Clinical trial NCT05342480: Intensiv Inpatient Trauma Treatment. A Pilotstudy.
Official title: Intensive Two Week Inpatient Trauma Treatment. A Pilotstudy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study PTSD trauma treatment
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

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

Primary outcomes:
measure: PTSD symptom reduction
timeFrame: 2 weeks, 2 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Julie Evensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: