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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06248268
Other study ID # 2021-02504 (Project 1)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2024
Est. completion date December 2026

Study information

Verified date March 2024
Source University of Bern
Contact Anja C. Gysin-Maillart, Ph.D.
Phone +41 (0) 31 632 88 11
Email anja.gysin-maillart@unibe.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment. The overall aim of project 1 is to determine (neuro-) psychological differences between suicide attempters, suicide ideators, a clinical control group, and healthy controls. Study participants in project 1 will participate in a one-time (neuro-) psychological assessment. Project 1 of this study is an observational cross-sectional study with four groups that will be conducted at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland): Patients with at least one suicide attempt in their past (SUAT), patients with suicidal ideation (SUID), patients from the same clinical cohort, without neither suicidal behavior or ideation (CLIN) and the healthy group (HLTH). The cohorts to be examined (SUAT & SUID) will be compared to the two control groups (CLIN & HLTH). Only people who have signed the informed consent and meet the eligibility criteria can participate in this study.


Description:

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Study Design


Intervention

Other:
(Neuro-)psychological assessment
The measurement, which takes place 1 week after the informed consent, aims to determine the distinct (neuro-) psychological patterns of suicidal behavior versus suicidal ideation, in comparison to two control groups.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (17)

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Outcome

Type Measure Description Time frame Safety issue
Other Mental abilities like attention, working memory and visuomotor speed as well as mental flexibility The Trail Making Test (TMT-A/B) is a neuropsychological test that assesses visual attention and task-switching abilities. It consists of two parts (Part A and Part B) and measures the time taken to complete each part. The score is typically represented as the time (in seconds) taken to complete the task. Lower scores (faster completion times) are generally considered better outcomes, indicating more efficient visual attention, processing speed, and cognitive flexibility. Higher scores (longer completion times) may suggest difficulties in these cognitive domains and are typically associated with worse outcomes. The assessment takes place 1 day to 1 week after informed consent.
Other Attention and Concentration Abilities The D2 Test of Attention and Concentration is a neuropsychological test used to assess selective and sustained attention. It is employed to evaluate an individual's visual scanning, concentration, and information processing speed. The D2 Test involves scoring based on the number of correctly marked items minus the number of errors. The scoring method considers both the quantity and accuracy of responses. The goal is to mark as many target items as possible within a specified time limit while avoiding errors. A higher score is considered a better outcome, indicating more correct responses and effective attention and concentration. The assessment takes place 1 day to 1 week after informed consent.
Other Sociodemographic data The Sociodemographic Questionnaire (DEMO) is a 30-item questionnaire that was developed to collect sociodemographic (e.g., gender, socioeconomic status, professional status, relationship satisfaction) and health-related data (e.g., medication, inpatient and outpatient treatment). The assessment takes place 1 day to 1 week after informed consent.
Other Diagnostic and Statistical Manual 5 (DSM-V) and International Classification of Diseases 10 (ICD-10) psychiatric disorders The Mini-DIPS is a short, structured clinical interview for diagnosing mental disorders and is based on the DIPS-OA. The Mini-DIPS allows for a quick yet reliable diagnosis. It is applicable in adulthood and captures lifetime diagnoses, current and past diagnoses, based on the criteria of DSM-5 and ICD-10. The Mini-DIPS covers the mental disorders most commonly observed in clinical settings. The assessment takes place 1 day to 1 week after informed consent.
Other Suicidal Ideation The Beck Scale for Suicide Ideation (BSI) is a clinical assessment tool designed to measure the severity of suicidal ideation in individuals. It is used in clinical and research settings to assess the risk of suicide. The BSI consists of 19 items, and each item is scored on a 3-point scale (0 to 2). The total score, which ranges from 0 to 38, reflects the severity of suicidal ideation. The minimum score is 0, indicating no suicidal ideation and the maximum score is 38, indicating the highest level of suicidal ideation. Higher scores indicate a greater severity of suicidal ideation, and thus, higher scores are generally associated with a worse outcome. The assessment takes place 1 day to 1 week after informed consent.
Other Depressive Symptoms The Beck Depression Inventory (BDI-II) is a self-assessment questionnaire and contains 21 items which assess the severity of depressive symptoms. A participant's score is calculated by summing up the scores from each item. The total score ranges from 0 to 63. Values between 0 and 11 lie within the norm, between 11 and 17 moderate depressive symptoms and a total score up to 18 is assessed as a clinically relevant depressive disorder. The assessment takes place 1 day to 1 week after informed consent.
Other Psychological Pain The Mee-Bunney Psychological Pain Assessment Scale (MBPPAS) is a 10-item self-report questionnaire to assess intensity and frequency of psychological pain. Psychological pain is defined as an experience of unbearable agony which can be linked to a psychiatric disorder. Each of the 10 items is rated on a 5-point Likert scale from 1 (never) to 5 (always) or from 1 (none) to 5 (unbearable). The item scores are added up to a total score. A higher score indicates higher psychological pain. The assessment takes place 1 day to 1 week after informed consent.
Other General Sense of Self-Efficacy The General Self-Efficacy Scale (GSE) is a 10-item self-report questionnaire to assess the general sense of self-efficacy. Items are rated from 1 (do not agree) to 4 (totally agree). A higher score indicates a stronger belief in one's ability to cope with and navigate different situations. The assessment takes place 1 day to 1 week after informed consent.
