Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 2

Self Efficacy 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 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263712
• Other study ID #: 2021-02504 (Project 2)
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: University of Bern
• Contact: Anja C. Gysin-Maillart, PhD
• Phone: +41 (0) 31 632 88 11
• Email: anja.gysin-maillart[@]unibe.ch
• Is FDA regulated: No
• Study type: Interventional

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 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland). At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2. Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1.

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. After the cross-sectional study in project 1 determining the (neuro-) psychological patterns between suicide ideators (SUID) and suicide attempters, in project 2, the aim is to learn more about the (neuro-) psychological patterns and how they are modulated by a suicide-specific brief intervention ASSIP that was proven to be effective. In addition to the (neuro-) psychological assessment, longitudinal process factors are examined by comparing an ASSIP intervention group to a group of standard care plus resource interview (STAR). The STAR intervention refers to the usual and customary practices within the field, including suicide risk assessment, a non-specific resource focused intervention and if necessary, further outpatient or inpatient treatment. 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 for 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 suicide 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. Project 1 aims is to identify the (neuro-) psychological patterns of suicidal attempters by comparing between 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 aims to 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 2: A longitudinal analysis over 12 months will only be conducted for the SUAT group. SUAT who participated in project 1 will be asked whether they also wish to participate in project 2. If they agree, they will be randomly assigned to either the intervention group ASSIP or STAR group to understand the influence of the brief ASSIP on (neuro-) psychological correlates in suicide attempters. The brief therapy ASSIP and STAR will take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland). Participants in project 2 will be assessed at 4 weeks, and 12 months after the first assessment which was conducted within project 1 and participants will be assessed on several process factors after each ASSIP or STAR session.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Project 2:

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

• Informed consent as documented by signature
• Age = 18 years
• At least one previous suicide attempt
• Willingness to attend the ASSIP brief therapy
• Owns a smartphone Exclusion Criteria for Project 2: 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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Attempted Suicide Short Intervention Program (ASSIP)
The Attempted Suicide Short Intervention Program (ASSIP) is a specific therapy for patients with a suicide attempt in their biography. The brief therapy ASSIP consists of three to four sessions of approximately 50 minutes each. Session 1: A narrative interview is conducted, in which the patient is asked to tell her*his personal story which led to the suicidal crisis. The narrative is video-recorded. Session 2: Using video-playback of the recorded narrative, patient and therapist explore further details of the suicidal process. Session 3: A case conceptualization focusing on the patient's vulnerability and the trigger of the suicidal crisis is formulated in writing. A list of safety strategies for the prevention of future suicidal behavior is developed jointly with the patient. Regular letters are sent to patients over a period of 2 years.
• Standard of care plus resource interview group (STAR)
The standard of care plus resource interview group (STAR) will be offered a clinical interview, a risk assessment, and a non-specific resource focused intervention over three face-to-face sessions. In this resource focused intervention, the patient is asked to name her*his resources, describe them, and give examples.

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 (29)

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* Note: There are 29 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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
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 (t0).
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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
Other	Therapeutic Alliance	The Working Alliance Inventory - short revised (WAI-SR) in German is an empirically validated and economic instrument to assess the therapeutic alliance.	The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.
Other	Therapeutic change	The Bochum Change Questionnaire 2000 (BVB-2000) is a direct self-report assessment for therapeutic change.	The assessment takes place after the third session of ASSIP or STAR (week 3).
Other	Therapeutic outcomes	The Questionnaire for the evaluation of psychotherapy processes (FEP-2) assesses four dimensions of therapeutic outcomes (Well-Being, General symptoms, Incongruence and Interpersonal problems).	The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.
Other	Adherence and Competence	Adherence and Competence Scales, element 1-5 (ACS). The ACS scales were developed using the ASSIP criteria.	The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.
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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
Other	Ecological Momentary Assesment	Real-time measurement of patients' risk factors using a phone app M-path. A 14-items questionnaire which is filled out 5 times a day.	Always three days before and three days after each ASSIP/STAR therapy session. Starts approximately 1 week after the informed consent and finishes approximately 4 weeks after the 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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
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 (t0).
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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
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 (t0).
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 after the completion of the 3/4 ASSIP or STAR therapy sessions (t1), i.e. approximately 4 weeks after the baseline assessment.
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 12 months after the baseline assessment (t2).
Secondary	Movement analyses	To assess nonverbal synchrony between patient and therapist, all ASSIP and STAR sessions are recorded by video cameras. The video recordings of the ASSIP sessions are subjected to Motion Energy Analysis (MEA), an objective, automatized assessment of participant's movement dynamics. MEA uses an image-differencing algorithm common to the context of computer vision, and well suited for the quantification of movement dynamics from two-dimensional recordings.The MEA program provides four continuous time-series representing the amount of movement in the head and gesture regions of both the patient and the ASSIP therapist. Based on these time-series of objective movement-quantification, a measure of nonverbal synchrony is carried out by a specific cross-correlation function.	The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.
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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
Secondary	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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
Secondary	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 (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
Secondary	Psychological Pain	The Mee-Bunney Psychological Pain Assessment Scale (MBPPAS) is a 10-item self-report scale 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.	The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
Secondary	Suicidal ideation and behavior	The Self-Injurious Thoughts and Behaviors Interview (SITBI) is a structured interview that assesses the presence, frequency, and characteristics of a wide range of self-injurious thoughts and behaviors, including suicidal ideation, suicide plans, suicide gestures, suicide attempts, and nonsuicidal self-injury. We will draw on selected questions from this interview and apply them in the form of a questionnaire.	The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).
Secondary	Suicidal ideation	The Beck Scale for Suicide Ideation (BSS) is a self-report questionnaire with 21 items. The BSS measures the ideation (suicidal thoughts, plans and suicidal feeling) of suicide.	The assessment takes place 1 day to 1 week after informed consent (t0); after the completion of the 3/4 ASSIP or STAR sessions, i.e. approximately 4 weeks after the baseline assessment (t1); 12 months after the baseline assessment (t2).