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New treatment option for Psychiatric Diagnosis
Official title The Key to Integrated Trauma Treatment in Psychosis Trial
ClinicalTrials.gov ID: NCT06608706
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join 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...
- able and motivated for engaging in trauma focused (TF) therapy
You likely can't join 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
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Norway
- Haugesund, Norway
- Oslo, Norway
- Sandnessjøen, Norway
- Stavanger, Norway
- Tromsø, Norway
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Norway; Haugesund, Norway; Oslo, Norway; Sandnessjøen, Norway; Stavanger, Norway; Tromsø, Norway and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.