Attempted Suicide Short Intervention Program: a Randomized Controlled Trial (EASI)
Primary Purpose
Suicidality, Suicide, Attempted
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
ASSIP
Sponsored by
About this trial
This is an interventional treatment trial for Suicidality
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,
Sites / Locations
- Department for Psychiatry, University Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ASSIP + TAU goup
TAU
Arm Description
ASSIP psychotherapy intervention + treatment as usual (TAU)
Treatment as usual
Outcomes
Primary Outcome Measures
suicide/attempted suicide
number of patients with attempted suicide or suicide
Secondary Outcome Measures
Number of toal suicide attempts
Number of suicide attempts after 3/6 months/ one year (not a binary measure, each new attempt counts)
Hospitalization rates
Hospitalization rates and days and approximated treatment costs after one year
EEG-vigilance
Electrophysiological wakefulness regulation as assessed via "VIGALL" algorithm in responders and non-responders
ECG Heart Rate Variability
Electrophysiological heart rate variability (Total Power) associated with suicidality
Full Information
NCT ID
NCT03732300
First Posted
November 1, 2018
Last Updated
September 16, 2022
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT03732300
Brief Title
Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
Acronym
EASI
Official Title
Evaluation of ASSIP - Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidality, Suicide, Attempted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocenter, open-label, randomized parallel two study arms (ASSIP vs control)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASSIP + TAU goup
Arm Type
Experimental
Arm Description
ASSIP psychotherapy intervention + treatment as usual (TAU)
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Other
Intervention Name(s)
ASSIP
Other Intervention Name(s)
Attempted Suicide Short Intervention Program
Intervention Description
Three PSychotherapy Sessions plus after 3/6/9/12 months individualized letters
Primary Outcome Measure Information:
Title
suicide/attempted suicide
Description
number of patients with attempted suicide or suicide
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of toal suicide attempts
Description
Number of suicide attempts after 3/6 months/ one year (not a binary measure, each new attempt counts)
Time Frame
3,6,12 months
Title
Hospitalization rates
Description
Hospitalization rates and days and approximated treatment costs after one year
Time Frame
12 months
Title
EEG-vigilance
Description
Electrophysiological wakefulness regulation as assessed via "VIGALL" algorithm in responders and non-responders
Time Frame
baseline
Title
ECG Heart Rate Variability
Description
Electrophysiological heart rate variability (Total Power) associated with suicidality
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Olbrich
Organizational Affiliation
Department for Psychiatry, Psychotherapy and Psychosomatics, University Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for Psychiatry, University Zurich
City
Zürich
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26930055
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.
Results Reference
background
PubMed Identifier
33884617
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.
Results Reference
derived
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Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
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