NCT06263712

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 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress79%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

February 8, 2024

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

  • 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.

  • 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 Outcomes (7)

  • Movement analyses

    The assessment takes place at all 3 sessions of ASSIP or STAR, up to 1 month.

  • Selective Attention and Interference 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).

  • General Sense of Self-Efficacy

    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).

  • Locus of 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).

  • Psychological Pain

    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).

  • +2 more secondary outcomes

Other Outcomes (17)

  • Mental abilities like attention, working memory and visuomotor speed as well as mental flexibility

    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).

  • Sociodemographic data

    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).

  • Diagnostic and Statistical Manual 5 (DSM-V) and International Classification of Diseases 10 (ICD-10) psychiatric disorders

    The assessment takes place 1 day to 1 week after informed consent (t0).

  • +14 more other outcomes

Study Arms (2)

ASSIP Group

EXPERIMENTAL

Patients in the ASSIP Group will receive 3-4 sessions of the Attempted Suicide Short Intervention Program (ASSIP) which is a specific therapy for patients with a suicide attempt in their personal history. Each ASSIP session takes approximately 50 minutes.

Behavioral: Attempted Suicide Short Intervention Program (ASSIP)

STAR Group

ACTIVE COMPARATOR

Patients in the STAR group will receive the standard of care plus resource interview (STAR) which will be a risk assessment interview, and a non-specific resource focused intervention over three face-to-face sessions. In this resource focused intervention, the sessions are focused on activation of existing resources and the patients' social environment is discussed.

Behavioral: Standard of care plus resource interview group (STAR)

Interventions

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.

ASSIP Group

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.

STAR Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Psychiatry and Psychotherapy, University of Bern

Bern, 3008, Switzerland

RECRUITING

Related Publications (29)

  • 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
  • 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
  • Schiepek, G., Ressourcenorientierung und Ressourcendiagnostik in der Psychotherapie. 2003.

    BACKGROUND
  • Gysin-Maillart, A., ASSIP - Kurztherapie nach Suizidversuch. Attempted Sucide Short Intervention Program. 2. Aufl. ed. 2021, Bern: Hogrefe.

    BACKGROUND
  • Smith JL, Mattick RP, Jamadar SD, Iredale JM. Deficits in behavioural inhibition in substance abuse and addiction: a meta-analysis. Drug Alcohol Depend. 2014 Dec 1;145:1-33. doi: 10.1016/j.drugalcdep.2014.08.009. Epub 2014 Aug 24.

    PMID: 25195081BACKGROUND
  • Nock MK, Hwang I, Sampson NA, Kessler RC. Mental disorders, comorbidity and suicidal behavior: results from the National Comorbidity Survey Replication. Mol Psychiatry. 2010 Aug;15(8):868-76. doi: 10.1038/mp.2009.29. Epub 2009 Mar 31.

    PMID: 19337207BACKGROUND
  • Rath D, Hallensleben N, Glaesmer H, Spangenberg L, Strauss M, Kersting A, Teismann T, Forkmann T. [Implicit Associations with Death: First Validation of the German Version of the Suicide Implicit Association Test (Suicide IAT)]. Psychother Psychosom Med Psychol. 2018 Mar;68(3-4):109-117. doi: 10.1055/s-0043-105070. Epub 2017 Jun 29. German.

    PMID: 28718868BACKGROUND
  • Ramseyer F, Tschacher W. Nonverbal synchrony in psychotherapy: coordinated body movement reflects relationship quality and outcome. J Consult Clin Psychol. 2011 Jun;79(3):284-95. doi: 10.1037/a0023419.

    PMID: 21639608BACKGROUND
  • MacLeod CM, MacDonald PA. Interdimensional interference in the Stroop effect: uncovering the cognitive and neural anatomy of attention. Trends Cogn Sci. 2000 Oct 1;4(10):383-391. doi: 10.1016/s1364-6613(00)01530-8.

    PMID: 11025281BACKGROUND
  • Reitan, R.M. and D. Wolfson, Category Test and Trail Making Test as measures of frontal lobe functions. The Clinical Neuropsychologist, 1995. 9(1): p. 50-56.

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

    BACKGROUND
  • Kovaleva, A., et al., Eine Kurzskala zur Messung von Kontrollüberzeugung: Die Skala Internale-Externale-Kontrollüberzeugung-4 (IE-4). 2012.

    BACKGROUND
  • 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
  • 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
  • Mee S, Bunney BG, Bunney WE, Hetrick W, Potkin SG, Reist C. Assessment of psychological pain in major depressive episodes. J Psychiatr Res. 2011 Nov;45(11):1504-10. doi: 10.1016/j.jpsychires.2011.06.011. Epub 2011 Aug 9.

    PMID: 21831397BACKGROUND
  • Hautzinger, M., et al., Beck-depressions-inventar (BDI). Bearbeitung der deutschen Ausgabe. Testhandbuch. Bern: Huber, 1994.

    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
  • 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
  • Willutzki, U., et al., Direkte Veränderungsmessung in der Psychotherapie. Zeitschrift für Klinische Psychologie und Psychotherapie, 2013.

    BACKGROUND
  • 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
  • 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
  • Klonsky, E.D. and A.M. May, The three-step theory (3ST): A new theory of suicide rooted in the

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

    BACKGROUND
  • Lutz W, Böhnke JR. Der

    BACKGROUND

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Anja C. Gysin-Maillart, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja C. Gysin-Maillart, PhD

CONTACT

Kristina Adorjan, Prof. Dr. med.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

March 25, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations