Support for trauma exposure victims
Early Support After Exposure to Trauma
This study tests a new online therapy for people dealing with post-traumatic stress symptoms after a traumatic event to see if it helps them feel better and is cost-effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 16 Years to 99 Years |
| Sex | All |
| Sponsor | Norwegian Center for Violence and Traumatic Stress Studies Academic / other |
| Locations | 29 sites (Asker, Asker and 28 other locations) |
| Trial ID | NCT06592677 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and cost-effectiveness of a condensed internet-delivered prolonged exposure therapy (CIPE) for individuals experiencing post-traumatic stress symptoms (PTSS) after a traumatic event. Participants will receive CIPE approximately one month after trauma, alongside treatment-as-usual (TAU) from municipal crisis teams. The intervention is designed to be therapist-assisted and is based on established principles of prolonged exposure therapy. The study aims to fill the gap in evidence-based preventive interventions available for trauma victims in Norway.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and above who have experienced a traumatic event within the last month and are receiving support from a municipal crisis team.
Not a fit: Patients with severe psychopathology requiring specialized care or ongoing trauma may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of PTSD among trauma victims by providing timely and effective support.
How similar studies have performed: Previous studies have shown that internet-delivered prolonged exposure therapy is feasible and effective, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Receives support from a municipal crisis team * Exposure to a traumatic event (as defined by criteria A for the diagnosis of post-traumatic stress disorder (PTSD) in the DSM-5) within the last seven weeks before randomization * A total score of 10 or above on the PTSD Symptom Checklist-5 at the time of randomization * Age 16 or above * Written informed consent * Writes and speaks English and/or Norwegian Exclusion Criteria: * Severe psychopathology in need of specialized health care (e.g., psychotic symptoms, or high suicide risk) or substance dependence syndrome in need of specialized health care * Known or evident severe cognitive impairment * Ongoing traumatization, violence, or threats * Unstable dose of psychotropic medication two weeks prior to randomization * Concurrent therapy elsewhere before randomization
Where this trial is running
Asker, Asker and 28 other locations
- Asker municipality - Psychosocial crisis team — Asker, Asker, Norway (Recruiting)
- Psychosocial crisis team - Indre Østfold kommune — Askim, Askim, Norway (Recruiting)
- Psychosocial crisis team - Oslo, St Hanshaugen — Oslo, Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Ullern — Oslo, Oslo, Norway (Recruiting)
- Norwegian Center for Violence and Traumatic Stress Studies — Oslo, Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Nordre Aker — Oslo, Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Østensjø — Oslo, Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Vestre Aker — Oslo, Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Grorud — Oslo, Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Alna — Oslo, Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Søndre Nordstrand — Oslo, Oslo, Norway (Recruiting)
- Aurskog-Høland - Psychosocial crisis team — Bjørkelangen, Norway (Recruiting)
- Fredrikstad municipality - Psychosocial Crisis team — Fredrikstad, Norway (Recruiting)
- Gjøvik municipality - psychosocial crisis team — Gjøvik, Norway (Recruiting)
- Halden Municipality - psychosocial crisis team — Halden, Norway (Recruiting)
- Hamar Municipality - psychosocial crisis team — Hamar, Norway (Recruiting)
- Søndre Land municipality - psychosocial crisis team — Hov, Norway (Recruiting)
- Ullensaker municipality - psychosocial crisis team — Jessheim, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Bjerke — Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Frogner — Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, gamle Oslo — Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Grünerløkka — Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Nordstrand — Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Sagene — Oslo, Norway (Recruiting)
- Psychosocial crisis team - Oslo, Stovner — Oslo, Norway (Recruiting)
- Psychosocial emergency service - Oslo emergency room — Oslo, Norway (Recruiting)
- Ringsaker municipality - Psychosocial crisis team — Ringsaker, Norway (Recruiting)
- Gjerdrum - psychosocial crisis team — Sørum, Norway (Recruiting)
- Nannestad municipality - psychosocial crisis team — Teigebyen, Norway (Recruiting)
Study contacts
- Principal investigator: Harald Bækkelund, PhD — Norwegian Center for Violence and Traumatic Stress Studies
- Study coordinator: Harald Bækkelund, PhD
- Email: harald.bakkelund@nkvts.no
- Phone: +47 90964268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.