Neuropsychological Patterns of Suicide Ideators and Suicide Attempters

Suicidal Ideation Clinical Trial

— NePsyAssip HT  

Official title:

Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy ASSIP on Neuropsychological Correlates and Psychological Process Factors (NePsyASSIP HT) - Project 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248268
• Other study ID #: 2021-02504 (Project 1)
• Status: Recruiting
• 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
• 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:

Purpose and aims:

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 aim of this project is to distinguish the (neuro-) psychological patterns of suicide ideators from suicide attempters by investigating four experimental groups. For this purpose, neuropsychological functioning, as well as psychological process factors, are analyzed. Patients with at least one prior suicide attempt are compared to patients with suicidal ideation, to a clinical control group, as well as to healthy controls. For this project, patients who are being treated at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland) at the time of the project will be requested. Afterwards, participants with a suicide attempt in their history will also be asked to participate in the longitudinal part of the study, which is Project 2.

Background:

In Switzerland, approximately three people die by suicide every day, and suicide attempts exceed this number by far. As a previous suicide attempt is one of the strongest predictors of a completed suicide, it is of utmost importance to identify the people at risk. However, research has shown that traditional risk factors (e.g., depression, psychiatric disorder, etc.) reliably predict suicidal ideation but poorly predict suicidal behavior. Furthermore, while effective suicide-specific interventions exist, up to 50% of the suicide attempters reject the recommended treatment, and around 60% discontinue treatment after one session. Hence, a different approach is required. In this study, three projects will be conducted. In Project 1, (neuro-) psychological patterns of suicide attempters will be identified by comparing the following four different groups:

1. patients with a prior suicide attempt (SUAT),

2. patients with no prior suicide attempt but suicidal ideation (SUID),

3. a general patient group (CLIN), and

4. a healthy control group (HLTH).

Project 2 will investigate how these patterns are modulated by the efficacious brief therapy ASSIP. In Project 3, the feasibility, effects and cost-effectiveness of the ASSIP Home Treatment will be investigated.

Study design of Project 1:

Project 1 of this study is a quantitative cross-sectional and observational 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 suicidal behavior or ideation (CLIN), and the healthy group (HLTH). The cohorts to be examined (SUAT & SUID) will be compared to two control groups (CLIN & HLTH). Study participants in Project 1 will participate in a one-time (neuro-) psychological assessment. To account for the heterogeneity in suicide attempters, suicide ideators, generally clinical patients and healthy controls, the samples will be balanced for age, gender and treatment setting by group matching.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects fulfilling the following inclusion criteria are eligible for the study:

• Informed consent as documented by signature

• Age = 18 years

Additional inclusion criteria for the SUAT group:

• At least one previous suicide attempt

• Willingness to attend the ASSIP brief therapy

For the SUID, CLIN, and HLTH groups, no further inclusion criteria are formulated.

Exclusion Criteria:

The presence of any one of the following exclusion criteria will lead to exclusion of the subject:

• Serious cognitive impairment

• Any psychotic disorder

• Any current medication, which substantially impairs the attention span, reaction, rate or any other relevant cognitive functions

• Inability to follow the procedures of the study (e.g., insufficient mastery of the German language, previous enrolment into the current study)

Additional exclusion criterion for the SUID, CLIN and HLTH group:

• Previous suicidal behavior

Additional exclusion criteria for the CLIN and HLTH groups:

• Suicidal ideation

Related Conditions & MeSH terms

• Attention
• Locus of Control
• Self Efficacy
• Suicidal Ideation
• Suicide
• Suicide, Attempted

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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Bostwick JM, Pabbati C, Geske JR, McKean AJ. Suicide Attempt as a Risk Factor for Completed Suicide: Even More Lethal Than We Knew. Am J Psychiatry. 2016 Nov 1;173(11):1094-1100. doi: 10.1176/appi.ajp.2016.15070854. Epub 2016 Aug 13. — View Citation

Hautzinger, M., et al., Beck-depressions-inventar (BDI). Bearbeitung der deutschen Ausgabe. Testhandbuch. Bern: Huber, 1994.

Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574. — View Citation

Klonsky ED, May A. Rethinking impulsivity in suicide. Suicide Life Threat Behav. 2010 Dec;40(6):612-9. doi: 10.1521/suli.2010.40.6.612. — View Citation

Lizardi D, Stanley B. Treatment engagement: a neglected aspect in the psychiatric care of suicidal patients. Psychiatr Serv. 2010 Dec;61(12):1183-91. doi: 10.1176/ps.2010.61.12.1183. — View Citation

MacLeod CM, MacDonald PA. Interdimensional interference in the Stroop effect: uncovering the cognitive and neural anatomy of attention. Trends Cogn Sci. 2000 Oct 1;4(10):383-391. doi: 10.1016/s1364-6613(00)01530-8. — View Citation

May, A.M. and E.D. Klonsky, What distinguishes suicide attempters from suicide ideators? A meta-analysis of potential factors. Clinical Psychology: Science and Practice, 2016. 23(1): p. 5.

Mee S, Bunney BG, Bunney WE, Hetrick W, Potkin SG, Reist C. Assessment of psychological pain in major depressive episodes. J Psychiatr Res. 2011 Nov;45(11):1504-10. doi: 10.1016/j.jpsychires.2011.06.011. Epub 2011 Aug 9. — View Citation

Nock MK, Park JM, Finn CT, Deliberto TL, Dour HJ, Banaji MR. Measuring the suicidal mind: implicit cognition predicts suicidal behavior. Psychol Sci. 2010 Apr;21(4):511-7. doi: 10.1177/0956797610364762. Epub 2010 Mar 9. — View Citation

Peter, C. and A. Tuch, Suizidgedanken und Suizidversuche in der Schweizer Bevölkerung. Obsan Bulletin. Vol. 7. 2019, Nêuchatel. 2019.

Reitan, R.M. and D. Wolfson, Category Test and Trail Making Test as measures of frontal lobe functions. The Clinical Neuropsychologist, 1995. 9(1): p. 50-56.

Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472. — View Citation

Schwarzer, R. and M. Jerusalem, Skala zur allgemeinen Selbstwirksamkeitserwartung. 1999, Berlin: Freie Universität Berlin. 2013.

Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. — View Citation

Smith JL, Mattick RP, Jamadar SD, Iredale JM. Deficits in behavioural inhibition in substance abuse and addiction: a meta-analysis. Drug Alcohol Depend. 2014 Dec 1;145:1-33. doi: 10.1016/j.drugalcdep.2014.08.009. Epub 2014 Aug 24. — View Citation

Ystgaard M, Arensman E, Hawton K, Madge N, van Heeringen K, Hewitt A, de Wilde EJ, De Leo D, Fekete S. Deliberate self-harm in adolescents: comparison between those who receive help following self-harm and those who do not. J Adolesc. 2009 Aug;32(4):875-91. doi: 10.1016/j.adolescence.2008.10.010. Epub 2008 Nov 22. — View Citation

* Note: There are 17 references in all — Click here to view all references

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.