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CompletedNCT03732300EASIUpdated May 8, 2024

Attempted Suicide Short Intervention Program: a Randomized Controlled Trial

An interventional study of ASSIP in Suicidality and Suicide, Attempted, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Zurich · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

"Attempted Suicide Short Intervention Program" (ASSIP) is a brief psychotherapy intervention after suicide attempts in psychiatric patients. The study aims to analyse the efficacy in a controlled trial by comparing number of patients with suicide attempts in a control group with treatment as usual and an intervention group with treatment as usual and ASSIP intervention.

Further, the study aims at indentifying electrophysiological, sociodempgraphical or smartphone-derived parameters for prediction of further suicide attempts.

Read the detailed description

Suicide is the second leading cause of death among the 14-40 years old in Switzerland. Every year around 800'000 people all over the world die due to suicide (WHO, 2017). Preceding suicide attempts and self-harming behaviour have been found to be the main risk factor for completed suicide. The "Attempted Suicide Short Intervention Program" (ASSIP) has been designed to reduce further suicide attempts and suicide in patients after a suicide attempt. This study aims to replicate the findings of another study (Gysin-Maillart, Schwab, Soravia, Megert, \& Michel, 2016) that show the efficacy of ASSIP. Further, it is intended to identify predictors for positive treatment outcome, i.e. a reduction of further suicide attempts in patients that had already committed a suicide attempt.

Main objective:

Assessment of efficacy of ASSIP by comparison of the number of patients that committed suicide attempts in the intervention (ASSIP) and the control group.

Secondary objectives:

  • Identification of sociodemographic, clinical, electrophysiological and smartphone-based marker predicting the treatment outcome, rehospitalization rates and treatment costs Identification of predictors of treatment efficacy of ASSIP (by means of electroencephalogram parameters, electrocardiogram parameters, sensing app parameters, sociodemographic parameters and voice/video material parameters.

Identification of electrophysiological representations of suicidality (patient group, control group, healthy controls).

02

Conditions studied

  • Suicidality
  • Suicide, Attempted
03

In context

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's enrollment of 100 is close to the median of 104 across 560 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Age 18 or older
  • Attempted suicide no longer than 6 months before inclusion
  • Treatment in and outpatient clinic of the University Hospital of Psychiatry Zurich, a daycare clinic or on a ward of the University Hospital of Psychiatry Zurich
  • Able and willing to comply with all study requirements, especially being able to participate and understand psychotherapy sessions

Exclusion criteria

Exclusion Criteria:

  • Acute psychosis with delusion and/or hallucination
  • Dementia
  • Insufficient ability to communicate in German language
  • Chronic self-harming behaviour without a direct intention of suicide (Wolfersdorf \& Etzersdorfer, 2011)
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Current electroconvulsive therapy (do to interference between cognitive side effects and psychotherapeutic intervention)
  • Participation in another study with investigational drug within the 30 days preceding and during the present study,
  • Previous enrolment into the current study,
  • Enrolment of the investigator, his/her family members, employees and other dependent persons,
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    ASSIP + TAU goup

    ASSIP psychotherapy intervention + treatment as usual (TAU)

    Other: ASSIP

  • No intervention
    TAU

    Treatment as usual

Interventions

  • OtherASSIP

    Three PSychotherapy Sessions plus after 3/6/9/12 months individualized letters

    Also known as: Attempted Suicide Short Intervention Program

06

What researchers measure

Primary outcomes

  1. suicide/attempted suicide

    number of patients with attempted suicide or suicide

    Time frame: 12 months

Secondary outcomes

  1. Number of toal suicide attempts

    Number of suicide attempts after 3/6 months/ one year (not a binary measure, each new attempt counts)

    Time frame: 3,6,12 months

  2. Hospitalization rates

    Hospitalization rates and days and approximated treatment costs after one year

    Time frame: 12 months

  3. EEG-vigilance

    Electrophysiological wakefulness regulation as assessed via "VIGALL" algorithm in responders and non-responders

    Time frame: baseline

  4. ECG Heart Rate Variability

    Electrophysiological heart rate variability (Total Power) associated with suicidality

    Time frame: baseline

07

Study locations

1 site
  • Department for Psychiatry, University Zurich
    Zürich, Switzerland
08

References and documents

Publications

  • Gysin-Maillart A, Schwab S, Soravia L, Megert M, Michel K. A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP). PLoS Med. 2016 Mar 1;13(3):e1001968. doi: 10.1371/journal.pmed.1001968. eCollection 2016 Mar. PubMed 26930055 ↗
  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2. PubMed 33884617 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03732300
Lead sponsor
University of Zurich
Responsible party
Sebastian Olbrich (Deputy Head of Center for Social Psychiatry, University of Zurich) — Principal investigator
First posted
Nov 6, 2018
Start date
Dec 1, 2018
Primary completion
Feb 28, 2023
Completion
Nov 1, 2023
Last update
May 8, 2024

Study contacts

Sebastian Olbrich
principal investigator · Department for Psychiatry, Psychotherapy and Psychosomatics, University Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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