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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04585802
Other study ID # 2019-01410
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 27, 2020
Est. completion date December 2024

Study information

Verified date May 2024
Source University of Bern
Contact Anja C. Gysin-Maillart, PD
Phone 031 632 88 11
Email anja.gysin-maillart@unibe.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A new approach to investigate suicidal processes belongs to the broader neurocognitive picture and are so-called implicit associations. In dual process models of information processing a second functioning mode, the automatic processing mode, complements the conscious processing. Suicidal persons tend to have a stronger implicit association with "death" than non-suicidal persons. In this study, implicit associations between different unconscious cognitive constructs are compared among suicidal and non-suicidal patients. Therefore, an adapted version of the computer-based reaction time task (IAT-S) will be used. Four different versions of IATs are tested in this study. In the first version the implicit association between "self / others" and "death / life" is assessed (1). The second and third version measures the emotional evaluation of "death" (2) and "life" (3). In addition, in the fourth version the implicit association between death / life and internal / external locus of control is assessed (4). The implicit associations of these four IAT-S versions are compared between three groups: patients with suicidal behavior, patients with suicidal ideation, and a clinical group without previous suicide attempts and without suicidal ideation. The following hypotheses are made: in all four versions of the IAT-S, patients with previous suicidal behavior will have stronger implicit associations: between "self" and "death" as well as "death" and "internal locus of control" compared to all other groups. With a more "positive" evaluation of "death" and a more "negative" evaluation of "life" than all other participants.


Description:

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Study Design


Locations

Country Name City State
Switzerland University Hospital of Psychiatry and Psychotherapy, University of Bern Bern

Sponsors (2)

Lead Sponsor Collaborator
University of Bern University Hospital of Psychiatry, Department Neuropsychopharmacology and Brain Imaging

Country where clinical trial is conducted

Switzerland, 

References & Publications (14)

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Outcome

Type Measure Description Time frame Safety issue
Primary Implicit Association Test (IAT) The German version of the Suicide Implicit Association Test (Rath et al., 2018) is administered using a computer paradigm and is designed to measure implicit associations with death using D-values. D is an individual effect size assessment that reflects the comparative difficulty of performing the two response conditions of the IAT, with a value of 0 indicating that the tasks had equivalent performance (Greenwald et al., 2003). D has a theoretical minimum of -2 and maximum of +2 when blocks of the same size are compared (Nosek & Sriram, 2007). The more positive the D-values, the stronger the association between the "self" and "death" than between the "self" and "life". One assessment at baseline after study information and informed consent was given
Secondary Suicide Behaviors Questionnaire - Revised The Suicide Behaviors Questionnaire measures suicidal behavior in the past and consists of four items. Item scores range from 3 to 18 with higher scores indicating more suicidal behavior (Osman et al., 2001). One assessment at baseline after study information and informed consent was given
Secondary Beck Scale for Suicide Ideation (BSS) The Beck-Scale for Suicide Ideation measures suicidal thinking and consists of 21 items. Item scores range from 0 to 42 with higher scores indicating more suicidal ideation (Beck & Steer, 1993; Kliem & Brähler, 2016). One assessment at baseline after study information and informed consent was given
Secondary Beck Depression Inventory (BDI-II) The Beck Depression Inventory measures the severity of depression and consists of 21 items. Item scores range from 0 to 63 with higher scores indicating a higher intensity of depression (Beck, Steer & Brown, 1996). One assessment at baseline after study information and informed consent was given
Secondary Mee-Bunney Psychological Pain Assessment Scale (MBPPAS) The Mee-Bunney Psychological Pain Assessment Scale measures psychological pain and consists of 10 items. Item scores range from 10 to 50 with higher scores indicating more psychological pain (Mee et al., 2011). One assessment at baseline after study information and informed consent was given
Secondary Positive Mental Health Scale (PMH-scale) Positive Mental Health Scale measures positive mental health ans consists of 9 items. Item scores range from 9 to 36 with higher scores indicating more positive mental health (Lukat, Margraf, Lutz, van der Veld & Becker, 2016). One assessment at baseline after study information and informed consent was given
Secondary Internal External Locus of Control-4 (IE-4) The IE-4 is a Scale for the Assessment of Locus of Control and consists of two subscales with two items each. For each subscale, the mean value of the two items is calculated, which can range from 1 to 5 with higher scores indication more internal/external locus of control (Kemper, Beierlein, Kovaleva, & Rammstedt, 2012). One assessment at baseline after study information and informed consent was given
Secondary Mini-International Neuropsychiatric Interview (M.I.N.I.) The Mini-International Neuropsychiatric Interview is a brief structured diagnostic interview to assess the most common psychiatric disorders (Sheehan et al., 1998). One assessment at baseline after study information and informed consent was given
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