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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Observation
fMRI
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Prolonged Exposure Therapy

    30 Danish veterans without PTSD

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    July 2, 2015
    Last Updated
    August 9, 2016
    Sponsor
    Aalborg University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02519296
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    January 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aalborg University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Disorders, Post-Traumatic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prolonged Exposure Therapy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    30 Danish veterans without PTSD
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Prolonged Exposure Therapy
    Intervention Description
    8 sessions with prolonged exposure therapy and fMRI.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Observation
    Intervention Description
    fMRI.
    Intervention Type
    Device
    Intervention Name(s)
    fMRI
    Intervention Description
    Functional Magnetic Resonance Imaging of the brain
    Primary Outcome Measure Information:
    Title
    Psychometric changes
    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.
    Time Frame
    Baseline - 3-6-12-36 months
    Secondary Outcome Measure Information:
    Title
    Biomedical changes
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Morten Kjølbye, MD
    Organizational Affiliation
    Aalborg University Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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