Attempted Suicide Short Intervention Program: a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Suicide, Attempted; Suicidality
• Interventions: Other: ASSIP

• Registration Number: NCT03732300
• Lead Sponsor: University of Zurich

Brief 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.

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).

Study Timeline

• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-06
• Study Start: 2018-12-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-11-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASSIP + TAU goup	ASSIP	ASSIP psychotherapy intervention + treatment as usual (TAU)

Primary Outcome Measures

Name	Time	Method
suicide/attempted suicide	12 months	number of patients with attempted suicide or suicide

Secondary Outcome Measures

Name	Time	Method
Number of toal suicide attempts	3,6,12 months	Number of suicide attempts after 3/6 months/ one year (not a binary measure, each new attempt counts)
Hospitalization rates	12 months	Hospitalization rates and days and approximated treatment costs after one year
EEG-vigilance	baseline	Electrophysiological wakefulness regulation as assessed via "VIGALL" algorithm in responders and non-responders
ECG Heart Rate Variability	baseline	Electrophysiological heart rate variability (Total Power) associated with suicidality

Trial Locations

Locations (1)

Department for Psychiatry, University Zurich; 🇨🇭 Zürich, Switzerland