Clinical trial NCT06248268: Neuropsychological Patterns of Suicide Ideators and Suicide Attempters
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inhibitory Control
Locus of Control
Self Efficacy
Suicide, Attempted
Suicidal Ideation
Attention
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This quantitative cross-sectional study with four groups will be conducted at the University Hospital of Psychiatry and Psychotherapy, Bern. 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 two control groups (CLIN \& HLTH).

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in Inhibitory Control
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
Secondary outcomes:
measure: Selective Attention and Interference Control
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
Other outcomes:
measure: Mental abilities like attention, working memory and visuomotor speed as well as mental flexibility
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Attention and Concentration Abilities
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Sociodemographic data
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Diagnostic and Statistical Manual 5 (DSM-V) and International Classification of Diseases 10 (ICD-10) psychiatric disorders
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Suicidal Ideation
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Depressive Symptoms
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Psychological Pain
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: General Sense of Self-Efficacy
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Loneliness
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Locus of Control
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Suicide-Related Coping
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Dissociative Experience
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Motivational Goals
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Motivational Incongruence
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Alcohol Use Screening
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
measure: Physiologically Experienced Emotional Distress and Arousal
timeFrame: The assessment takes place 1 day to 1 week after informed consent.
Locations:
city: Bern
country: Switzerland
facility: University Hospital of Psychiatry and Psychotherapy, University of Bern
Study officials:
affiliation: University of Bern, University Hospital of Psychiatry, Translational Research Center
name: Anja C. Gysin-Maillart, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern, University Hospital of Psychiatry, Translational Research Center
name: Lara M. Aschenbrenner, M.Sc.
role: STUDY_CHAIR
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