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The Key to Integrated Trauma Treatment in Psychosis Trial: A Randomized Study of EMDR Therapy for Trauma Symptoms in Schizophrenia Spectrum Disorders
Led by Haukeland University Hospital · Updated on 2026-04-24
187
Participants Needed
11
Research Sites
52 weeks
Total Duration
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Sponsors
H
Haukeland University Hospital
Lead Sponsor
H
Helgeland Hospital Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy as an add-on treatment for trauma symptoms in patients with schizophrenia spectrum disorders (SSDs). Trauma is common in this group and negatively affects prognosis, but trauma treatment is not currently standard due to limited evidence. This pragmatic, assessor-blinded, randomized trial compares EMDR plus treatment as usual (TAU) to TAU alone, aiming to reduce trauma symptoms and improve personalized therapy approaches. Participants will be randomly assigned to receive up to 26 sessions of EMDR designed specifically for psychosis, alongside their usual treatments, or to continue with TAU as a waiting list control for six months. EMDR therapy includes eight flexible phases targeting trauma memory reprocessing with adaptations for psychosis-related challenges. The study includes careful monitoring of trauma symptoms, psychosis severity, autonomic arousal, and inflammation markers throughout treatment and follow-up. Participants will complete assessments at baseline, mid-treatment (12 weeks), end of treatment (6 months), and at 6- and 12-months post-randomization to evaluate long-term effects. Digital self-reports, blood samples, biosensor measurements during sessions, and clinical records will be used to track symptoms, safety, and treatment adherence. The primary outcome is trauma symptom change measured by the International Trauma Questionnaire (ITQ). Additional measures include psychosis symptoms, stress biomarkers, and patient experience. The total study duration for each participant covers at least 12 months of follow-up.
CONDITIONS
Brief Title
The Key to Integrated Trauma Treatment in Psychosis Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 16 years or older
- Diagnosed with schizophrenia spectrum disorder (ICD-10 codes F20-F29) using SCID 5 CV
- Experienced trauma more than 1 month ago
- Currently distressed by trauma with a score of 5 or higher on item 21c of the Trauma and Life Events Checklist (TALE)
- Able and motivated to engage in trauma-focused therapy
- Able to understand and give informed consent for treatment and study procedures
You will not qualify if you...
- Primary diagnosis of substance use or alcohol dependence
- Unable to understand spoken Norwegian
- Organic psychosis or neurological disorder
- Acute psychosis defined by recent hospitalization, major medication changes, or mental health crises within the last 6 weeks
- Current or previous trauma-focused therapy within the past 6 months
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either EMDR therapy for psychosis added to their usual treatment or continue with treatment as usual and waiting list control. EMDR involves up to 26 therapy sessions targeting trauma symptoms with specific adaptations for psychosis.
Up to 26 therapy sessions and assessments at baseline, mid-treatment (12 weeks), and end of treatment (6 months)
Duration - 6 months
Participants are monitored after treatment completion to assess long-term effects on trauma symptoms and overall functioning.
Assessments at 6 and 12 months post-randomisation
Trial Site Locations
Total: 11 locations
1
Haukeland University Hospital
Bergen, Norway, 5009
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2
Betanien DPS
Bergen, Norway
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3
Solli DPS
Bergen, Norway
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4
Voss DPS Bjørkeli
Bergen, Norway
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5
Helse Fonna HF
Haugesund, Norway
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6
Diakonhjemmet Hospital
Oslo, Norway
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7
Oslo University Hospital
Oslo, Norway
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8
Helgeland Hospital HF
Sandnessjøen, Norway, 8800
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9
Stavanger University Hospital
Stavanger, Norway
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10
UNN
Tromsø, Norway
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11
St. Olav Hospital
Trondheim, Norway
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Research Team
E
Else-Marie Løberg, PhD, Professor
N
Nina Mørkved, PhD, Assoc. Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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