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

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ClinicalTrials.gov Identifier: NCT02519296
Recruitment Status : Active, not recruiting
First Posted : August 10, 2015
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Jørgen Aagaard, Aalborg University Hospital

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

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Prolonged Exposure Therapy Behavioral: Observation Device: fMRI Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519296


Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Study Chair: Morten Kjølbye, MD Aalborg University Hospital

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Responsible Party: Jørgen Aagaard, MD, professor, senior consultant, DrMedSc, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT02519296     History of Changes
Other Study ID Numbers: PE-PTSD-Klinik Syd
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders