Stress Disorders, Post-TraumaticNCT02519296
A fMRI Study of the Treatment of Danish Veterans With PTSD With Prolonged Exposure Therapy
A study testing Prolonged Exposure Therapy, Observation and fMRI in people with Stress Disorders, Post-Traumatic, run by Aalborg University Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Prolonged Exposure Therapy, Observation and fMRI
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cases: Danish veterans with ICD-10 diagnostic criteria for PTSD
- Controls: Danish veterans without ICD-10 diagnostic criteria for PTSD
Who cannot join
- 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
Show all 17Show fewer
- 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.
- Ferromagnetic prostheses (including straps prostheses, clips on blood vessels, pacemakers, and metal splinters)
- claustrophobia and movements during the scan.
About this study
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
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
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Prolonged Exposure Therapy, Observation, fMRI
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure TherapyBehavioural
8 sessions with prolonged exposure therapy and fMRI.
ObservationBehavioural
fMRI.
fMRIDevice
Functional Magnetic Resonance Imaging of the brain
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prolonged Exposure Therapy; Behavioral: Observation; Device: 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. Receives: Behavioral: Observation; Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - 3-6-12-36 months
Secondary outcomes (1)
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.
Measured: Baseline - end of treatment - 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jørgen Aagaard, Aalborg University Hospital
- Investigators
- Morten Kjølbye, MD, Study chair, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519296
- Sponsor's protocol ID
- PE-PTSD-Klinik Syd
- Status last verified
- Aug 2016
- First submitted
- 2 Jul 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02519296
- Acronym / sponsor ID
- PE-PTSD-Klinik Syd
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure Therapy | Active comparator | Behavioral: Prolonged Exposure Therapy, Behavioral: Observation, Device: fMRIIn 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 | Active comparator | Behavioral: Observation, Device: fMRIA 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Cases: Danish veterans with ICD-10 diagnostic criteria for PTSD
- Controls: Danish veterans without ICD-10 diagnostic criteria for PTSD
Key exclusion criteria (17 listed)
- 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:
- Participants who have a daily intake of sedative, anxiolytic
- Participants who score below 23 on the Mini Mental State Examination, and (5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure Therapy8 sessions with prolonged exposure therapy and fMRI. | Behavioural | Prolonged Exposure Therapy |
| ObservationfMRI. | Behavioural | 30 Danish veterans without PTSD, Prolonged Exposure Therapy |
| fMRIFunctional Magnetic Resonance Imaging of the brain | Device | 30 Danish veterans without PTSD, Prolonged Exposure Therapy |
Primary outcome
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.
1 secondary outcome
Biomedical changes
Time frame: Baseline - end of treatment - 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Kjølbye, MD study chair
Aalborg University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure Therapy, Observation and fMRI in people with Stress Disorders, Post-Traumatic, run by Aalborg University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric changes (time frame: Baseline - 3-6-12-36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.