Suicidality, Suicide, Attempted
Conditions
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).
Interventions
OTHERASSIP
Three PSychotherapy Sessions plus after 3/6/9/12 months individualized letters
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Monocenter, open-label, randomized parallel two study arms (ASSIP vs control)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| suicide/attempted suicide | 12 months | number of patients with attempted suicide or suicide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed