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In this article, the investigators report the design and protocol of a functional magnetic resonance imaging study (fMRI) of the treatment of Danish veterans with PTSD with Prolonged Exposure Therapy (PE). In total 30 Danish veterans will be recruited, who meet the ICD-10 diagnostic criteria for PTSD, and treated with PE. A group of controls will be recruited consisting of age-appropriate same sex veterans who have participated in international missions similar to the patient group
Primary outcome measures are the changes in d2-test assessment of attention and concentration, Beck Depression Inventory, Post-traumatic Symptom Scale-Interview version and PTSD Checklist- Military Version.
Secondary outcome measures concern changes of Brain Derived Neurotrophic Factor (BNDF) and changes in the brain structure with focus on the hippocampal function using fMRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Exposure Therapy | Active Comparator | In total 30 Danish veterans will be recruited, who meet the ICD-10 diagnostic criteria for PTSD, and treated with PE. Intervention with eight sessions of PE, psychometrics, blood analyses and fMRI. |
|
| 30 Danish veterans without PTSD | Active Comparator | A group of controls will be recruited consisting of age-appropriate same sex veterans who have participated in international missions similar to the patient group. Observation with psychometrics, blood analyses and fMRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure Therapy | Behavioral | 8 sessions with prolonged exposure therapy and fMRI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychometric changes | Primary outcome measures are the changes in d2-test assessment of attention and concentration, Beck Depression Inventory, Post-traumatic Symptom Scale-Interview version and PTSD Checklist- Military Version. | Baseline - 3-6-12-36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biomedical changes | Secondary outcome measures concern changes of Brain Derived Neurotrophic Factor (BNDF) and changes in the brain structure with focus on the hippocampal function using fMRI. | Baseline - end of treatment - 36 months |
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Inclusion Criteria:
Exclusion Criteria:
Participants who have an active abuse of psychoactive substances with daily consumption.
Participants who consume more than 21 units of alcohol per week, and who, during the last month, have had repetitive episodes with craving, episodes of loss of control due to alcohol consumption, and a weakened ability to manage consumption, stop or reduce consumption
Participants who have a current ICD-10 diagnosis within:
Participants who have a daily intake of sedative, anxiolytic
Participants who score below 23 on the Mini Mental State Examination, and (5)
Participants who within the last 3 months have had a serious suicide attempt.
Exclusion criteria related to the fMRI scanning include:
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| Name | Affiliation | Role |
|---|---|---|
| Morten Kjølbye, MD | Aalborg University Hospital | Study Chair |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
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| Observation | Behavioral | fMRI. |
|
| fMRI | Device | Functional Magnetic Resonance Imaging of the brain |
|
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |