy in addition to a period of time 6 months after therapy to examine long-term effects
The study will compare EMDR as add on to treatment as usual TAU to TAU in patients with schizophrenia spectrum disorders SSDs The overall aim is to examine the effectiveness of EMDR on trauma symptoms in SSDs
Participants will receive max 26 sessions of EMDR and complete assessments before during and after the course of therapy in addition to a period of time 6 months after therapy to examine long-term effects
Detailed Description:
The KIT trial is a pragmatic assessor-blinded parallel 2-group superiority randomized trial comparing the addition of EMDR to treatment as usual TAU versus waiting list WL and TAU for EMDR on symptoms of trauma in patients with SSDs Participants will be randomized 11 block randomization by center and gender to one of the two groups
Aims hypotheses objectives
The primary aim is to investigate the effectiveness of EMDR as an add-on treatment for SSDs in standard clinical practice to target trauma symptoms
The secondary aim is to improve personalized therapy through the exploration of clinical stratification variables that may influence the effectiveness of EMDR
The long-term aim is to guide clinical practice and if shown to be effective to implement EMDR for patients with SSDs
The primary objective EMDR and treatment as usual TAU compared to waiting list WL and TAU will reduce symptoms of trauma as measured by the ITQ the International Trauma Questionnaire in SSDs
The secondary objective Stratification variables trauma profile eg type severity timing gender biomarkers of stress and immune system reactivity digital biomarkers of autonomous stress reactivity influence the effectiveness of EMDR
Expected results during the project period
The EMDR group will show less trauma symptoms compared to the WL control group by the end of treatment and possibly better functioning
No differences for costs nor serious adverse events will emerge between the groups at the end of treatment
Better outcomes are expected for trauma characterized by mild to moderate severity and later onset eg related to experience of psychosis as compared to CT eg abuse and neglect
Although exploratory patients with high levels of inflammation markers andor hyperarousal and autonomous reactivity to trauma benefit most from EMDR
EMDR for psychosis therapists Eighteen trial therapists are currently fully trained in EMDR for psychosis in collaboration with Dr Varese and colleagues at Manchester University and receive monthly supervision At least 24 more will be trained by early 2025 Assuming some therapist drop-out 40 trial therapists will be recruiting SSD patients from their patient lists
Assessments Assessments will be performed for both groups by blinded research personnel at baseline mid-treatment 12 weeks end of treatment 6 months 6- and 12-months post randomisation after end of treatment in addition to digital patient feedback every 2 weeks from baseline to end of treatment at 6 months The follow-up period after end of treatment is to examine long-term effects
Eligible participants will be given initial information verbal web page pamphlets by the trial therapists and then verbal and written information by research staff and asked for informed consent to partake in the trial Primary outcome will be measured by the ITQ a validated measure assessing reliable and clinically significant treatment-related change in trauma symptoms including symptoms of PTSD and complex PTSD used in outpatient clinics in Norway Demographic and clinical information will be supplemented by clinical records and national health registers eg Legemiddel-registeret Kontroll og utbetaling av helserefusjoner Kommunalt pasient og bruker-register Norsk pasientregister Nasjonalt kvalitetsregister for behandling i psykisk for voksne Healthcare costs eg use of all health care health related financial support transportation will be captured by the study nurses at each assessment point and through health registers
Patients experience of trauma symptoms working alliance and recovery will be assessed through Norse Feedback digital self-report The digital assessment of the main outcome trauma symptoms ITQ will be captured every 2 weeks to closely monitor symptom fluctuations while recovery and therapist alliance follow the time points of the study nurse assessments This decentralised assessment is deemed particularly suitable in mental health Assessment of somatic status heartrate weight blood pressure will be supplemented by blood samples of inflammation markers CRP IL6 and S-cortisol and blood samples to the Bergen Psychosis Biobank for later analysis eg IL18 The digital biomarkers heart rate variability respiration rate electro- cardiographyphotoplethysmography activation movement actigraphy and skin conductance electrodermal activity will be measured in-session by BioPoint wristworn biosensor Trial therapists will rate fidelity patient safety related adverse events AE and symptom exacerbation after each session and variables facilitating implementation beforeafter trial participation For symptom-specific items on suicidality psychosis substance abuse and hospitalisations A sub-group of 30 patients will be asked about their experience of the therapy with a qualitative interview after treatment
Work packages Quality of assessments and analysis will be ensured by organising themes in work packages WP headed by national experts WP0 Study management WP1 Clinical outcome WP2 Somatic status and biomarkers WP3 Trauma characteristics WP4 Treatment alliance and user experience WP5 Study imple-mentation WP6 Health economic evaluation
Protocol adherence Hospital Clinical Monitor will ensure protocol implementation and site responsibility The protocol will be adhered to by all trial personnel including trial therapists and local PIs to ensure patient safety and trial quality There will be frequent meetings across sites and written agreements on site responsibility All sites will use electronic report files CRF via Viedoc for patient case report forms
