Actively Recruiting
Patient Engagement in PTSD Treatment (PEP) - Advancing PTSD Treatment Outcomes
Led by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Updated on 2025-04-09
427
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating ways to improve outpatient treatment for posttraumatic stress disorder (PTSD) among majority ethnic Danes and refugees. This study involves two similar randomized controlled trials at two clinics, aiming to see if adding a motivation enhancement module before PTSD treatment reduces dropout rates and improves outcomes. Another focus is whether an added shared decision-making session, allowing individualized treatment choices, leads to better results compared to standard PTSD treatment or treatment supplemented by motivation enhancement. The study also examines cognitive differences between Danish civilians and refugees with PTSD, motivation's relationship with mental health and quality of life, and perspectives of patients and clinicians on the interventions. Participants receive one of several treatment options depending on the clinic and trial arm. One group receives treatment as usual (TAU) lasting 8-12 months. Another group receives an introductory PTSD module consisting of four sessions focusing on motivation before continuing with TAU for 9-13 months. A third group, only at the refugee clinic, receives the motivational module plus a shared decision-making session to choose one of four standardized treatments, continuing for 9-13 months. The study includes initial assessments, followed by randomization into treatment arms, with sessions led by psychologists, medical doctors, nurses, or social counsellors. During the study, participants complete various self-ratings and observer-rated assessments at baseline, during treatment, at treatment end around 10 months, and at six-month follow-up. Assessments include PTSD symptoms, depression, functioning, motivation, and quality of life using standardized questionnaires and interviews. Patient attendance, session content, medication changes, and treatment adherence are closely monitored. Data collection and analysis are performed with measures to ensure quality, inter-rater reliability, and patient data protection under GDPR. Overall, the trial seeks to understand how motivational readiness and shared decision-making impact PTSD treatment outcomes and engagement.
CONDITIONS
Brief Title
Patient Engagement in PTSD Treatment (PEP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of PTSD according to ICD-10 research criteria
- Signed informed consent to participate
- Referred for "Main Level" PTSD treatment (Psychotherapeutic Unit)
- Refugees or persons family reunified with a refugee (Competence Centre of Transcultural Psychiatry)
- Psychological trauma experienced outside Denmark such as imprisonment with torture, organized violence, political persecution, or war experiences (Competence Centre of Transcultural Psychiatry)
You will not qualify if you...
- Severe psychotic disorder unrelated to PTSD or depression (ICD-10 diagnosis F2x and F30.1-F31.9)
- Active dependence syndrome of drugs or alcohol (F1x.24-F1x.26)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 4 assessment sessions totaling approximately 2 to 3 hours
Duration - Approximately 1.5 months
Participants in the intervention groups receive four sessions focused on motivation to prepare for PTSD treatment.
4 sessions
Duration - Single session during treatment
Participants in one intervention group attend a patient-centered shared decision making session to choose one of four standardized treatments.
1 session
Duration - 8 to 13 months
Participants receive outpatient PTSD treatment which may include sessions with psychologists, nurses, or medical doctors, lasting 8 to 13 months depending on the group assignment.
Regular treatment sessions as scheduled by the clinic
Duration - Follow-up at 6 months post-treatment
Participants complete assessments to evaluate PTSD symptoms and treatment outcomes approximately six months after treatment ends.
1 follow-up assessment visit
Trial Site Locations
Total: 1 location
1
Mental Health Centre Ballerup
Ballerup Municipality, Capital Region, Denmark, 2750
Actively Recruiting
Research Team
A
Anna Bolette L. Nielsen, Medical Doctor
L
Laura E. Fonnesbaek, Authorised psychologist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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