The Key to Integrated Trauma Treatment in Psychosis Trial
Recruiting · NCT06608706 · Interventional (participants receive a specific treatment) · Lead sponsor: Haukeland University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- aged ≥ 16 years
- diagnosis of F20-29 in the ICD-10 assessed using SCID 5 CV
- reporting trauma \> 1 month prior to assessment
- 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)
- able and motivated for engaging in trauma focused (TF) therapy
- able to understand and give informed consent; consent capacity for psychological treatment choices and consent to study procedures.
Exclusion criteria
- primary diagnosis of substance use/alcohol dependence
- inability to understand spoken Norwegian
- organic psychosis or a neurological disorder
- acute state of psychosis defined as:
- hospitalized in an acute ward the last 6 weeks or
- major change in antipsychotic medication type or started/stopped antipsychotic medication last 6 weeks or
- other mental health crises last 6 weeks
- current or previous (past 6 months) TF therapy
Where it is running
11 locations listed.
- Haukeland University Hospital - Bergen, Norway
- Betanien DPS - Bergen, Norway
- Solli DPS - Bergen, Norway
- Voss DPS Bjørkeli - Bergen, Norway
- Helse Fonna HF - Haugesund, Norway
- Diakonhjemmet Hospital - Oslo, Norway
- Oslo University Hospital - Oslo, Norway
- Helgeland Hospital HF - Sandnessjøen, Norway
- Stavanger University Hospital - Stavanger, Norway
- UNN - Tromsø, Norway
- St. Olav Hospital - Trondheim, Norway