Post-traumatic Stress DisorderNCT03421587
Perception of Stressful Social Stimuli After Trauma Exposure.
An observational study of Post-traumatic Stress Disorder, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Post-traumatic stress disorder is associated with altered processing of sensory stimuli. The clinical phenotype PTSD has predominantly been described for the visual and auditory sensory modalities. However, PTSD symptoms such as intrusive memories are often evoked by olfactory and tactile cues in the environment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Processing of social olfactory and tactile stimuli
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Dec 2018
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of trauma-exposed subjects and healthy controls without trauma-exposure.Patients and healthy controls will be recruited from the Bonn area.
Who may be able to join
- Signed informed consent
- Subjects that have experienced a traumatic event that meets the DSM-5 criteria
Who cannot join
- Schizophrenia, schizoaffective or other psychotic disorder
- Neurological disorders
- Psychotropic medication
- Subjects suffering from a respiratory tract infection or other respiratory disorder known to affect olfactory functioning at investigator's discretion
- Subjects with anosmia or other previous primary olfactory dysfunction (olfactory threshold score using the "Sniffin' Sticks" ≤ 5)
- Dermatitis of the extremities or other skin disorders that affect the skin sensitivity of the extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abnormal Processing of Stressful Social Stimuli After Trauma Exposure, in Particular After Childhood Maltreatment.
Post-traumatic stress disorder is associated with altered processing of sensory stimuli. The clinical phenotype PTSD has predominantly been described for the visual and auditory sensory modalities. However, PTSD symptoms such as intrusive memories are often evoked by olfactory and tactile cues in the environment. Moreover, little is known about whether aberrant responses to social olfactory and tactile stimuli are also present in a subclinical population.The purpose of this study is to compare trauma-exposed subjects (e.g. childhood maltreatment) with non-exposed controls in the processing of olfactory and tactile stimuli. This sensory characterizations hold potential to identify potential biomarkers for the course of trauma-related disorders and to inform trauma therapies focusing on sensory integration.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Processing of social olfactory and tactile stimuli
- 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.
Processing of social olfactory and tactile stimuliBehavioural
Processing of social olfactory and tactile stimuli in trauma-exposed individuals and controls is examined using functional magnetic resonance imaging.
| Study group | Role | What they receive |
|---|---|---|
| Individuals exposed to an intentional/non-intentional trauma | Not described Receives: Behavioral: Processing of social olfactory and tactile stimuli | |
| Healthy controls without trauma-exposure | Not described Receives: Behavioral: Processing of social olfactory and tactile stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion recognition ratings obtained during a forced-choice emotional face recognition task with stimuli of varying intensities (neutral to fearful).
Measured: Ratings will be assessed throughout fMRI scanning over the course of 25 minutes.
Neural substrates of social tactile stimuli processing.
fMRI scanning will be used to measure neural respones to tactile stimuli.
Measured: The neural substrates will be assessed througout fMRI scanning over the course of 20 minutes.
Valence ratings of social tactile stimuli.
Measured: Ratings will be assessed throughout fMRI scanning over the course of 20 minutes.
Neural substrates of social olfactory stimuli processing.
Measured: The neural substrates will be assessed througout fMRI scanning over the course of 25 minutes.
Secondary outcomes (2)
Oxytocin plasma concentrations.
Measured: The oxytocin plasma concentrations of all participants will be assessed 15 minutes before fMRI scanning onset..
Olfactory performance in a n-butanol odor staircase threshold test.
Participants' olfactory performance will be assessed by administering the 'Sniffin' Sticks' test, which measures nasal chemosensory performance based on pen-like odor dispensing devices.
Measured: The olfactory threshold of all participants will be assessed in a screening session at least 24 hours prior to fMRI scanning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startNov 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene Hurlemann, University Hospital, Bonn
- Investigators
- René Hurlemann, PhD, MD, MSc, Principal investigator, Department of Psychiatry, University of Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421587
- Sponsor's protocol ID
- TT-Study
- Status last verified
- Feb 2019
- First submitted
- 12 Aug 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormal Processing of Stressful Social Stimuli After Trauma Exposure, in Particular After Childhood Maltreatment.
- ClinicalTrials.gov ID
- NCT03421587
- Acronym / sponsor ID
- TT-Study
- Conditions
- Post-traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- 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.
Post-traumatic stress disorder is associated with altered processing of sensory stimuli. The clinical phenotype PTSD has predominantly been described for the visual and auditory sensory modalities. However, PTSD symptoms such as intrusive memories are often evoked by olfactory and tactile cues in the environment. Moreover, little is known about whether aberrant responses to social olfactory and tactile stimuli are also present in a subclinical population.The purpose of this study is to compare trauma-exposed subjects (e.g. childhood maltreatment) with non-exposed controls in the processing of olfactory and tactile stimuli. This sensory characterizations hold potential to identify potential biomarkers for the course of trauma-related disorders and to inform trauma therapies focusing on sensory integration.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals exposed to an intentional/non-intentional trauma | – | Behavioral: Processing of social olfactory and tactile stimuli |
| Healthy controls without trauma-exposure | – | Behavioral: Processing of social olfactory and tactile stimuli |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of trauma-exposed subjects and healthy controls without trauma-exposure.Patients and healthy controls will be recruited from the Bonn area.
Key inclusion criteria (2 listed)
- Signed informed consent
- Subjects that have experienced a traumatic event that meets the DSM-5 criteria
Key exclusion criteria (6 listed)
- Schizophrenia, schizoaffective or other psychotic disorder
- Neurological disorders
- Psychotropic medication
- Subjects suffering from a respiratory tract infection or other respiratory disorder known to affect olfactory functioning at investigator's discretion
- Subjects with anosmia or other previous primary olfactory dysfunction (olfactory threshold score using the "Sniffin' Sticks" ≤ 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 |
|---|---|---|
| Processing of social olfactory and tactile stimuliProcessing of social olfactory and tactile stimuli in trauma-exposed individuals and controls is examined using functional magnetic resonance imaging. | Behavioural | Healthy controls without trauma-exposure, Individuals exposed to an intentional/non-intentional trauma |
Primary outcome
Emotion recognition ratings obtained during a forced-choice emotional face recognition task with stimuli of varying intensities (neutral to fearful).
Time frame: Ratings will be assessed throughout fMRI scanning over the course of 25 minutes.
Neural substrates of social tactile stimuli processing.
Time frame: The neural substrates will be assessed througout fMRI scanning over the course of 20 minutes.
fMRI scanning will be used to measure neural respones to tactile stimuli.
Valence ratings of social tactile stimuli.
Time frame: Ratings will be assessed throughout fMRI scanning over the course of 20 minutes.
Neural substrates of social olfactory stimuli processing.
Time frame: The neural substrates will be assessed througout fMRI scanning over the course of 25 minutes.
2 secondary outcomes
Oxytocin plasma concentrations.
Time frame: The oxytocin plasma concentrations of all participants will be assessed 15 minutes before fMRI scanning onset..
Olfactory performance in a n-butanol odor staircase threshold test.
Time frame: The olfactory threshold of all participants will be assessed in a screening session at least 24 hours prior to fMRI scanning.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Related InfoLink provided by the sponsor.
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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.
René Hurlemann, PhD, MD, MSc principal investigator
Department of Psychiatry, University of Bonn, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-traumatic Stress Disorder, run by University Hospital, Bonn at 1 site in Germany.
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 6 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: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emotion recognition ratings obtained during a forced-choice emotional face recognition task with stimuli of varying intensities (neutral to fearful). (time frame: Ratings will be assessed throughout fMRI scanning over the course of 25 minutes.). The study lists 4 primary outcomes in all. 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 15 Feb 2019.