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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03382808
Other study ID # SCHO 1448/3-1
Secondary ID
Status Recruiting
Phase N/A
First received December 12, 2017
Last updated December 18, 2017
Start date April 1, 2017
Est. completion date December 31, 2019

Study information

Verified date December 2017
Source University Hospital Tuebingen
Contact Michael Schönenberg, PhD
Phone 004970712978355
Email michael.schoenenberg@uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Interventional

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


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Germany University of Tübingen Tübingen Baden Würrtemberg

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Tuebingen German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schönenberg 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 pre-treatment, after 8 weeks (post-treatment)
Secondary 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 pre-treatment, after 8 weeks (post-treatment)
Secondary Ambivalence Task Change in interpretation of ambiguous emotional faces as indicated by number of hostile judgments pre-treatment, after 8 weeks (post-treatment)
Secondary 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) pre-treatment, after 8 weeks (post-treatment)
Secondary Affective prosody Change in recognition of non-verbal emotional aspects of language as assessed by number of correct classifications pre-treatment, after 8 weeks (post-treatment)
Secondary Multifaceted empathy test Assessment of cognitive and emotional empathy (change pre- to post-intervention) pre-treatment, after 8 weeks (post-treatment)
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