- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03382808
Emotion Recognition Training in Antisocial Violent Offenders With Psychopathic Traits
December 18, 2017 updated by: University Hospital Tuebingen
Impaired recognition of affective facial expressions has been conclusively linked to antisocial and psychopathy.
However, little is known about the modifiability of this deficit.
This study aims to investigate whether and under which circumstances the proposed perceptual insensitivity can be addressed with a brief implicit training approach.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael Schönenberg, PhD
- Phone Number: 004970712978355
- Email: michael.schoenenberg@uni-tuebingen.de
Study Contact Backup
- Name: Martin Hautzinger, Prof.
Study Locations
-
-
Baden Würrtemberg
-
Tübingen, Baden Würrtemberg, Germany, 72074
- Recruiting
- University of Tubingen
-
Contact:
- Michael Schönenberg, PhD
- Phone Number: 004970712978355
- Email: michael.schoenenberg@uni-tuebingen.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Confirmed ASPD diagnosis
- PCL-Score available
- arrested for committing violent crimes
Exclusion Criteria:
- Insufficient knowledge of the German language
- Diagnosed with schizophrenia
- Substance abuse
- Neurological disease (e.g. epilepsy)
- Mental retardation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SEE Training
The training sequence comprises four weekly sessions using a modified dote-probe paradigm (fearful vs. neutral expression).
|
Participants are first presented with a fixation cross which indicates the beginning of a trial and is immediately followed by a bilateral presentation of a neutral and a fearful image (face) of the same model identity.
The fearful expression is always replaced by an arrow pointing to the left or the right which remaines active until the participant indicates via button-press which direction the arrow is pointing to.
The model identity, the position of the fearful cue and the arrow probe direction are pseudo-randomized across trials with no more than three identical sequential occurrences on each parameter.
Each session consists of 360 trials in total, with 120 distinct trial types and three repetitions.
Participants are trained with neutral and 75% fearful expressions only in the first session; the intensity of the fearful cue is successively decreased by 15% at every subsequent session.
|
Active Comparator: GAZE Training
The GAZE training sequence comprises four weekly sessions using a modified dote-probe paradigm (averted vs. directed gaze).
|
Participants are first presented with a fixation cross, which indicates the beginning of a trial and is immediately followed by a bilateral presentation of a direct gaze-image (neutral face) and an image of a neutral face (same model identity) displaying deviated gaze.
The averted gaze-face is always replaced by an arrow pointing to the left or the right which remaines active until the participant indicates via button-press which direction the arrow is pointing to.
The model identity, the position of the fearful cue and the arrow probe direction are pseudo-randomized across trials with no more than three identical sequential occurrences on each parameter.
Each session consists of 360 trials in total, with 120 distinct trial types and three repetitions.
Participants are trained with direct and 100% averted gaze images only in the first session; the intensity of the deviated gaze cue is successively decreased by 20% at every subsequent session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Animated morph task
Time Frame: change from pre-treatment to post-treatment after 8 weeks
|
Morphed images are presented, beginning with the neutral face that progresses into one of the six affective expressions.
This procedure creates the impression of an animated clip depicting the development of facial emotive expressions.
Participants are instructed to press a button as soon as they are able to identify the emerging expression.
|
change from pre-treatment to post-treatment after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unconscious processing of affective facial expressions during interocular suppression in a breaking Continuous flash suppression paradigm
Time Frame: pre-treatment, after 8 weeks (post-treatment)
|
Change in processing of unaware/unconsciously perceived emotional stimuli as assessed by number of faces correctly identified
|
pre-treatment, after 8 weeks (post-treatment)
|
Eye-Tracking
Time Frame: pre-treatment, after 8 weeks (post-treatment)
|
Change in recognition and visual processing of emotional faces as indicated by raw scores and group means for dwell time, total dwell time, and time to first AOI (mouth/eye region) hit
|
pre-treatment, after 8 weeks (post-treatment)
|
Ambivalence Task
Time Frame: pre-treatment, after 8 weeks (post-treatment)
|
Change in interpretation of ambiguous emotional faces as indicated by number of hostile judgments
|
pre-treatment, after 8 weeks (post-treatment)
|
Emotional search paradigm
Time Frame: pre-treatment, after 8 weeks (post-treatment)
|
Assessment of implicit perceptual biases for and explicit categorization of facial expression in an emotional search paradigm (change pre- to post-intervention)
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pre-treatment, after 8 weeks (post-treatment)
|
Affective prosody
Time Frame: pre-treatment, after 8 weeks (post-treatment)
|
Change in recognition of non-verbal emotional aspects of language as assessed by number of correct classifications
|
pre-treatment, after 8 weeks (post-treatment)
|
Multifaceted empathy test
Time Frame: pre-treatment, after 8 weeks (post-treatment)
|
Assessment of cognitive and emotional empathy (change pre- to post-intervention)
|
pre-treatment, after 8 weeks (post-treatment)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Schönenberg, PhD, University Hospital Tuebingen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
- Schonenberg M, Christian S, Gausser AK, Mayer SV, Hautzinger M, Jusyte A. Addressing perceptual insensitivity to facial affect in violent offenders: first evidence for the efficacy of a novel implicit training approach. Psychol Med. 2014 Apr;44(5):1043-52. doi: 10.1017/S0033291713001517. Epub 2013 Jul 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
December 12, 2017
First Submitted That Met QC Criteria
December 18, 2017
First Posted (Actual)
December 26, 2017
Study Record Updates
Last Update Posted (Actual)
December 26, 2017
Last Update Submitted That Met QC Criteria
December 18, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCHO 1448/3-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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