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 3

Recruiting

• Conditions: Suicide, Attempted; Feasibility; Process Factors; Suicidal Ideation; Cost-effectiveness

• Registration Number: NCT06322199
• Lead Sponsor: University of Bern

Brief Summary

The present study consists of 3 projects in total. It aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the feasibility and cost-effectiveness of ASSIP flex.

The overall aim of Project 3 is to evaluate the feasibility and cost-effectiveness of ASSIP flex over a 12-month follow-up period in terms of suicide reattempts and suicide correlates in a cohort who is attending ASSIP flex after a suicide attempt.

Detailed Description

Purpose and aims:

In project 3, the feasibility and cost-effectiveness of ASSIP flex setting over a 12-month follow-up period will be investigated. To investigate that, the present study examines the newly implemented ASSIP flex service developed and implemented at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).

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 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 3 evaluates the feasibility and cost-effectiveness of ASSIP flex.

Study design of Project 3:

The present study examines longitudinally and observationally the newly implemented ASSIP flex at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland) and four additional recruitment centers. Patients after a suicide attempt who are immobile and/or not able to participate in the regular ASSIP due to other reasons (e.g., shame or fear of stigmatization) are asked to participate in the ASSIP flex project. Moreover, the ASSIP flex will be implemented and investigated in four additional recruitment centers in Switzerland: 1) Sanatorium Kilchberg in Zurich; 2) Psychiatric Hospital, University of Zurich (PUKZH); 3) Centre Hospitalier Universitaire Vaudois (CHUV); 4) Center Neuchâtelois de Psychiatrie (CNP).

All ASSIP flex patients who have agreed to participate in Project 3 (ASSIP flex) are asked to complete a baseline assessment (filling out questionnaires) before the first ASSIP flex session. This baseline assessment is conducted in the patient's environment (i.e., where the ASSIP flex sessions are carried out).

After the baseline assessment, the participants receive ASSIP flex in their personal environment, and after each ASSIP Flex session, process measurements (therapeutic alliance) are completed. Moreover, repeated measurements are conducted after four-six weeks and 12 months follow-up to assess long-term effects.

In project 3 of this study, no randomization took place, and all participants in this group received ASSIP flex.

To investigate the feasibility and effects of ASSIP flex, therapists will also be asked to complete some questionnaires. After the last flex session of each case, they are asked to fill out a brief questionnaire to rate their experiences with this ASSIP flex case. Finally, therapists are asked one year and two years after their ASSIP training to fill out a short questionnaire about their experiences with the ASSIP flex.

Study Timeline

• Study Start: 2022-09-23
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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 Flex

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Suicidal ideation (Follow-up, t1)	After the three ASSIP flex sessions are completed, up to 4-6 weeks.	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.
Suicidal ideation and suicidal behavior (Baseline, t0)	One week before the first ASSIP flex session.	The Suicidal Ideation and Behavior Scale (SSEV) is a German 9-item self-report instrument. Items 1-7 assess the frequency of suicidal ideation, suicidal intention, suicidal impulses, and suicide plan (0 = never to 5 = many times every day). A total value is calculated using items 1-7, where a value of 0-30 can result. Additionally, suicide attempts during the past four weeks and the occurrence of lifetime suicide attempts are assessed with a dichotomous response format (yes/ no) and it is asked about the frequency of lifetime suicide attempts. Higher scores indicate a more severe level of suicidal ideation, which is generally associated with a worse outcome.
Suicidal ideation and suicidal behavior (Follow-up, t1)	After the three ASSIP flex sessions are completed, up to 4-6 weeks.	The Suicidal Ideation and Behavior Scale (SSEV) is a German 9-item self-report instrument. Items 1-7 assess the frequency of suicidal ideation, suicidal intention, suicidal impulses, and suicide plan (0 = never to 5 = many times every day). A total value is calculated using items 1-7, where a value of 0-30 can result. Additionally, suicide attempts during the past four weeks and the occurrence of lifetime suicide attempts are assessed with a dichotomous response format (yes/ no) and it is asked about the frequency of lifetime suicide attempts. Higher scores indicate a more severe level of suicidal ideation, which is generally associated with a worse outcome.
Suicidal ideation (Baseline, t0)	One week before the first ASSIP flex session.	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.
Suicidal ideation and suicidal behavior (Follow-up, t2)	12 months after the baseline assessment.	The Suicidal Ideation and Behavior Scale (SSEV) is a German 9-item self-report instrument. Items 1-7 assess the frequency of suicidal ideation, suicidal intention, suicidal impulses, and suicide plan (0 = never to 5 = many times every day). A total value is calculated using items 1-7, where a value of 0-30 can result. Additionally, suicide attempts during the past four weeks and the occurrence of lifetime suicide attempts are assessed with a dichotomous response format (yes/ no) and it is asked about the frequency of lifetime suicide attempts. Higher scores indicate a more severe level of suicidal ideation, which is generally associated with a worse outcome.
Suicidal ideation (Follow-up, t2)	12 months after the baseline assessment.	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.

Secondary Outcome Measures

Name	Time	Method
Treatment costs of treatments 1	t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) up to 12 months after t0	Number of inpatient, daypatient and outpatient treatments will be assessed by DEMO.

Trial Locations

Locations (4)

Center Neuchâtelois de Psychiatrie; 🇨🇭 Neuchâtel, Switzerland

Centre Hospitalier universitaire vaudois (CHUV); 🇨🇭 Lausanne, Switzerland

Sanatorium Kilchberg; 🇨🇭 Zürich, Switzerland

Psychiatric Hospital, University of Zurich (PUKZH); 🇨🇭 Zürich, Switzerland