NCT03732300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

4.2 years

First QC Date

November 1, 2018

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • suicide/attempted suicide

    number of patients with attempted suicide or suicide

    12 months

Secondary Outcomes (4)

  • Number of toal suicide attempts

    3,6,12 months

  • Hospitalization rates

    12 months

  • EEG-vigilance

    baseline

  • ECG Heart Rate Variability

    baseline

Study Arms (2)

ASSIP + TAU goup

EXPERIMENTAL

ASSIP psychotherapy intervention + treatment as usual (TAU)

Other: ASSIP

TAU

NO INTERVENTION

Treatment as usual

Interventions

ASSIPOTHER

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

Also known as: Attempted Suicide Short Intervention Program
ASSIP + TAU goup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Age 18 or older
  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Psychiatry, University Zurich

Zurich, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 26930055BACKGROUND
  • 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.

MeSH Terms

Conditions

Suicidal IdeationSuicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Sebastian Olbrich

    Department for Psychiatry, Psychotherapy and Psychosomatics, University Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Monocenter, open-label, randomized parallel two study arms (ASSIP vs control)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of Center for Social Psychiatry

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 6, 2018

Study Start

December 1, 2018

Primary Completion

February 28, 2023

Study Completion

November 1, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations