- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06322199
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 (NePsyAssip HT)
Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy ASSIP on Neuropsychological Correlates and Psychological Process Factors (NePsyASSIP HT) - Project 3
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lausanne, Switzerland
- Centre Hospitalier Universitaire Vaudois (CHUV)
-
Neuchâtel, Switzerland
- Center Neuchâtelois de Psychiatrie
-
Zurich, Switzerland
- Psychiatric Hospital, University of Zurich (PUKZH)
-
Zurich, Switzerland
- Sanatorium Kilchberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Participants with a past suicide attempt will be recruited at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland) and following recruitment centers:
- Sanatorium Kilchberg Private Clinic for Psychiatry and Psychotherapy
- Psychiatric University Hospital Zurich (PUKZH)
- Vaud University Hospital (CHUV) in Lausanne
- Department of General and Liaison Psychiatry CNP in Neuchâtel
Description
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
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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal ideation (Baseline, t0)
Time Frame: 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.
|
One week before the first ASSIP flex session.
|
|
Suicidal ideation and suicidal behavior (Baseline, t0)
Time Frame: 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.
|
One week before the first ASSIP flex session.
|
|
Suicidal ideation (Follow-up, t1)
Time Frame: 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.
|
After the three ASSIP flex sessions are completed, up to 4-6 weeks.
|
|
Suicidal ideation and suicidal behavior (Follow-up, t1)
Time Frame: 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.
|
After the three ASSIP flex sessions are completed, up to 4-6 weeks.
|
|
Suicidal ideation (Follow-up, t2)
Time Frame: 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.
|
12 months after the baseline assessment.
|
|
Suicidal ideation and suicidal behavior (Follow-up, t2)
Time Frame: 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.
|
12 months after the baseline assessment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment costs of treatments 1
Time Frame: 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.
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic data
Time Frame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
The Sociodemographic Questionnaire (DEMO) is a 65-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).
|
t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
|
Depressive symptoms
Time Frame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
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.
|
t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
|
General sense of self-efficacy
Time Frame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
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).
The individual test score is calculated as the sum of the 10-item responses.
This results in a total score of 10 to 40 points.
A higher score indicates a stronger belief in one's ability to cope with and navigate different situations.
|
t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
|
Self-Management
Time Frame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
The self-management self-test (SMST) assesses self-management skills and consists of five items.
The assessment is based on a five-point Likert scale (0-4 points).
The items are added together so that the overall scale can have a value of 0-20 (0-4 = poor self-management, 5-8 = relatively poor self-management, 9-12 = mediocre self-management, 13-16 = fairly good self-management, 17-20 = good self-management).
|
t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
|
Health Literacy
Time Frame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
The Health Literacy Questionnaire (HLS19-Q12) assesses the general health literacy of people and contains 12 items which are assessed on a four-point Likert scale (1 = very difficult, 4 = very easy).
The overall scale can have a value of 12-48.
A higher score means less difficulties in accessing, understanding, evaluating and applying information to tasks related to decision-making on health topics.
|
t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
|
Loneliness
Time Frame: t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
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).
The overall scale can have a value of 3-9.
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.
|
t0) Before the first ASSIP flex session, 1 week after informed consent procedure; t1) After the intervention, 4-6 weeks after t0; t2) 12 months after t0
|
|
Therapeutic Alliance
Time Frame: After the three ASSIP flex sessions are completed up to 4-6 weeks.
|
The Working Alliance Inventory - short revised (WAI-SR) in German is an empirical instrument for recording the therapeutic alliance.
It contains 12 items on three scales.
Each item is rated on a 5-point Likert scale (rarely = 1 to always = 5).
The individual test score is calculated by totaling the 12-item responses, resulting in a score between 12 and 60.
A higher value means a better therapeutic alliance.
|
After the three ASSIP flex sessions are completed up to 4-6 weeks.
|
|
Adherence and Competence
Time Frame: After the three ASSIP flex sessions are completed, up to 4-6 weeks.
|
Adherence and Competence Scales, elements 1-5.
The ACS scales were developed using the ASSIP criteria.
Therefore, five different elements were distinguished (narrative interview, video playback, case conceptualization, homework, letters).
Compliance with the ASSIP manuals is ensured by means of the Adherence and Competence Scale (ACS) and its corresponding coding manual.
A higher value means better adherence
|
After the three ASSIP flex sessions are completed, up to 4-6 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anja C. Gysin-Maillart, PD, Univerisity of Bern, University Hospital of Psychiatry, Translational Research Center
- Study Chair: Adriana O. Frei, MSc, University of Bern, University Hospital of Psychiatry, Translational Research Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Beck AT, Steer RA, Ranieri WF. Scale for Suicide Ideation: psychometric properties of a self-report version. J Clin Psychol. 1988 Jul;44(4):499-505. doi: 10.1002/1097-4679(198807)44:43.0.co;2-6.
- Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010 May-Jun;17(3):231-9. doi: 10.1002/cpp.658.
- Peter, C. and A. Tuch, Suizidgedanken und Suizidversuche in der Schweizer Bevölkerung. Obsan Bulletin. Vol. 7. 2019, Nêuchatel. 2019.
- 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.
- 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.
- 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.
- 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.
- Schwarzer, R. and M. Jerusalem, Skala zur allgemeinen Selbstwirksamkeitserwartung. 1999, Berlin: Freie Universität Berlin. 2013.
- Hautzinger, M., et al., Beck-depressions-inventar (BDI). Bearbeitung der deutschen Ausgabe. Testhandbuch. Bern: Huber, 1994.
- Hasler G, Klaghofer R, Buddeberg C. [The University of Rhode Island Change Assessment Scale (URICA)]. Psychother Psychosom Med Psychol. 2003 Sep-Oct;53(9-10):406-11. doi: 10.1055/s-2003-42172. German.
- Gysin-Maillart, Michel, Conner, Westrin and Ehnvall (in progress).
- Teismann T, et al., Skala Suizidales Erleben und Verhalten (SSEV). Diagnostica. 2021; 67(3): 115-125.
- Klonsky, E.D. and A.M. May, The three-step theory (3ST): A new theory of suicide rooted in the "ideation-to-action" framework. International Journal of Cognitive Therapy, 2015. 8(2): p. 114-129.
- Wehmeier PM, Fox T, Doerr JM, Schnierer N, Bender M, Nater UM. Development and Validation of a Brief Measure of Self-Management Competence: The Self-Management Self-Test (SMST). Ther Innov Regul Sci. 2019 Jul 14:2168479019849879. doi: 10.1177/2168479019849879. Online ahead of print.
- Lean M, Fornells-Ambrojo M, Milton A, Lloyd-Evans B, Harrison-Stewart B, Yesufu-Udechuku A, Kendall T, Johnson S. Self-management interventions for people with severe mental illness: systematic review and meta-analysis. Br J Psychiatry. 2019 May;214(5):260-268. doi: 10.1192/bjp.2019.54. Epub 2019 Mar 22.
- Goldney RD, Fisher LJ, Wilson DH, Cheok F. Mental health literacy of those with major depression and suicidal ideation: an impediment to help seeking. Suicide Life Threat Behav. 2002 Winter;32(4):394-403. doi: 10.1521/suli.32.4.394.22343.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-02504 (Project 3)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Feasibility
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Mental Health (NIMH)CompletedFeasibilityUnited States
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Mental Health (NIMH)Completed
-
University of UtahCompletedFeasibility StudiesUnited States
-
Kliniken Ludwigsburg-Bietigheim gGmbHUnknownFeasibility, ComplicationsGermany
-
Coxa, Hospital for Joint ReplacementTampere UniversityNot yet recruiting
-
University of Maryland, BaltimoreNational Institute on Aging (NIA); The Claude D. Pepper Older Americans Independence...Recruiting
-
Northeastern UniversityRecruiting
-
University of Southern DenmarkEuropean Research CouncilCompleted
-
Arizona State UniversityNational Institute on Drug Abuse (NIDA)RecruitingFeasibility Studies | AcceptabilityUnited States
Clinical Trials on ASSIP (Attempted Suicide Short Intervention Program) flex
-
University of ZurichCompletedSuicide, Attempted | SuicidalitySwitzerland
-
University of BernCompletedSuicidal Ideation | Suicide | Suicide AttemptSwitzerland
-
Ardakan UniversityRecruitingSuicide | Suicide IdeationIran, Islamic Republic of
-
University of RochesterNorthwestern University; State University of New York - Upstate Medical University and other collaboratorsCompleted
-
Gold Coast Hospital and Health ServiceBond UniversityNot yet recruiting
-
University of RochesterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedSuicide, Attempted | Drug Use | Alcohol; Use, ProblemUnited States
-
University of BernRecruitingSuicide, Attempted | Self Efficacy | Suicide Ideation | Locus of Control | Inhibitory Control | Process Factors | Movement SynchronySwitzerland
-
Meir Medical CenterUnknownStress, PsychologicalIsrael
-
Aydin Adnan Menderes UniversityThe Scientific and Technological Research Council of TurkeyRecruitingSuicidal Ideation | Suicide Prevention | School CounselingTurkey (Türkiye)
-
Centro Hospitalar Universitário de Santo AntónioOncology Research, Unit for Multidisciplinary Research in Biomedicine (UMIB)... and other collaboratorsActive, not recruitingEarly Breast Cancer | Cancer-related Fatigue | Triple Negative Breast Cancer (TNBC) | HER2-Positive Breast Cancer | Quality of Life (QOL)Portugal