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Completed

NCT Number: NCT03732300

Attempted Suicide Short Intervention Program: a Randomized Controlled Trial

"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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Psychiatry, University Zurich

Zurich, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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,

Treatment and study plan

ASSIP

Other

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

Other names: Attempted Suicide Short Intervention Program

Primary outcomes

  1. suicide/attempted suicide

    Time frame: 12 months

    number of patients with attempted suicide or suicide

Secondary outcomes

  1. Number of toal suicide attempts

    Time frame: 3,6,12 months

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

  2. Hospitalization rates

    Time frame: 12 months

    Hospitalization rates and days and approximated treatment costs after one year

  3. EEG-vigilance

    Time frame: baseline

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

  4. ECG Heart Rate Variability

    Time frame: baseline

    Electrophysiological heart rate variability (Total Power) associated with suicidality

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Evaluation of ASSIP - Attempted Suicide Short Intervention Program: a Randomized Controlled Trial

Acronym: EASI

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 6, 2018
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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