NCT05342480

Brief Summary

Aim of the study: Post traumatic stress disorder (PTSD) is a psychiatric illness that can develop after having experienced traumatic, often life treathening, events. The symptoms often leads to significant subjective suffering, and may limit vocational and social functioning. Intensive trauma treatment with Eye Movement Desensitization and Reprocessing (EMDR) and Prolonged Exposure (PE) of patients with PTSD has not previously been conducted in an inpatient setting in Norway. In this study we foremost seek to examine if this combined intervention, given at a five day inpatient unit, is suitable to a norwegian PTSD population and clinical setting. We will do this by systematically gathering information about how many drop out of the treatment program, and if so, at what stage of the program. We will also ask the patients to complete a short questionnaire about how they viewed the treatment program overall, and the separate parts of the program. We also wish to examine how the patients experienced the intervention, and in what way it contributet to their possible improvemen,t through a qualitative interview. We will also use well established clinical self report questionnaires to investigate if the patients who participate in the treatment program will experience an improvement of their PTSD symptoms and improved functioning, and examine if this possible improvement lasts two and six months post treament. Method: This is a pilotstudy where a total of twelve patients with PTSD will be recruited from the Nydalen outpatient department, Oslo University Hospital. The patients have to satisfy the studies inclusion criteria, including having experienced at least two traumatic experiences, and had at least one previous psyhotherapeutic treament. The patients will be examined with validated self report questionnaires before and after the intervention, as well as after two and six months post treatment. Six patients will be invited to participate in a qualitative interview focusing on their experience of the intervention. The Intervention: Treatment program monday to friday with daily PE and EMDR sessions, physical activity between sessions, in vivo exposure treament and psychoeducational groups. Daily rotation of both EMDR and PE therapists. Multidisiplinary team attached to each patient. Significance of the study: Intensive inpatient trauma treatment with EMDR and PE have not previously been done in Norway. It has neither, as far as we know, been conducted any qualitative studies of this intensive combined treatment method internationally.The project wish to contribute to change trauma treatment in our hospital from a stabilisation focus to a focus on active trauma processing and treatment, to increase our staffs and therapists competency in trauma treatment, and to further the national and international body of knowledge about how patients with PTSD best can experience functional and symptomatic improvement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

April 17, 2022

Last Update Submit

March 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • PTSD symptom reduction

    Change on Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) questionnaire. Max score 80, minimum score 0. 0= no PTSD symptoms

    2 weeks, 2 months, 6 months

Interventions

Daily program monday to friday with daily PE and EMDR sessions, physical activity between sessions, in vivo exposure treament and psychoeducational groups. Daily rotation of both EMDR and PE therapists. Multidisiplinary team attached to each pati

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Satisfying diagnostic criteria for PTSD (based on the MINI diagnostic interview)
  • having experienced at least two traumatic experiences
  • had at least one previous psyhotherapeutic treament (\> 3 months)
  • ability to speak a scandinacian language,

You may not qualify if:

  • IQ \<70, substance abuse
  • regular use of benzodiazapines
  • serious suicidality (suicide attempt last 3 months)
  • neurological illness or significant headinjury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0351, Norway

Location

Related Publications (3)

  • Vaage-Kowalzik V, Engeset J, Jakobsen M, Evensen JH. "The world does not look the same anymore": The experiences of patients six months after finishing an intensive trauma treatment program. BMC Psychol. 2025 Dec 12. doi: 10.1186/s40359-025-03826-2. Online ahead of print.

  • Vaage-Kowalzik V, Engeset J, Jakobsen M, Evensen JH. Educational, but demanding: the experience of therapists in an intensive inpatient trauma treatment program. Front Psychol. 2025 Aug 29;16:1581055. doi: 10.3389/fpsyg.2025.1581055. eCollection 2025.

  • Vaage-Kowalzik V, Engeset J, Jakobsen M, Andreassen W, Evensen JH. Exhausting, but necessary: the lived experience of participants in an intensive inpatient trauma treatment program. Front Psychol. 2024 May 28;15:1341716. doi: 10.3389/fpsyg.2024.1341716. eCollection 2024.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Julie Evensen, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot study PTSD trauma treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Research coordinator

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 22, 2022

Study Start

April 8, 2022

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations