Clinical trial NCT03732300: Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
Official title: Evaluation of ASSIP - Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidality
Suicide, Attempted
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocenter, open-label, randomized parallel two study arms (ASSIP vs control)
Primary purpose: TREATMENT

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).

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,

Primary outcomes:
measure: suicide/attempted suicide
timeFrame: 12 months
Secondary outcomes:
measure: Number of toal suicide attempts
timeFrame: 3,6,12 months
measure: Hospitalization rates
timeFrame: 12 months
measure: EEG-vigilance
timeFrame: baseline
measure: ECG Heart Rate Variability
timeFrame: baseline
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Department for Psychiatry, University Zurich
Study officials:
affiliation: Department for Psychiatry, Psychotherapy and Psychosomatics, University Zurich
name: Sebastian Olbrich
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.