Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID06608706

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

On this page

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

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

Actively Recruiting

2

Betanien DPS

Bergen, Norway

Actively Recruiting

3

Solli DPS

Bergen, Norway

Actively Recruiting

4

Voss DPS Bjørkeli

Bergen, Norway

Actively Recruiting

5

Helse Fonna HF

Haugesund, Norway

Actively Recruiting

6

Diakonhjemmet Hospital

Oslo, Norway

Actively Recruiting

7

Oslo University Hospital

Oslo, Norway

Actively Recruiting

8

Helgeland Hospital HF

Sandnessjøen, Norway, 8800

Actively Recruiting

9

Stavanger University Hospital

Stavanger, Norway

Actively Recruiting

10

UNN

Tromsø, Norway

Actively Recruiting

11

St. Olav Hospital

Trondheim, Norway

Actively Recruiting

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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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