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

August 9, 2016 updated by: Jørgen Aagaard, Aalborg University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prolonged Exposure Therapy

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
8 sessions with prolonged exposure therapy and fMRI.
Behavioral: Observation
fMRI.
Device: fMRI
Functional Magnetic Resonance Imaging of the brain
Active Comparator: 30 Danish veterans without PTSD

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
fMRI.
Device: fMRI
Functional Magnetic Resonance Imaging of the brain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometric changes
Time Frame: Baseline - 3-6-12-36 months
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
Time Frame: Baseline - end of treatment - 36 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Investigators

  • Study Chair: Morten Kjølbye, MD, Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PE-PTSD-Klinik Syd

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Disorders, Post-Traumatic

Clinical Trials on Prolonged Exposure Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe