NCT03382808

Brief 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. This study aims to investigate whether and under which circumstances the proposed perceptual insensitivity can be addressed with a brief implicit training approach.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

December 12, 2017

Last Update Submit

December 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    pre-treatment, after 8 weeks (post-treatment)

  • Eye-Tracking

    pre-treatment, after 8 weeks (post-treatment)

  • Ambivalence Task

    pre-treatment, after 8 weeks (post-treatment)

  • Emotional search paradigm

    pre-treatment, after 8 weeks (post-treatment)

  • Affective prosody

    pre-treatment, after 8 weeks (post-treatment)

  • +1 more secondary outcomes

Study Arms (2)

SEE Training

EXPERIMENTAL

The training sequence comprises four weekly sessions using a modified dote-probe paradigm (fearful vs. neutral expression).

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).

Behavioral: GAZE Training

Interventions

SEE TrainingBEHAVIORAL

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.

SEE Training
GAZE TrainingBEHAVIORAL

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.

GAZE Training

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed ASPD diagnosis
  • PCL-Score available
  • arrested for committing violent crimes

You may not qualify if:

  • Insufficient knowledge of the German language
  • Diagnosed with schizophrenia
  • Substance abuse
  • Neurological disease (e.g. epilepsy)
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tübingen

Tübingen, Baden Würrtemberg, 72074, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23809680BACKGROUND
  • 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.

MeSH Terms

Conditions

Antisocial Personality DisorderAggression

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Michael Schönenberg, PhD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Hautzinger, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 26, 2017

Study Start

April 1, 2017

Primary Completion

March 1, 2019

Study Completion

December 31, 2019

Last Updated

December 26, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations