Status:
RECRUITING
The Key to Integrated Trauma Treatment in Psychosis Trial
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
Helgeland Hospital Trust
Conditions:
Psychiatric Diagnosis
Schizophrenia Disorders
Eligibility:
All Genders
16+ years
Phase:
NA
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 curr...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT06608706
Start Date
September 1 2024
End Date
December 31 2028
Last Update
September 23 2024
Active Locations (2)
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1
Haukeland University Hospital
Bergen, Norway, 5009
2
Helgeland Hospital HF
Sandnessjøen, Norway, 8800