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

Stress Disorders, Post-Traumatic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02519296
• Other study ID #: PE-PTSD-Klinik Syd
• Status: Active, not recruiting
• Phase: N/A
• First received: July 2, 2015
• Last updated: August 9, 2016
• Start date: January 2016
• Est. completion date: January 2021

Study information

• Verified date: August 2016
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure Therapy
8 sessions with prolonged exposure therapy and fMRI.
• Observation
fMRI.

Device:
• fMRI
Functional Magnetic Resonance Imaging of the brain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No