Organization The KIT trial is organized in Bergen Psychosis Research Group BPRG at Haukeland University Hospital BPRG has extensive experience from clinical trials on SSDs ClinicalTrialsgov IDs NCT00932529 NCT01446328 NCT03340909 NCT02597439 NCT02146547
Aims hypotheses objectives
The primary aim is to investigate the effectiveness of EMDR as an add-on treatment for SSDs in standard clinical practice to target trauma symptoms
The secondary aim is to improve personalized therapy through the exploration of clinical stratification variables that may influence the effectiveness of EMDR
The long-term aim is to guide clinical practice and if shown to be effective to implement EMDR for patients with SSDs
The primary objective EMDR and treatment as usual TAU compared to waiting list WL and TAU will reduce symptoms of trauma as measured by the ITQ the International Trauma Questionnaire in SSDs
The secondary objective Stratification variables trauma profile eg type severity timing gender biomarkers of stress and immune system reactivity digital biomarkers of autonomous stress reactivity influence the effectiveness of EMDR
Expected results during the project period
The EMDR group will show less trauma symptoms compared to the WL control group by the end of treatment and possibly better functioning
No differences for costs nor serious adverse events will emerge between the groups at the end of treatment
Better outcomes are expected for trauma characterized by mild to moderate severity and later onset eg related to experience of psychosis as compared to CT eg abuse and neglect
Although exploratory patients with high levels of inflammation markers andor hyperarousal and autonomous reactivity to trauma benefit most from EMDR
EMDR for psychosis therapists Eighteen trial therapists are currently fully trained in EMDR for psychosis in collaboration with Dr Varese and colleagues at Manchester University and receive monthly supervision At least 24 more will be trained by early 2025 Assuming some therapist drop-out 40 trial therapists will be recruiting SSD patients from their patient lists
Assessments Assessments will be performed for both groups by blinded research personnel at baseline mid-treatment 12 weeks end of treatment 6 months 6- and 12-months post randomisation after end of treatment in addition to digital patient feedback every 2 weeks from baseline to end of treatment at 6 months The follow-up period after end of treatment is to examine long-term effects
Eligible participants will be given initial information verbal web page pamphlets by the trial therapists and then verbal and written information by research staff and asked for informed consent to partake in the trial Primary outcome will be measured by the ITQ a validated measure assessing reliable and clinically significant treatment-related change in trauma symptoms including symptoms of PTSD and complex PTSD used in outpatient clinics in Norway Demographic and clinical information will be supplemented by clinical records and national health registers eg Legemiddel-registeret Kontroll og utbetaling av helserefusjoner Kommunalt pasient og bruker-register Norsk pasientregister Nasjonalt kvalitetsregister for behandling i psykisk for voksne Healthcare costs eg use of all health care health related financial support transportation will be captured by the study nurses at each assessment point and through health registers
Patients experience of trauma symptoms working alliance and recovery will be assessed through Norse Feedback digital self-report The digital assessment of the main outcome trauma symptoms ITQ will be captured every 2 weeks to closely monitor symptom fluctuations while recovery and therapist alliance follow the time points of the study nurse assessments This decentralised assessment is deemed particularly suitable in mental health Assessment of somatic status heartrate weight blood pressure will be supplemented by blood samples of inflammation markers CRP IL6 and S-cortisol and blood samples to the Bergen Psychosis Biobank for later analysis eg IL18 The digital biomarkers heart rate variability respiration rate electro- cardiographyphotoplethysmography activation movement actigraphy and skin conductance electrodermal activity will be measured in-session by BioPoint wristworn biosensor Trial therapists will rate fidelity patient safety related adverse events AE and symptom exacerbation after each session and variables facilitating implementation beforeafter trial participation For symptom-specific items on suicidality psychosis substance abuse and hospitalisations A sub-group of 30 patients will be asked about their experience of the therapy with a qualitative interview after treatment
Work packages Quality of assessments and analysis will be ensured by organising themes in work packages WP headed by national experts WP0 Study management WP1 Clinical outcome WP2 Somatic status and biomarkers WP3 Trauma characteristics WP4 Treatment alliance and user experience WP5 Study imple-mentation WP6 Health economic evaluation
Protocol adherence Hospital Clinical Monitor will ensure protocol implementation and site responsibility The protocol will be adhered to by all trial personnel including trial therapists and local PIs to ensure patient safety and trial quality There will be frequent meetings across sites and written agreements on site responsibility All sites will use electronic report files CRF via Viedoc for patient case report forms
Organization The KIT trial is organized in Bergen Psychosis Research Group BPRG at Haukeland University Hospital BPRG has extensive experience from clinical trials on SSDs ClinicalTrialsgov IDs NCT00932529 NCT01446328 NCT03340909 NCT02597439 NCT02146547
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None