Attempted Suicide Short Intervention Program: a Randomized Controlled Trial (EASI)

Evaluation of ASSIP - 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.

Study Overview

• Status: Completed
• Conditions: Suicide, Attempted; Suicidality
• Intervention / Treatment: Other: ASSIP

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland
    • Department for Psychiatry, University Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: TAU; Treatment as usual
Experimental: ASSIP + TAU goup; ASSIP psychotherapy intervention + treatment as usual (TAU)	Other: ASSIP; Three PSychotherapy Sessions plus after 3/6/9/12 months individualized letters; Other Names: Attempted Suicide Short Intervention Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
suicide/attempted suicide	number of patients with attempted suicide or suicide	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Sebastian Olbrich, Department for Psychiatry, Psychotherapy and Psychosomatics, University Zurich

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: EASI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No