Effectiveness of the Suicidal Crisis Intervention (SCI)

Suicide Clinical Trial

— RCT SCI  

Official title:

A Randomized Controlled Study on the Effectiveness of the Suicidal Crisis Intervention (SCI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638204
• Other study ID #: ONZ-2022-0376
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Ghent
• Contact: Eva De Jaegere, Msc
• Phone: +32 (0)9 332.07.75
• Email: eva.dejaegere[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: January 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• Suicidal Crisis Intervention (SCI)
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.

Locations

Country	Name	City	State
Belgium	Psychiatrisch Centrum Sint Amandus (incl. Mobiel Crisis Team)	Beernem
Belgium	Medisch Centrum St. Jozef	Bilzen
Belgium	Mobiel Crisis Team zorggroep Multiversum	Boechout
Belgium	Openbaar Psychiatrisch Zorgcentrum Geel	Geel
Belgium	UZ Gent	Gent
Belgium	AZ Groeninge (incl. Mobiel Crisis Team Kortrijk)	Kortrijk
Belgium	Psychiatrisch Ziekenhuis Heilige Familie Kortrijk	Kortrijk
Belgium	Psychiatrisch Centrum Ariadne	Lede
Belgium	Openbaar Psychiatrisch Zorgcentrum Rekem	Rekem
Belgium	Algemeen Ziekenhuis Glorieux	Ronse
Belgium	Psychiatrisch Ziekenhuis Sint Lucia (incl. Mobiel Team Acute Zorgen)	Sint-Niklaas
Belgium	Bethanië GGZ (incl. mobiel crisis team SARA Het Veer)	Zoersel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

References & 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. — View 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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment evaluation by close one [own questionnaire]	To investigate how close ones of the patients in the intervention group experienced the SCI, some evaluative questions are asked. Participants are asked to indicate how many sessions they received, how they would rate the treatment [0-10], what they thought of the number and length of sessions [too little/short, good, too many/long], rate to what degree they agreed [strongly disagree, disagree, neutral, agree, strongly agree, not applicable] with 8 statements about the treatment, and 2 open questions about the strengths, weaknesses of the treatment.	Post-test [42 days after randomization]
Primary	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	Change in suicidal behaviour	Using two questions participants will be asked whether they have experienced suicidal thoughts (lifetime and since last measure, or last year for baseline) and whether they attempted suicide (lifetime and since last measure, or last year for baseline)	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	Change in hopelessness: The Beck Hopelessness Scale (BHS; Beck et al., 1974)	A 20-item self-report questionnaire to measure hopelessness in adolescents and adults. Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 20, with higher scores indicating higher levels of hopelessness (worse outcome).	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	Change in defeat: Defeat Scale (DS; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version	A 4-item self-report questionnaire to measure defeat on a five-point Likert scale. A total score ranging from 0 to 16 is obtained, with higher scores indicating more perceptions of defeat (worse outcome).	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	Change in entrapment: Entrapment Scale (ES; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version	A 4-item self-report questionnaire to measure entrapment on a five-point Likert scale. A total score ranging from 0 to 16 is obtained, with higher scores indicating more perceptions of entrapment (worse outcome).	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	Change in isolation: Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012; Hill et al., 2015) - short version	This is a 10-item questionnaire where each item is rated on a 7-point Likert scale with 1= Not at all true for me, 4 = somewhat true for me and 7 = very true for me.	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	Change in (prepared to follow) follow-up care [own questionnaire]	To assess whether participants receive follow-up care or are prepared to receive follow-up care, 14 questions were asked. About which psychological [none, GP, psychologist, psychiatrist, other health care worker, residential care, waiting list], medical [no medication, pain killers, tranquilizers/anxiolytics, sleeping pills, antidepressants, antipsychotics, other] treatment they were currently receiving, they started/stopped/changed since the start of the study and or prepared to receive. This will not result in a total score, but instead will be used as a descriptive questionnaire.	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	Treatment satisfaction [own questionnaire]	To investigate how patients of the intervention group experienced the SCI, some evaluative questions are asked. Participants are asked to indicate how many sessions they received, how they would rate the treatment [0-10], what they thought of the number and length of sessions [too little/short, good, too many/long], rate to what degree they agreed [strongly disagree, disagree, neutral, agree, strongly agree, not applicable] with 8 statements about the treatment, and 2 open questions about the strengths, weaknesses of the treatment.	Post-test [42 days after randomization]