Other Loneliness The Three-Item UCLA (University of California, Los Angeles) Loneliness Scale is a short questionnaire with three items from the Revised UCLA Loneliness Scale (R-UCLA). These items can be rated from 1 (hardly ever) to 3 (often). A higher score indicates a higher level of perceived loneliness. The scale is designed to measure subjective feelings of loneliness, so individuals who score higher on the UCLA Loneliness Scale report more frequent experiences of loneliness and social isolation. The assessment takes place 1 day to 1 week after informed consent.
Other Locus of Control The Internal-External Locus of Control Short Scale-4 (IE-4) is a brief measure designed to assess an individual's locus of control orientation. Locus of control refers to the extent to which individuals believe they control events in their lives. The IE-4 is typically scored by summing the responses to its four items, each rated on a Likert scale. The possible score range is determined by the specific scoring method researchers or practitioners use. The scores may range from 4 to 16, depending on the scoring system employed. Higher scores on the IE-4 may suggest a more internal locus of control, indicating a belief that one has control over their life events. Lower scores may indicate a more external locus of control, suggesting a belief that external factors or luck play a significant role in life events. The assessment takes place 1 day to 1 week after informed consent.
Other Suicide-Related Coping Coping with suicidal ideation and behavior will be assessed with the Suicide-Related Coping Scale (SRCS). The self-report scale SCRS consists of 17 items, with each rated on a five-point Likert scale from "strongly disagree" = 0 to "strongly agree" = 4. A total SRCS sum score is calculated by inverting the negatively worded items and then summing the 17 items. A higher sum score indicates better suicide-related coping. The assessment takes place 1 day to 1 week after informed consent.
Other Dissociative Experience The German Dissociation-Tension Scale - 4 (DSS-4) is a four-item brief self-report instrument to assess dissociation. It was developed based on the DSS-acute, a longer scale to measure dissociative symptoms. The four DSS-4 items assess somatic and psychological dissociation and each item is rated on a 10-point Likert scale ranging from "not present" = 0 to "very strong" = 9. Based on the DSS-4, a dissociation score per participant is calculated as the mean of the four items. The assessment takes place 1 day to 1 week after informed consent.
Other Motivational Goals The Questionnaire for the Analysis of Motivational Schemas (FAMOS) assesses the motivational goals of psychotherapy in terms of central components of motivational schemas in self-report format. The questionnaire FAMOS assesses motivational goals as approach goals on 14 scales and avoidance goals on 9 scales, with a total of 94 items. Each item is rated on a five-point Likert scale. For each scale, the scale mean of the corresponding items is calculated. In addition, three summary values can be calculated: 1) total value for approach goals; 2) total value for avoidance goals; and 3) the ratio of avoidance to approach goals. The assessment takes place 1 day to 1 week after informed consent.
Other Motivational Incongruence The Incongruence Questionnaire (INK) measures unsatisfactory realization of motivational goals, whereas the personal relevance of motivation is measured in the FAMOS. The questionnaire INK assesses the realization of approach and avoidance goals on 14 and 9 scales, respectively, with a total of 94 items. Each item to assess approach goals is assessed on a five-point Likert scale. For each scale, the mean value of the corresponding item values must be determined. In addition, it is possible to calculate three composite scales: 1) incongruence with avoidance goals; 2) incongruence with approach goals; and 3) total incongruence. The assessment takes place 1 day to 1 week after informed consent.
Other Physiologically Experienced Emotional Distress and Arousal Electrodermal activity (EDA), also known as skin conductance or galvanic skin response, is a valuable physiological marker in suicide research. EDA measures the skin's electrical conductance, reflecting sympathetic nervous system activity. Suicidal individuals often experience heightened emotional distress and arousal, challenging assessment via self-reports alone. EDA offers an objective, non-invasive means to quantify this emotional response, with distinct patterns observed in those at risk of suicide. The assessment takes place 1 day to 1 week after informed consent.
Primary Differences in Inhibitory Control The Go/No-Go task is a cognitive task to assess an individual's ability to inhibit a prepotent response. It is used to measure impulse control and response inhibition. The task requires participants to respond ("Go" response) to one type of stimulus and to withhold or inhibit their response ("No-Go" response) to another type of stimulus. The Go/No-Go task yields measures such as reaction time, accuracy, and the ability to inhibit responses. Reaction times can vary widely, and accuracy is often expressed as a percentage of correct responses. Lower reaction times and higher accuracy in withholding responses (No-Go trials) indicate better inhibitory control and cognitive performance. The assessment takes place 1 day to 1 week after informed consent.
Secondary Selective Attention and Interference Control The Stroop task is a cognitive psychology test that evaluates an individual's ability to selectively attend to information while inhibiting interference from irrelevant stimuli. The Stroop task measures the time taken to complete tasks and the accuracy of responses. The primary measures are the time taken to complete the task and the number of errors. Lower completion times and fewer errors indicate better cognitive control and attentional focus. Lower scores (faster completion times and fewer errors) are associated with better outcomes, reflecting more efficient cognitive processing and interference control. Higher scores, if used to quantify errors or time taken, are associated with a worse outcome, indicating greater interference and potentially reduced cognitive control. The assessment takes place 1 day to 1 week after informed consent.
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