Clinical trial NCT02519296: A fMRI Study of the Treatment of Danish Veterans With PTSD With Prolonged Exposure Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Psychometric changes
timeFrame: Baseline - 3-6-12-36 months
Secondary outcomes:
measure: Biomedical changes
timeFrame: Baseline - end of treatment - 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Aalborg University Hospital
name: Morten Kjølbye, MD
role: STUDY_CHAIR
References: