Perception of Stressful Social Stimuli After Trauma Exposure.

Sponsor

University Hospital, Bonn (Other)

Overall Status

Completed

CT.gov ID

NCT03421587

Collaborator

(none)

100

Enrollment

Location

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Stress Disorder	Behavioral: Processing of social olfactory and tactile stimuli

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Abnormal Processing of Stressful Social Stimuli After Trauma Exposure, in Particular After Childhood Maltreatment.

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Individuals exposed to an intentional/non-intentional trauma	Behavioral: Processing of social olfactory and tactile stimuli Processing of social olfactory and tactile stimuli in trauma-exposed individuals and controls is examined using functional magnetic resonance imaging.
Healthy controls without trauma-exposure	Behavioral: Processing of social olfactory and tactile stimuli Processing of social olfactory and tactile stimuli in trauma-exposed individuals and controls is examined using functional magnetic resonance imaging.

Arm

Intervention/Treatment

Individuals exposed to an intentional/non-intentional trauma

Behavioral: Processing of social olfactory and tactile stimuli

Processing of social olfactory and tactile stimuli in trauma-exposed individuals and controls is examined using functional magnetic resonance imaging.

Healthy controls without trauma-exposure

Behavioral: Processing of social olfactory and tactile stimuli

Processing of social olfactory and tactile stimuli in trauma-exposed individuals and controls is examined using functional magnetic resonance imaging.

Outcome Measures

Primary Outcome Measures

Emotion recognition ratings obtained during a forced-choice emotional face recognition task with stimuli of varying intensities (neutral to fearful). [Ratings will be assessed throughout fMRI scanning over the course of 25 minutes.]
Neural substrates of social tactile stimuli processing. [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. [Ratings will be assessed throughout fMRI scanning over the course of 20 minutes.]
Neural substrates of social olfactory stimuli processing. [The neural substrates will be assessed througout fMRI scanning over the course of 25 minutes.]

Secondary Outcome Measures

Oxytocin plasma concentrations. [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. [The olfactory threshold of all participants will be assessed in a screening session at least 24 hours prior to fMRI scanning.]
Participants' olfactory performance will be assessed by administering the 'Sniffin' Sticks' test, which measures nasal chemosensory performance based on pen-like odor dispensing devices.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Signed informed consent
Subjects that have experienced a traumatic event that meets the DSM-5 criteria

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry, University of Bonn	Bonn		Germany	53105

Sponsors and Collaborators

University Hospital, Bonn

Investigators

Principal Investigator: René Hurlemann, PhD, MD, MSc, Department of Psychiatry, University of Bonn, Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Rene Hurlemann, Vice Chair of the Department of Psychiatry and Chair of the Medical Psychology Division, University Hospital, Bonn

ClinicalTrials.gov Identifier:

NCT03421587

Other Study ID Numbers:

TT-Study

First Posted:

Feb 5, 2018

Last Update Posted:

Feb 15, 2019

Last Verified:

Feb 1, 2019

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Feb 15, 2019