NCT06322199

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

Study Start

First participant enrolled

September 23, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4.3 years

First QC Date

March 6, 2024

Last Update Submit

January 22, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Suicidal ideation (Baseline, t0)

    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)

    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)

    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)

    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)

    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)

    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 Outcomes (1)

  • 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

Other Outcomes (8)

  • Sociodemographic data

    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

    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

    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

  • +5 more other outcomes

Interventions

ASSIP is a specific therapy for patients after a suicide attempt. The brief therapy ASSIP consists of 3-4 sessions of approximately 50 min. each. ASSIP flex delivers ASSIP in the patient's personal environment as an outreach home treatment. The structure of the ASSIP is the same as in the regular ASSIP, but the program is delivered in the patient's environment. Session 1: A narrative interview is conducted, in which the patient is asked to tell her 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Informed consent as documented by signature
  • Age ≥ 18 years
  • At least one previous suicide attempt
  • Willingness to attend the ASSIP Flex

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Hospitalier universitaire vaudois (CHUV)

Lausanne, Switzerland

Location

Center Neuchâtelois de Psychiatrie

Neuchâtel, Switzerland

Location

Psychiatric Hospital, University of Zurich (PUKZH)

Zurich, Switzerland

Location

Sanatorium Kilchberg

Zurich, Switzerland

Location

Related Publications (20)

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

    BACKGROUND
  • 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.

    PMID: 27523496BACKGROUND
  • 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.

    PMID: 19028399BACKGROUND
  • 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.

    PMID: 21198330BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 21123401BACKGROUND
  • 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.

    PMID: 9881538BACKGROUND
  • Hautzinger, M., et al., Beck-depressions-inventar (BDI). Bearbeitung der deutschen Ausgabe. Testhandbuch. Bern: Huber, 1994.

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

    BACKGROUND
  • 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.

    PMID: 18504506BACKGROUND
  • 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.

    PMID: 14528410BACKGROUND
  • Gysin-Maillart, Michel, Conner, Westrin and Ehnvall (in progress).

    BACKGROUND
  • 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.

    PMID: 20013760BACKGROUND
  • 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.

    PMID: 7431205BACKGROUND
  • Teismann T, et al., Skala Suizidales Erleben und Verhalten (SSEV). Diagnostica. 2021; 67(3): 115-125.

    BACKGROUND
  • 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.

    PMID: 31303020BACKGROUND
  • 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.

    PMID: 3170753BACKGROUND
  • 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.

    PMID: 30898177BACKGROUND
  • 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.

    PMID: 12501964BACKGROUND

MeSH Terms

Conditions

Suicide, AttemptedSuicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Anja C. Gysin-Maillart, PD

    Univerisity of Bern, University Hospital of Psychiatry, Translational Research Center

    PRINCIPAL INVESTIGATOR
  • Adriana O. Frei, MSc

    University of Bern, University Hospital of Psychiatry, Translational Research Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 20, 2024

Study Start

September 23, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations