SuicideRCT SCINCT05638204
Effectiveness of the Suicidal Crisis Intervention (SCI)
A study testing Suicidal Crisis Intervention (SCI) in people with Suicide and Suicidal Ideation, run by University Hospital, Ghent at 12 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide, Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Suicidal Crisis Intervention (SCI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 12 sitesBelgium
- Study dates
- 11 Jul 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- After a suicide attempt or suicidal crisis
- ≥ 18 years
- Availability of a smartphone, tablet and/or computer with internet access,
- Dutch-speaking.
- close one of the patient
- ≥ 18 years
- Dutch- speaking
Who cannot join
- Limited comprehension, cognitive impairment
- Psychotic disorder
- Unsuitable for individual therapy
- Receiving other forms of care is not an exclusion criterion.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Belgium12 sites, 12 recruiting
- Recruiting
Psychiatrisch Centrum Sint Amandus (incl. Mobiel Crisis Team)
Beernem
Charlotte De Ly
- Recruiting
Medisch Centrum St. Jozef
Bilzen
Sabine Brocatus
- Recruiting
Mobiel Crisis Team zorggroep Multiversum
Boechout
Lynn Van Camp
- Recruiting
Openbaar Psychiatrisch Zorgcentrum Geel
Geel
Riet Willems
- Recruiting
UZ Gent
Ghent, 9000
Gwendolyn Portzky, PhD, Gwendolyn.Portzky@uzgent.be
- Recruiting
AZ Groeninge (incl. Mobiel Crisis Team Kortrijk)
Kortrijk
Jannes Van Damme
- Recruiting
Psychiatrisch Ziekenhuis Heilige Familie Kortrijk
Kortrijk
Julie Quequin
- Recruiting
Psychiatrisch Centrum Ariadne
Lede
Fien Haijen
- Recruiting
Openbaar Psychiatrisch Zorgcentrum Rekem
Rekem
Katrien Kuypers
- Recruiting
Algemeen Ziekenhuis Glorieux
Ronse
Lieselot Desplentere
- Recruiting
Psychiatrisch Ziekenhuis Sint Lucia (incl. Mobiel Team Acute Zorgen)
Sint-Niklaas
Astrid Van Raemdonck
- Recruiting
Bethanië GGZ (incl. mobiel crisis team SARA Het Veer)
Zoersel
Filip De Donder
About this study
Official title: A Randomized Controlled Study on the Effectiveness of the Suicidal Crisis Intervention (SCI)
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.
Read the 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.
- Conditions
- Suicide, Suicidal Ideation, Suicide, Attempted
- Being tested
- Suicidal Crisis Intervention (SCI)
- Medical subject headings
- Suicide, Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicidal Crisis Intervention (SCI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group received the Suicidal Crisis Intervention( SCI) in addition to their treatment as usual. Receives: Behavioral: Suicidal Crisis Intervention (SCI) |
| Control Group | No intervention | Participants in the control group received their treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: 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)
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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.
Measured: 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 (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.
Measured: 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]
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.
Measured: Post-test [42 days after randomization]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start11 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies 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
- Randomized controlled trial using permuted block randomization with variable block sizes.
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Portzky, Phd, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638204
- Sponsor's protocol ID
- ONZ-2022-0376
- Acronym
- RCT SCI
- Status last verified
- Nov 2025
- First submitted
- 8 Nov 2022
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9229027Hawton 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.
PubMed 12777346Nordentoft 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.
PubMed 21130823Michel, K., & Gysin-Maillart, A. (2015). ASSIP - Attempted Suicide Short Intervention Program: A manual for clinicians. Hogrefe Publishing.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Effectiveness of the Suicidal Crisis Intervention (SCI)
- ClinicalTrials.gov ID
- NCT05638204
- Acronym / sponsor ID
- RCT SCI / ONZ-2022-0376
- Conditions
- Suicide, Suicidal Ideation, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Dec 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial using permuted block randomization with variable block sizes.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Suicidal Crisis Intervention (SCI)Participants in the intervention group received the Suicidal Crisis Intervention( SCI) in addition to their treatment as usual. |
| Control Group | No intervention | –Participants in the control group received their treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- After a suicide attempt or suicidal crisis
- ≥ 18 years
- Availability of a smartphone, tablet and/or computer with internet access,
- Dutch-speaking.
- close one of the patient
Key exclusion criteria (4 listed)
- Limited comprehension, cognitive impairment
- Psychotic disorder
- Unsuitable for individual therapy
- Receiving other forms of care is not an exclusion criterion.
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 |
|---|---|---|
| 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. | Behavioural | Intervention Group |
Primary outcome
Change in suicidality: Beck Scale for Suicide Ideation (BSI; Beck & Steer, 1991)
Time frame: 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]
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.
7 secondary outcomes
Change in suicidal behaviour
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 (prepared to follow) follow-up care [own questionnaire]
Time frame: 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]
Treatment satisfaction [own questionnaire]
Time frame: Post-test [42 days after randomization]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 9229027Harris 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.
- Background: PubMed 12777346Hawton 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.
- Background: PubMed 21130823Nordentoft 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.
- BackgroundMichel, K., & Gysin-Maillart, A. (2015). ASSIP - Attempted Suicide Short Intervention Program: A manual for clinicians. Hogrefe Publishing.
- Individual participant dataSharing planned: No
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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.
Gwendolyn Portzky, Phd principal investigator
University Ghent
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suicidal Crisis Intervention (SCI) in people with Suicide and Suicidal Ideation, run by University Hospital, Ghent at 12 sites in Belgium.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva De Jaegere, Msc (+32 (0)9 332.07.75, eva.dejaegere@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicidality: Beck Scale for Suicide Ideation (BSI; Beck & Steer, 1991) (time frame: 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]). 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 NCT05638204, which also lists 4 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 18 Nov 2025.