Menu
Recruiting NCT07565311

Two-week Intensive Outpatient Trauma Treatment.

No phase Interventional Posttraumatic Stress Disorder (PTSD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prolonged exposure and EMDR.
Who it may be relevant to
Registry conditions: Posttraumatic Stress Disorder (PTSD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Other Prolonged exposure and EMDR
    Two-week intensive traume treatment

Primary outcome measures

  • Trauma symptom score as measured by International Trauma Questionnaire (ITQ) [Time frame: 12 weeks]
Secondary outcome measures (1)
  • Function as measured by Work and social adjustment scale (WSAS) [Time frame: 12 weeeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Norway · 1 center
  • Oslo University Hospital — Oslo

Identifiers

NCT: NCT07565311 · 260225

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