Attempted Suicide Short Intervention Program: a Randomized Controlled Trial

Suicide, Attempted Clinical Trial

— EASI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732300
• Other study ID #: EASI
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: November 1, 2023

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Suicidality
• Suicide
• Suicide, Attempted

Intervention

Other:
• ASSIP
Three PSychotherapy Sessions plus after 3/6/9/12 months individualized letters

Locations

Country	Name	City	State
Switzerland	Department for Psychiatry, University Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	suicide/attempted suicide	number of patients with attempted suicide or suicide	12 months
Secondary	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
Secondary	Hospitalization rates	Hospitalization rates and days and approximated treatment costs after one year	12 months
Secondary	EEG-vigilance	Electrophysiological wakefulness regulation as assessed via "VIGALL" algorithm in responders and non-responders	baseline
Secondary	ECG Heart Rate Variability	Electrophysiological heart rate variability (Total Power) associated with suicidality	baseline