- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07565311
Two-week Intensive Outpatient Trauma Treatment.
April 27, 2026 updated by: Julie Horgen Evensen, Oslo University Hospital
The objective of the study is to obtain knowledge about the treatment of patients who are offered intensive trauma treatment at Nydalen DPS (NDPS) and Søndre Oslo DPS (SODPS).
The treatment takes place on an outpatient basis over two weeks.
Up to 42 patients will be recruited.
The efficacy of treatment will be investigated using validated self-report forms, which measure PTSD symptoms (PCL-5 and ITQ) and quality of life/function (WHO-5, and WSAS).
The measurements will be done before the treatment and one and twelve weeks after treatment.In-depth interviews will also be conducted with up to 30 patients to investigate the outcome and any need for adjustments with focus on patients with minority backgrounds, men and patients with limited benefit.
The study uses a mixed methods design, where quantitative measures and information from qualitative interviews are combined to map participants' experience, benefits and feasibility.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective of the study is to obtain knowledge about the treatment of patients who are offered intensive trauma treatment at Nydalen DPS (NDPS) and Søndre Oslo DPS (SODPS).
The treatment takes place on an outpatient basis over two weeks.
Up to 42 patients will be recruited.
The efficacy of treatment will be investigated using validated self-report forms, which measure PTSD symptoms (PCL-5 and ITQ) and quality of life/function (WHO-5, and WSAS).
The measurements will be done before the treatment and one and twelve weeks after treatment.
In-depth interviews will also be conducted with up to 30 patients to investigate the outcome and any need for adjustments with focus on patients with minority backgrounds, males and patients with limited benefit.
The study uses a mixed methods design, where quantitative measures and information from qualitative interviews are combined to map participants' experience, benefits and feasibility.
Study Type
Interventional
Enrollment (Estimated)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julie H Evensen, MD PhD
- Phone Number: 004799339292
- Email: uxevej@ous-hf.no
Study Contact Backup
- Name: Veronica Vaage-Kowalzik, MD
- Email: UXVAAG@ous-hf.no
Study Locations
-
-
-
Oslo, Norway
- Recruiting
- Oslo University Hospital
-
Contact:
- Julie Evensen, MD PhD
- Phone Number: 004799339292
- Email: uxevej@ous-hf.no
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- PTSD
- 18-65 years
- Able to give written informed consent.
Exclusion Criteria:
- Active substance abuse
- psychotic or bipolar disorder
- organic brain disorder
- IQ< 70
- Currently in a life-threating situation.
- Serious suicide risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intensive trauma treatment
|
Two-week intensive traume treatment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trauma symptom score as measured by International Trauma Questionnaire (ITQ)
Time Frame: 12 weeks
|
ITQ: Higher score equals higher symptom load
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Function as measured by Work and social adjustment scale (WSAS)
Time Frame: 12 weeeks
|
Higher scores equals poorer function
|
12 weeeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life as measured by WHO-5, PTSD symptom load as measured by PCL-5
Time Frame: 12 weeks
|
Higher scores on WHO-5 equals better QoL, Higher scores on PCL-5 equal more PTSD symptoms
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julie H Evensen, MD PhD, Oslo University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
February 20, 2026
First Submitted That Met QC Criteria
April 27, 2026
First Posted (Actual)
May 4, 2026
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 260225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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