Attempted Suicide Short Intervention Program: a Randomized Controlled Trial

NCT ID: NCT03732300

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2023-11-01

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).

Conditions

Suicidality; Suicide, Attempted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ASSIP + TAU goup

ASSIP psychotherapy intervention + treatment as usual (TAU)

Group Type: EXPERIMENTAL

ASSIP

Intervention Type: OTHER

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

TAU

Treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ASSIP

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

Intervention Type: OTHER

Other Intervention Names

Attempted Suicide Short Intervention Program

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Sebastian Olbrich

Deputy Head of Center for Social Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian Olbrich

Role: PRINCIPAL_INVESTIGATOR

Department for Psychiatry, Psychotherapy and Psychosomatics, University Zurich

Locations

Department for Psychiatry, University Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 26930055 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33884617 (View on PubMed)

Other Identifiers

EASI

Identifier Type: -

Identifier Source: org_study_id