NCT06608706 The Key to Integrated Trauma Treatment in Psychosis Trial
| NCT ID | NCT06608706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Psychiatric Diagnosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 187 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 187 participants in total. It began in 2024-09-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06608706 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Psychiatric Diagnosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06608706 currently recruiting?
Yes, NCT06608706 is actively recruiting participants. Contact the research team at else.marie.loberg@helse-bergen.no for enrollment information.
Where is the NCT06608706 trial being conducted?
This trial is being conducted at Bergen, Norway, Bergen, Norway, Bergen, Norway, Bergen, Norway and 7 additional locations.
Who is sponsoring the NCT06608706 clinical trial?
NCT06608706 is sponsored by Haukeland University Hospital. The trial plans to enroll 187 participants.