Clinical trial NCT05638204: Effectiveness of the Suicidal Crisis Intervention (SCI)
Official title: A Randomized Controlled Study on the Effectiveness of the Suicidal Crisis Intervention (SCI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicidal Ideation
Suicide, Attempted
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial using permuted block randomization with variable block sizes.
Primary purpose: TREATMENT

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.

Detailed description: Research has extensively shown that a previous suicide attempt or a history of suicide attempts are important predictors of suicide death. It is therefore important to provide people with appropriate care after a suicide attempt to limit this risk.

Although this risk factor (previous attempts) is known, the number of interventions developed for this risk group is limited.

Based on these findings, a short-term treatment trajectory was developed for people after a suicide attempt or a suicidal crisis in Flanders, called the Suicidal Crisis Intervention (SCI). This was inspired by the ASSIP treatment trajectory and the safety plan was also given a significant place within the treatment. In addition, the importance of relatives and social support is emphasized by involving relatives in this treatment. Throughout this treatment, further (treatment) goals are drawn up, in order to generate hope for improvement and to facilitate continuity of care. More information about the concrete content of SCI will follow later in this protocol. A pilot study is currently being conducted to assess the feasibility of this treatment, as well as the experience of patients, relatives and care providers. Based on this, the SCI will be further updated for this effectiveness study.

There are currently no specific evidence-based short-term treatment methods in Flanders for people after a suicidal crisis or suicide attempt. The primary research question is therefore: 'Is the Suicidal Crisis Intervention (SCI) in Flanders an effective short-term treatment method for people after a suicidal crisis or suicide attempt?'.

The main objective of this project is to be able to offer a new, specific short-term treatment method that has been scientifically proven to reduce suicidality. In addition, we want to investigate the influence of SCI on other important aspects of suicidality (secondary goal) such as hopelessness, defeat, entrapment, and interpersonal needs.

Eligibility criteria: Inclusion Criteria Patient:

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

Exclusion Criteria Patient:

* Limited comprehension, cognitive impairment
* Psychotic disorder
* Unsuitable for individual therapy
* Receiving other forms of care is not an exclusion criterion.

Inclusion Criteria Close one:

* close one of the patient
* ≥ 18 years
* Dutch- speaking

Primary outcomes:
measure: Change in suicidality: Beck Scale for Suicide Ideation (BSI; Beck & Steer, 1991)
timeFrame: 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:
measure: Change in suicidal behaviour
timeFrame: 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]
measure: Change in hopelessness: The Beck Hopelessness Scale (BHS; Beck et al., 1974)
timeFrame: 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]
measure: Change in defeat: Defeat Scale (DS; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version
timeFrame: 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]
measure: Change in entrapment: Entrapment Scale (ES; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version
timeFrame: 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]
measure: Change in isolation: Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012; Hill et al., 2015) - short version
timeFrame: 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]
measure: Change in (prepared to follow) follow-up care [own questionnaire]
timeFrame: 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]
measure: Treatment satisfaction [own questionnaire]
timeFrame: Post-test [42 days after randomization]
Other outcomes:
measure: Treatment evaluation by close one [own questionnaire]
timeFrame: Post-test [42 days after randomization]
Locations:
city: Beernem
country: Belgium
facility: Psychiatrisch Centrum Sint Amandus (incl. Mobiel Crisis Team)
city: Bilzen
country: Belgium
facility: Medisch Centrum St. Jozef
city: Boechout
country: Belgium
facility: Mobiel Crisis Team zorggroep Multiversum
city: Geel
country: Belgium
facility: Openbaar Psychiatrisch Zorgcentrum Geel
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge (incl. Mobiel Crisis Team Kortrijk)
city: Kortrijk
country: Belgium
facility: Psychiatrisch Ziekenhuis Heilige Familie Kortrijk
city: Lede
country: Belgium
facility: Psychiatrisch Centrum Ariadne
city: Rekem
country: Belgium
facility: Openbaar Psychiatrisch Zorgcentrum Rekem
city: Ronse
country: Belgium
facility: Algemeen Ziekenhuis Glorieux
city: Sint-Niklaas
country: Belgium
facility: Psychiatrisch Ziekenhuis Sint Lucia (incl. Mobiel Team Acute Zorgen)
city: Zoersel
country: Belgium
facility: Bethanië GGZ (incl. mobiel crisis team SARA Het Veer)
Study officials:
affiliation: University Ghent
name: Gwendolyn Portzky, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Michel, K., & Gysin-Maillart, A. (2015). ASSIP - Attempted Suicide Short Intervention Program: A manual for clinicians. Hogrefe Publishing.