NCT05638204

Brief Summary

The main objective of this project is to be able to offer a new, specific evidence-based short-term treatment method, the Suicidal Crisis Intervention (SCI), to reduce suicidality. In addition, this study aims to investigate the influence of SCI on other important aspects of suicidality (secondary goal) such as hopelessness, defeat, entrapment, and interpersonal needs.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jul 2023Sep 2026

First Submitted

Initial submission to the registry

November 8, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

July 11, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

November 8, 2022

Last Update Submit

November 14, 2025

Conditions

SuicideSuicidal IdeationSuicide, Attempted

Outcome Measures

Primary Outcomes (1)

  • Change in suicidality: Beck Scale for Suicide Ideation (BSI; Beck & Steer, 1991)

    The BSI is a 21-item self-report questionnaire. Each item is rated on a scale from 0 to 2, resulting in a total score ranging from 0 to 38.

    Change in baseline to post-test [42 days after randomization], to follow-up 1 [132 days after randomization] and to follow-up 2 [222days after randomization]

Secondary Outcomes (7)

  • Change in suicidal behaviour

    Change in baseline to post-test [42 days after randomization], to follow-up 1 [132 days after randomization] and to follow-up 2 [222days after randomization]

  • Change in hopelessness: The Beck Hopelessness Scale (BHS; Beck et al., 1974)

    Change in baseline to post-test [42 days after randomization], to follow-up 1 [132 days after randomization] and to follow-up 2 [222days after randomization]

  • Change in defeat: Defeat Scale (DS; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version

    Change in baseline to post-test [42 days after randomization], to follow-up 1 [132 days after randomization] and to follow-up 2 [222days after randomization]

  • Change in entrapment: Entrapment Scale (ES; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version

    Change in baseline to post-test [42 days after randomization], to follow-up 1 [132 days after randomization] and to follow-up 2 [222days after randomization]

  • Change in isolation: Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012; Hill et al., 2015) - short version

    Change in baseline to post-test [42 days after randomization], to follow-up 1 [132 days after randomization] and to follow-up 2 [222days after randomization]

  • +2 more secondary outcomes

Other Outcomes (1)

  • Treatment evaluation by close one [own questionnaire]

    Post-test [42 days after randomization]

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group received the Suicidal Crisis Intervention( SCI) in addition to their treatment as usual.

Behavioral: Suicidal Crisis Intervention (SCI)

Control Group

NO INTERVENTION

Participants in the control group received their treatment as usual.

Interventions

Suicidal Crisis Intervention (SCI)BEHAVIORAL

This study's experimental condition consisted of the Suicidal Crisis Intervention (SCI), developed by the Flemish Centre of Expertise of Suicide prevention. The SCI aims to provide tools for dealing with future suicidal crises for people after a suicidal crisis or suicide attempt. The intervention attempts to provide insight into the suicidal crisis by giving suicidality meaning within the life history. It aims to increase motivation for specialized care and therefore facilitate continuity of care. In addition, the method also wants to involve the close relative(s) of the suicidal person in the treatment. The SCI offers care providers a clear structure and handles to do this within a short period of time (4 sessions). Within the SCI are a number of crucial elements: the therapeutic relationship, involving loved ones, person-centred care, the Integrated Explanatory Model for Suicidal Behavior (Van Heeringen, 2007), the safety plan (Stanley \& Brown, 2012) and continuity of care.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • After a suicide attempt or suicidal crisis
  • ≥ 18 years
  • Availability of a smartphone, tablet and/or computer with internet access,
  • Dutch-speaking.

You may not qualify if:

  • Limited comprehension, cognitive impairment
  • Psychotic disorder
  • Unsuitable for individual therapy
  • close one of the patient
  • ≥ 18 years
  • Dutch- speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Psychiatrisch Centrum Sint Amandus (incl. Mobiel Crisis Team)

Beernem, Belgium

RECRUITING

Medisch Centrum St. Jozef

Bilzen, Belgium

RECRUITING

Mobiel Crisis Team zorggroep Multiversum

Boechout, Belgium

RECRUITING

Openbaar Psychiatrisch Zorgcentrum Geel

Geel, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

AZ Groeninge (incl. Mobiel Crisis Team Kortrijk)

Kortrijk, Belgium

RECRUITING

Psychiatrisch Ziekenhuis Heilige Familie Kortrijk

Kortrijk, Belgium

RECRUITING

Psychiatrisch Centrum Ariadne

Lede, Belgium

RECRUITING

Openbaar Psychiatrisch Zorgcentrum Rekem

Rekem, Belgium

RECRUITING

Algemeen Ziekenhuis Glorieux

Ronse, Belgium

RECRUITING

Psychiatrisch Ziekenhuis Sint Lucia (incl. Mobiel Team Acute Zorgen)

Sint-Niklaas, Belgium

RECRUITING

Bethanië GGZ (incl. mobiel crisis team SARA Het Veer)

Zoersel, Belgium

RECRUITING

Related Publications (4)

  • Harris EC, Barraclough B. Suicide as an outcome for mental disorders. A meta-analysis. Br J Psychiatry. 1997 Mar;170:205-28. doi: 10.1192/bjp.170.3.205.

    PMID: 9229027BACKGROUND

  • Hawton K, Zahl D, Weatherall R. Suicide following deliberate self-harm: long-term follow-up of patients who presented to a general hospital. Br J Psychiatry. 2003 Jun;182:537-42. doi: 10.1192/bjp.182.6.537.

    PMID: 12777346BACKGROUND

  • Nordentoft M. Crucial elements in suicide prevention strategies. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jun 1;35(4):848-53. doi: 10.1016/j.pnpbp.2010.11.038. Epub 2010 Dec 2.

    PMID: 21130823BACKGROUND

  • Michel, K., & Gysin-Maillart, A. (2015). ASSIP - Attempted Suicide Short Intervention Program: A manual for clinicians. Hogrefe Publishing.

    BACKGROUND

MeSH Terms

Conditions

SuicideSuicidal IdeationSuicide, Attempted

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Gwendolyn Portzky, Phd

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva De Jaegere, Msc

CONTACT

+32 (0)9 332.07.75eva.dejaegere@ugent.be

Pauline Stas, Msc

CONTACT

+32 (0)9 332.07.75pauline.stas@ugent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial using permuted block randomization with variable block sizes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

December 6, 2022

Study Start

July 11, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(12)