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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Martin Hautzinger, Prof.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SEE Training
The training sequence comprises four weekly sessions using a modified dote-probe paradigm (fearful vs. neutral expression).
Behavioral: SEE Training
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).
Behavioral: GAZE Training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Tuebingen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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