Patient Engagement in PTSD Treatment (PEP)
Launched by MENTAL HEALTH SERVICES IN THE CAPITAL REGION, DENMARK · Dec 23, 2024
Trial Information
Current as of July 05, 2025
Recruiting
Keywords
ClinConnect Summary
The Patient Engagement in PTSD Treatment (PEP) clinical trial is studying how to improve treatment outcomes for people suffering from PTSD (Post-Traumatic Stress Disorder) and depression. The trial is taking place at two clinics: one mainly treating ethnic Danes and the other focusing on refugees. Researchers are exploring whether adding a motivation enhancement program before the standard PTSD treatment can help more people stick with their treatment and achieve better results. They are also looking at whether involving patients in decisions about their treatment leads to better outcomes.
To participate in this trial, you need to be an adult (18 years or older) diagnosed with PTSD. If you are a refugee or have family ties to one and have experienced severe trauma outside of Denmark, you may also be eligible. Each participant will receive treatment for 8 to 13 months, which may include standard care, motivation enhancement sessions, or sessions where you can discuss and choose your treatment plan with your doctor. This trial is currently recruiting, and it aims to provide valuable insights into how to make PTSD treatments more effective and personalized.
Gender
ALL
Eligibility criteria
- • 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).
About Mental Health Services In The Capital Region, Denmark
The Mental Health Services in the Capital Region of Denmark is a leading clinical trial sponsor dedicated to advancing psychiatric research and improving mental health care delivery. Operating within a robust healthcare framework, the organization focuses on innovative treatment methodologies and evidence-based practices, collaborating with multidisciplinary teams to conduct rigorous clinical trials. By prioritizing patient-centered outcomes and leveraging cutting-edge technology, the Mental Health Services aim to enhance therapeutic interventions and contribute to the global understanding of mental health disorders. Their commitment to research excellence fosters a culture of continuous improvement and collaboration, ultimately striving to elevate the standards of mental health services in the region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ballerup, Capital Region, Denmark
Patients applied
Trial Officials
Jessica Carlsson
Study Chair
Mental Health Services in th Capital Region, Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported