Comparing EMDR therapy with standard treatment for trauma in schizophrenia

The Key to Integrated Trauma Treatment in Psychosis (Kit) Trial: A Pragmatic, Multicenter Effectiveness RCT of EMDR for Trauma Symptoms in Schizophrenia Spectrum Disorders

This study tests if adding EMDR therapy to standard treatment can help people with schizophrenia who have experienced trauma feel better and function well.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 187 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Haukeland University Hospital (Academic / other)
• Locations: 11 sites (Bergen and 10 other locations)
• Trial ID: NCT06608706 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) as an additional treatment for patients with schizophrenia spectrum disorders (SSDs) who have experienced trauma. Participants will be randomly assigned to receive either EMDR therapy alongside standard treatment or standard treatment alone, with assessments conducted before, during, and after the therapy. The study aims to determine if EMDR can significantly reduce trauma symptoms and improve overall functioning in this patient population. Additionally, it seeks to identify factors that may influence the effectiveness of EMDR in treating trauma symptoms.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16 and older with a diagnosis of schizophrenia spectrum disorders who have experienced trauma and are currently distressed by it.

Not a fit: Patients with primary substance use disorders, acute psychosis, or those unable to understand spoken Norwegian may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new therapeutic option for reducing trauma symptoms in patients with schizophrenia spectrum disorders.

How similar studies have performed: While the use of EMDR in treating trauma is established, this specific application in schizophrenia spectrum disorders is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Bergen and 10 other locations

• Haukeland University Hospital — Bergen, Norway (Recruiting)
• Betanien DPS — Bergen, Norway (Recruiting)
• Solli DPS — Bergen, Norway (Recruiting)
• Voss DPS Bjørkeli — Bergen, Norway (Recruiting)
• Helse Fonna HF — Haugesund, Norway (Recruiting)
• Diakonhjemmet Hospital — Oslo, Norway (Recruiting)
• Oslo University Hospital — Oslo, Norway (Recruiting)
• Helgeland Hospital HF — Sandnessjøen, Norway (Recruiting)
• Stavanger University Hospital — Stavanger, Norway (Recruiting)
• Unn — Tromsø, Norway (Recruiting)
• St. Olav Hospital — Trondheim, Norway (Recruiting)

Study contacts

• Study coordinator: Else-Marie Løberg, PhD, Professor

Conditions Psychiatric Diagnosis; Schizophrenia Disorders; Psychological Trauma, Historical; Psychosis; EMDR; Trauma treatment; Schizophrenia spectrum disorders; Childhood trauma