PsychopathyNCT03382808
Emotion Recognition Training in Antisocial Violent Offenders With Psychopathic Traits
A study testing SEE Training and GAZE Training in people with Psychopathy and Violent Aggressive Behavior, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Impaired recognition of affective facial expressions has been conclusively linked to antisocial and psychopathy. However, little is known about the modifiability of this deficit. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Psychopathy, Violent Aggressive Behavior, Emotional Problem
- What is being tested?
- SEE Training and GAZE Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 31 Dec 2019
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed ASPD diagnosis
- PCL-Score available
- arrested for committing violent crimes
Who cannot join
- Insufficient knowledge of the German language
- Diagnosed with schizophrenia
- Substance abuse
- Neurological disease (e.g. epilepsy)
- Mental retardation
Trial locations and contacts
1 site in 1 country.
Martin Hautzinger, Prof. contact
Germany1 site, 1 recruiting
- Recruiting
University of Tübingen
Tübingen, Baden Würrtemberg, 72074
Michael Schönenberg, PhD, 004970712978355, michael.schoenenberg@uni-tuebingen.de
About this study
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.
- Conditions
- Psychopathy, Violent Aggressive Behavior, Emotional Problem
- Being tested
- SEE Training, GAZE Training
- Medical subject headings
- Antisocial Personality Disorder, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEE TrainingBehavioural
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.
GAZE TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SEE Training | Experimental | The training sequence comprises four weekly sessions using a modified dote-probe paradigm (fearful vs. neutral expression). Receives: Behavioral: SEE Training |
| GAZE Training | Active comparator | The GAZE training sequence comprises four weekly sessions using a modified dote-probe paradigm (averted vs. directed gaze). Receives: Behavioral: GAZE Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Animated morph task
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.
Measured: change from pre-treatment to post-treatment after 8 weeks
Secondary outcomes (6)
Unconscious processing of affective facial expressions during interocular suppression in a breaking Continuous flash suppression paradigm
Change in processing of unaware/unconsciously perceived emotional stimuli as assessed by number of faces correctly identified
Measured: pre-treatment, after 8 weeks (post-treatment)
Eye-Tracking
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
Measured: pre-treatment, after 8 weeks (post-treatment)
Ambivalence Task
Change in interpretation of ambiguous emotional faces as indicated by number of hostile judgments
Measured: pre-treatment, after 8 weeks (post-treatment)
Emotional search paradigm
Assessment of implicit perceptual biases for and explicit categorization of facial expression in an emotional search paradigm (change pre- to post-intervention)
Measured: pre-treatment, after 8 weeks (post-treatment)
Affective prosody
Change in recognition of non-verbal emotional aspects of language as assessed by number of correct classifications
Measured: pre-treatment, after 8 weeks (post-treatment)
Multifaceted empathy test
Assessment of cognitive and emotional empathy (change pre- to post-intervention)
Measured: pre-treatment, after 8 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Apr 2017
- Primary completion1 Mar 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychopathyStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Michael Schönenberg, PhD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382808
- Sponsor's protocol ID
- SCHO 1448/3-1
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23809680Gibbon 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.
PubMed 32880104
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Recognition Training in Antisocial Violent Offenders With Psychopathic Traits
- ClinicalTrials.gov ID
- NCT03382808
- Acronym / sponsor ID
- SCHO 1448/3-1
- Conditions
- Psychopathy, Violent Aggressive Behavior, Emotional Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Dec 2017 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEE Training | Experimental | Behavioral: SEE TrainingThe training sequence comprises four weekly sessions using a modified dote-probe paradigm (fearful vs. neutral expression). |
| GAZE Training | Active comparator | Behavioral: GAZE TrainingThe GAZE training sequence comprises four weekly sessions using a modified dote-probe paradigm (averted vs. directed gaze). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed ASPD diagnosis
- PCL-Score available
- arrested for committing violent crimes
Key exclusion criteria (5 listed)
- Insufficient knowledge of the German language
- Diagnosed with schizophrenia
- Substance abuse
- Neurological disease (e.g. epilepsy)
- Mental retardation
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 |
|---|---|---|
| SEE TrainingParticipants 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. | Behavioural | SEE Training |
| GAZE TrainingParticipants 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. | Behavioural | GAZE Training |
Primary outcome
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.
6 secondary outcomes
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)
Eye-Tracking
Time frame: pre-treatment, after 8 weeks (post-treatment)
Ambivalence Task
Time frame: pre-treatment, after 8 weeks (post-treatment)
Emotional search paradigm
Time frame: pre-treatment, after 8 weeks (post-treatment)
Affective prosody
Time frame: pre-treatment, after 8 weeks (post-treatment)
Multifaceted empathy test
Time frame: pre-treatment, after 8 weeks (post-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Background: PubMed 23809680Schonenberg 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.
- Derived from this study: PubMed 32880104Gibbon 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.
- Individual participant dataSharing planned: No
Related trials for Psychopathy
Recruiting
Effects of Transcranial Magnetic Stimulation on Social Cognition, Cognitive Processing, and Functional Brain Architecture
Psychopathy
Recruiting
Virtual Reality (VR-GINSO) as an Complement to Intervention for Alcohol and Cannabis Use in Youth in Residential Care
Dual Diagnosis, Risk Youth
Recruiting
PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy
Antisocial Personality Disorder (ASPD)
Recruiting
Listening Effort in Cochlear Implant Users
Auditory Perception; Abnormal, Hearing Loss, Sensorineural
Not yet recruiting
Evaluating the Feasibility and Effects of PULS
Anti Social Behavior
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.
Martin Hautzinger, Prof. contact
Michael Schönenberg, PhD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEE Training and GAZE Training in people with Psychopathy and Violent Aggressive Behavior, run by University Hospital Tuebingen 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 3 inclusion and 5 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 26 Dec 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Schönenberg, PhD (004970712978355, michael.schoenenberg@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Animated morph task (time frame: change from pre-treatment to post-treatment after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382808, which also lists 2 linked publications.
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 26 Dec 2017.