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

Not Applicable

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Behavioral: Prolonged Exposure Therapy; Behavioral: Observation; Device: fMRI

• Registration Number: NCT02519296
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-10
• Study Start: 2016-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10
• Primary Completion: 2020-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged Exposure Therapy	Observation	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.
30 Danish veterans without PTSD	Observation	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.
Prolonged Exposure Therapy	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.
Prolonged Exposure Therapy	fMRI	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.
30 Danish veterans without PTSD	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.

Primary Outcome Measures

Name	Time	Method
Psychometric changes	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

Name	Time	Method
Biomedical changes	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.