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

N/AUnknownNCT02519296

Aalborg University Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress Disorders, Post-Traumatic

Interventions

Prolonged Exposure TherapyBEHAVIORAL

8 sessions with prolonged exposure therapy and fMRI.

ObservationBEHAVIORAL

fMRI.

fMRIDEVICE

Functional Magnetic Resonance Imaging of the brain

Eligibility

Sex: ALLMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Psychometric changes

Time frame: Baseline - 3-6-12-36 months

Secondary Outcomes

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.

Time frame: Baseline - end of treatment - 36 months

Data from ClinicalTrials.gov

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