SuicidalityEASINCT03732300
Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
A study testing ASSIP in people with Suicidality and Suicide, Attempted, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicidality, Suicide, Attempted
- What is being tested?
- ASSIP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2018to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of ASSIP - Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
"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.
Read the 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
- Being tested
- ASSIP
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSIPOther
Also called Attempted Suicide Short Intervention Program
Three PSychotherapy Sessions plus after 3/6/9/12 months individualized letters
| Study group | Role | What they receive |
|---|---|---|
| ASSIP + TAU goup | Experimental | ASSIP psychotherapy intervention + treatment as usual (TAU) Receives: Other: ASSIP |
| TAU | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
suicide/attempted suicide
number of patients with attempted suicide or suicide
Measured: 12 months
Secondary outcomes (4)
Number of toal suicide attempts
Number of suicide attempts after 3/6 months/ one year (not a binary measure, each new attempt counts)
Measured: 3,6,12 months
Hospitalization rates
Hospitalization rates and days and approximated treatment costs after one year
Measured: 12 months
EEG-vigilance
Electrophysiological wakefulness regulation as assessed via "VIGALL" algorithm in responders and non-responders
Measured: baseline
ECG Heart Rate Variability
Electrophysiological heart rate variability (Total Power) associated with suicidality
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Dec 2018
- Primary completion28 Feb 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SuicidalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocenter, open-label, randomized parallel two study arms (ASSIP vs control)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Olbrich, University of Zurich
- Investigators
- Sebastian Olbrich, Principal investigator, Department for Psychiatry, Psychotherapy and Psychosomatics, University Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732300
- Sponsor's protocol ID
- EASI
- Acronym
- EASI
- Status last verified
- May 2024
- First submitted
- 1 Nov 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26930055Witt 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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ASSIP - Attempted Suicide Short Intervention Program: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03732300
- Acronym / sponsor ID
- EASI / EASI
- Conditions
- Suicidality, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Monocenter, open-label, randomized parallel two study arms (ASSIP vs control)
| Arm | Type | Receives |
|---|---|---|
| ASSIP + TAU goup | Experimental | Other: ASSIPASSIP psychotherapy intervention + treatment as usual (TAU) |
| TAU | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASSIPAlso: Attempted Suicide Short Intervention ProgramThree PSychotherapy Sessions plus after 3/6/9/12 months individualized letters | Other | ASSIP + TAU goup |
Primary outcome
suicide/attempted suicide
Time frame: 12 months
number of patients with attempted suicide or suicide
4 secondary outcomes
Number of toal suicide attempts
Time frame: 3,6,12 months
Hospitalization rates
Time frame: 12 months
EEG-vigilance
Time frame: baseline
ECG Heart Rate Variability
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 26930055Gysin-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.
- Derived from this study: PubMed 33884617Witt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Olbrich principal investigator
Department for Psychiatry, Psychotherapy and Psychosomatics, University Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASSIP in people with Suicidality and Suicide, Attempted, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
suicide/attempted suicide (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03732300, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.