NCT02519296

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

4 years

First QC Date

July 2, 2015

Last Update Submit

August 9, 2016

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline - 3-6-12-36 months

Secondary Outcomes (1)

  • Biomedical changes

    Baseline - end of treatment - 36 months

Study Arms (2)

Prolonged Exposure Therapy

ACTIVE COMPARATOR

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 TherapyBehavioral: ObservationDevice: fMRI

30 Danish veterans without PTSD

ACTIVE COMPARATOR

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: ObservationDevice: fMRI

Interventions

Prolonged Exposure TherapyBEHAVIORAL

8 sessions with prolonged exposure therapy and fMRI.

Prolonged Exposure Therapy
ObservationBEHAVIORAL

fMRI.

30 Danish veterans without PTSDProlonged Exposure Therapy
fMRIDEVICE

Functional Magnetic Resonance Imaging of the brain

30 Danish veterans without PTSDProlonged Exposure Therapy

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cases: Danish veterans with ICD-10 diagnostic criteria for PTSD
  • Controls: Danish veterans without ICD-10 diagnostic criteria for PTSD

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

ObservationMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Morten Kjølbye, MD

    Aalborg University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, professor, senior consultant, DrMedSc

Study Record Dates

First Submitted

July 2, 2015

First Posted

August 10, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

August 10, 2016

Record last verified: 2016-08