Effectiveness of the Suicidal Crisis Intervention (SCI) (RCT SCI)

November 6, 2023 updated by: University Hospital, Ghent

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

390

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Beernem, Belgium
        • Recruiting
        • Psychiatrisch Centrum Sint Amandus (incl. Mobiel Crisis Team)
        • Contact:
          • Charlotte De Ly
      • Bilzen, Belgium
        • Recruiting
        • Medisch Centrum St. Jozef
        • Contact:
          • Sabine Brocatus
      • Boechout, Belgium
        • Recruiting
        • Mobiel Crisis Team zorggroep Multiversum
        • Contact:
          • Lynn Van Camp
      • Geel, Belgium
        • Recruiting
        • Openbaar Psychiatrisch Zorgcentrum Geel
        • Contact:
          • Riet Willems
      • Gent, Belgium, 9000
      • Kortrijk, Belgium
        • Recruiting
        • Psychiatrisch Ziekenhuis Heilige Familie Kortrijk
        • Contact:
          • Julie Quequin
      • Kortrijk, Belgium
        • Recruiting
        • AZ Groeninge (incl. Mobiel Crisis Team Kortrijk)
        • Contact:
          • Jannes Van Damme
      • Lede, Belgium
        • Recruiting
        • Psychiatrisch Centrum Ariadne
        • Contact:
          • Fien Haijen
      • Rekem, Belgium
        • Recruiting
        • Openbaar Psychiatrisch Zorgcentrum Rekem
        • Contact:
          • Katrien Kuypers
      • Ronse, Belgium
        • Recruiting
        • Algemeen Ziekenhuis Glorieux
        • Contact:
          • Lieselot Desplentere
      • Sint-Niklaas, Belgium
        • Recruiting
        • Psychiatrisch Ziekenhuis Sint Lucia (incl. Mobiel Team Acute Zorgen)
        • Contact:
          • Astrid Van Raemdonck
      • Zoersel, Belgium
        • Recruiting
        • Bethanië GGZ (incl. mobiel crisis team SARA Het Veer)
        • Contact:
          • Filip De Donder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants in the intervention group received the Suicidal Crisis Intervention( SCI) in addition to their treatment as usual.
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.
No Intervention: Control Group
Participants in the control group received their treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
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]
Treatment satisfaction [own questionnaire]
Time Frame: Post-test [42 days after randomization]
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]

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment evaluation by close one [own questionnaire]
Time Frame: Post-test [42 days after randomization]
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]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Gwendolyn Portzky, PhD, University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 6, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2022-0376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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