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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05342480
Other study ID # 453358
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 8, 2022
Est. completion date July 1, 2023

Study information

Verified date April 2022
Source Oslo University Hospital
Contact Julie Evensen, PhD
Phone 004799339292
Email uxevej@ous-hf.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date July 1, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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. -

Study Design


Intervention

Other:
EMDR and PE combined treatment
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

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary PTSD symptom reduction Reduction on PCL-5 questionnaire 2 weeks, 2 months, 6 months
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