Two-week Intensive Outpatient Trauma Treatment. | NCT07565311

Studies
Two-week Intensive Outpatient Trauma Treatment.

NCT07565311

Sponsor

Oslo University Hospital

Status

Recruiting

Last Update Posted

May 4, 2026Actual

Enrollment

42Estimated

Phase

Not Applicable

Conditions

Posttraumatic Stress Disorder (PTSD)

Interventions

Prolonged exposure and EMDR

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2026Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Feb 20, 2026

First Submission Date that Met QC Criteria

Apr 27, 2026

First Posted Date

May 4, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

May 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julie Horgen Evensen, Principal investigator, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intensive trauma treatment	Experimental		Other: Prolonged exposure and EMDR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prolonged exposure and EMDR	Other	Two-week intensive traume treatment	Intensive trauma treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trauma symptom score as measured by International Trauma Questionnaire (ITQ)	ITQ: Higher score equals higher symptom load	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Function as measured by Work and social adjustment scale (WSAS)	Higher scores equals poorer function	12 weeeks

Other Outcomes

Measure	Description	Time Frame
Quality of life as measured by WHO-5, PTSD symptom load as measured by PCL-5	Higher scores on WHO-5 equals better QoL, Higher scores on PCL-5 equal more PTSD symptoms	12 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julie H Evensen, MD PhD	Contact	004799339292		uxevej@ous-hf.no
Veronica Vaage-Kowalzik, MD	Contact			UXVAAG@ous-hf.no

Overall Officials

Name	Affiliation	Role
Julie H Evensen, MD PhD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital	Recruiting	Oslo			Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057169	Eye Movement Desensitization Reprocessing

Ancestor Terms

ID	Term
D003887	Desensitization, Psychologic
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided