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Patient Engagement in PTSD Treatment (PEP)

RecruitingNAAges 18 Years - anyAllHerlev and Gentofte Hospital
NCT06755710 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical study is to improve the outcome of outpatient PTSD treatment at two clinics treating majority ethnic Danes and refugees with PTSD respectively. The study will consist of two similar randomized controlled trials. The main questions the study aims to answer are: * Does an added motivation enhancement module as a precursor for PTSD treatment reduce dropout and increase treatment outcome? * Does an added Shared Decision-Making session which facilitate individualized treatment yield a superior outcome compared to PTSD treatment and PTSD treatment supplemented by motivation enhancement? Participants are recruited at two different clinics, Psychotherapeutic Unit (PU) and Competence Centre for Transcultural Psychiatry (CTP). At PU the participants are randomized to one of two arms, and at CTP to one of three arms. One arm is the control group where participants will

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📋 Eligibility rules (as published)
In- and exclusion criteria of the randomised controlled trial for Psychotherapeutic Unit Inclusion Criteria: * Adults (18 years or older) * PTSD pursuant to the ICD-10 research criteria * Signed informed consent * patients referred to "Main Level" treatment Exclusion Criteria: * Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression. * Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26). In- and exclusion criteria of the randomised controlled trial for Competencecenter of Transcultural Psychiatry: Inclusion criteria: * Adult (18 years or older) * Refugees or persons who have been family reunified with a refugee * PTSD pursuant to the ICD-10 research criteria * Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nations' definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences. * Signed informed consent Exclusion criteria: * Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression. * Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).
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What it tests

  • Introductory PTSD module
  • Shared Decision Making
  • Treatment as Usual
  • Standardised treatments
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Where

1 site
Mental Health Centre Ballerup
Ballerup Municipality, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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