A fMRI Study of the Treatment of Danish Veterans With PTSD With Prolonged Exposure Therapy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A fMRI Study of the Treatment of Danish Veterans With Post-Traumatic Stress Disorder With Prolonged Exposure Therapy: Study Protocol for a Case-control Trial

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Prolonged Exposure Therapy
* Behavioral: Observation
* Device: fMRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases: Danish veterans with ICD-10 diagnostic criteria for PTSD Controls: Danish veterans without ICD-10 diagnostic criteria for PTSD 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: F20 to F29 Schizophrenia Schizotypical mental disorder Delusional disorder Acute and transient psychotic disorders and Schizoaffective psychosis F30 Manic single episode F31 Bipolar affective disorder F60.2 Dyssocial personality structure F60.3 Emotionally unstable personality structure F90 Hyperkinetic disorder (ADHD) F98.8 Other behavioural and emotional disorders in childhood and adolescence (ADD) 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: Ferromagnetic prostheses (including straps prostheses, clips on blood vessels, pacemakers, and metal splinters) claustrophobia and movements during the scan.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prolonged Exposure Therapy<br>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. | Behavioral: Prolonged Exposure Therapy<br>* 8 sessions with prolonged exposure therapy and fMRI.<br>Behavioral: Observation<br>* fMRI.<br>Device: fMRI<br>* Functional Magnetic Resonance Imaging of the brain<br>|
| Active Comparator: 30 Danish veterans without PTSD<br>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. | Behavioral: Observation<br>* fMRI.<br>Device: fMRI<br>* Functional Magnetic Resonance Imaging of the brain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |