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Intensiv Inpatient Trauma Treatment. A Pilotstudy. (ITBD)

Primary Purpose

Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
EMDR and PE combined treatment
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Sites / Locations

  • Oslo University HospitalRecruiting

Outcomes

Primary Outcome Measures

PTSD symptom reduction
Reduction on PCL-5 questionnaire

Secondary Outcome Measures

Full Information

First Posted
April 17, 2022
Last Updated
April 17, 2022
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05342480
Brief Title
Intensiv Inpatient Trauma Treatment. A Pilotstudy.
Acronym
ITBD
Official Title
Intensive Two Week Inpatient Trauma Treatment. A Pilotstudy.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study PTSD trauma treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
EMDR and PE combined treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
PTSD symptom reduction
Description
Reduction on PCL-5 questionnaire
Time Frame
2 weeks, 2 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Evensen, PhD
Phone
004799339292
Email
uxevej@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Wenche Andreassen, Master
Phone
004791860956
Email
uxandw@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Evensen, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0351
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Evensen, PhD
Phone
004799339292
Email
uxevej@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Wenche Andreassen, Master
Email
uxandw@ous-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intensiv Inpatient Trauma Treatment. A Pilotstudy.

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