The Key to Integrated Trauma Treatment in Psychosis Trial

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 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 (1:1, 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 e.g. 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 (e.g. related to experience of psychosis) as compared to CT (e.g. abuse and neglect). * Although exploratory, patients with high levels of inflammation markers and/or 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 signific Покажи пълното описание...

Inclusion Criteria: 1. aged ≥ 16 years 2. diagnosis of F20-29 in the ICD-10 assessed using SCID 5 CV 3. reporting trauma \> 1 month prior to assessment 4. being currently distressed by the reported trauma(s), i.e., ≥ 5 (from 0 = not at all, to 10 = extremely) on item 21c on the Trauma and Life Events Checklist (TALE) 5. able and motivated for engaging in trauma focused (TF) therapy 6. able to understand and give informed consent; consent capacity for psychological treatment choices and consent to study procedures. Exclusion Criteria: 1. primary diagnosis of substance use/alcohol dependence 2. inability to understand spoken Norwegian 3. organic psychosis or a neurological disorder 4. acute state of psychosis defined as: 1. hospitalized in an acute ward the last 6 weeks or 2. major change in antipsychotic medication type or started/stopped antipsychotic medication last 6 weeks or 3. other mental health crises last 6 weeks 5. current or previous (past 6 months) TF therapy