NCT06608706

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Sep 2024Dec 2028

Study Start

First participant enrolled

September 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

September 6, 2024

Last Update Submit

April 21, 2026

Conditions

Psychological Trauma, HistoricalPsychiatric DiagnosisSchizophrenia Disorders

Keywords

PsychosisEMDRTrauma treatmentSchizophrenia spectrum disordersChildhood traumaPsychological traumaPTSD

Outcome Measures

Primary Outcomes (1)

  • Trauma symptoms

    Primary outcome is trauma symptoms as measured by the International Trauma Questionnaire. PTSD symptom scale range from 0 to 24. Higher scores indicate more sever trauma symptoms.

    From baseline to end of treatment at 6 months.

Secondary Outcomes (3)

  • Severity of psychosis symptoms

    From baseline to end of treatment at 6 months.

  • The rate of autonomic arousal during trauma processing

    Baseline to end of treatment at 6 months.

  • Inflammation

    Baseline and end of treatment at 6 months

Other Outcomes (5)

  • Clinical stratification by trauma type and severity measured by the Childhood Trauma Questionnaire

    Baseline to end of treatment at 6 months.

  • Adverse events

    Baseline to end of treatment at 6 months.

  • Health care costs

    Baseline to end of treatment at 6 months.

  • +2 more other outcomes

Study Arms (2)

Trauma-focused therapy: EMDR for psychosis and treatment as usual (TAU)

EXPERIMENTAL

Patients randomized to receive max. 26 sessions of EMDR for psychosis.

Other: Eye Movement Desensitization and Reprocessing (EMDR) for psychosis

Treatment as usual (TAU) and waiting list (WL)

NO INTERVENTION

Patients randomized to continue with treatment as usual (TAU) for 6 months as a waiting list (WL) control group. TAU consists of an individual combination of treatments for SSDs in line with Norwegian national guideline (e.g. medication, cognitive therapy, work training, music therapy).

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) for psychosisOTHER

EMDR aims to treat and process trauma by safely retrieving the trauma memories while taxing the working memory. EMDR targets trauma symptoms through memory reprocessing of traumatic memories, and consists of eight flexible phases: history taking/case conceptualization; preparation for memory reprocessing; assessment/identification of a target memory; desensitization/reprocessing; installation of positive cognition; body scan; closure; and re-evaluation. EMDR in the current trial has psychosis-specific adaptations including focus on psychoeducation, preparation for reprocessing and patient safety. Techniques targeting dissociation, psychotic symptoms and psychosis-related challenges are included.

Trauma-focused therapy: EMDR for psychosis and treatment as usual (TAU)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Haukeland University Hospital

Bergen, 5009, 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, 8800, Norway

RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

UNN

Tromsø, Norway

RECRUITING

St. Olav Hospital

Trondheim, Norway

RECRUITING

Related Links

MeSH Terms

Conditions

Mental DisordersSchizophreniaHistorical TraumaPsychotic DisordersPsychological TraumaStress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Else-Marie Løberg, PhD, Professor

CONTACT

4798094420else.marie.loberg@helse-bergen.no

Nina Mørkved, PhD, Assoc. Professor

CONTACT

4792286165nina.morkved@helgelandssykehuset.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (Professor, PhD, Psychologist)

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 23, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

This is not feasible due to Norwegian policies in clinical research.

Locations

NO(11)