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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02519296

Enrollment

Registered

2015-08-10

Start date

2016-01-31

Completion date

2021-01-31

Last updated

2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic

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.

Interventions

BEHAVIORALProlonged Exposure Therapy

8 sessions with prolonged exposure therapy and fMRI.

BEHAVIORALObservation

fMRI.

DEVICEfMRI

Functional Magnetic Resonance Imaging of the brain

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 35 Years

Healthy volunteers

Yes

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. *

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026