Post Traumatic Stress DisorderITBDNCT05342480
Intensiv Inpatient Trauma Treatment. A Pilotstudy.
A study testing EMDR and PE combined treatment in people with Post Traumatic Stress Disorder, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- EMDR and PE combined treatment
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- 8 Apr 2022to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- IQ <70, substance abuse
- regular use of benzodiazapines
- serious suicidality (suicide attempt last 3 months)
- neurological illness or significant headinjury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Two Week Inpatient Trauma Treatment. A Pilotstudy.
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.
Read more
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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- EMDR and PE combined treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR and PE combined treatmentOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks, 2 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start8 Apr 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study PTSD trauma treatment
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Horgen Evensen, Oslo University Hospital
- Investigators
- Julie Evensen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342480
- Sponsor's protocol ID
- 453358
- Acronym
- ITBD
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2022
- Last updated
- 21 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evensen JH, Engeset J, Jakobsen M, Malkomsen A, Vaage-Kowalzik V. Intensive trauma-focused treatment for PTSD and Complex PTSD in a public clinic: a feasibility study. Front Psychol. 2026 Sep 9;17:1869412. doi: 10.3389/fpsyg.2026.1869412. eCollection 2026.
PubMed 42780364Vaage-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;14(1):77. doi: 10.1186/s40359-025-03826-2.
PubMed 41382171Vaage-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.
PubMed 40949339Vaage-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.
PubMed 38863672
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Two Week Inpatient Trauma Treatment. A Pilotstudy.
- ClinicalTrials.gov ID
- NCT05342480
- Acronym / sponsor ID
- ITBD / 453358
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Pilot study PTSD trauma treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (4 listed)
- IQ <70, substance abuse
- regular use of benzodiazapines
- serious suicidality (suicide attempt last 3 months)
- neurological illness or significant headinjury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDR and PE combined treatmentDaily 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 | Other | – |
Primary outcome
PTSD symptom reduction
Time frame: 2 weeks, 2 months, 6 months
Change on Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) questionnaire. Max score 80, minimum score 0. 0= no PTSD symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 42780364Evensen JH, Engeset J, Jakobsen M, Malkomsen A, Vaage-Kowalzik V. Intensive trauma-focused treatment for PTSD and Complex PTSD in a public clinic: a feasibility study. Front Psychol. 2026 Sep 9;17:1869412. doi: 10.3389/fpsyg.2026.1869412. eCollection 2026.
- Derived from this study: PubMed 41382171Vaage-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;14(1):77. doi: 10.1186/s40359-025-03826-2.
- Derived from this study: PubMed 40949339Vaage-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.
- Derived from this study: PubMed 38863672Vaage-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Evensen, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR and PE combined treatment in people with Post Traumatic Stress Disorder, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom reduction (time frame: 2 weeks, 2 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342480, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.