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

Primary Purpose

Suicide, Suicidal Ideation, Suicide, Attempted

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Suicidal Crisis Intervention (SCI)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Psychiatrisch Centrum Sint Amandus (incl. Mobiel Crisis Team)Recruiting
  • Medisch Centrum St. JozefRecruiting
  • Mobiel Crisis Team zorggroep MultiversumRecruiting
  • Openbaar Psychiatrisch Zorgcentrum GeelRecruiting
  • UZ GentRecruiting
  • Psychiatrisch Ziekenhuis Heilige Familie KortrijkRecruiting
  • Psychiatrisch Centrum AriadneRecruiting
  • Openbaar Psychiatrisch Zorgcentrum RekemRecruiting
  • Algemeen Ziekenhuis GlorieuxRecruiting
  • Psychiatrisch Ziekenhuis Sint Lucia (incl. Mobiel Team Acute Zorgen)Recruiting
  • Bethanië GGZ (incl. mobiel crisis team SARA Het Veer)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

Participants in the control group received their treatment as usual.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 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 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 (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.
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.

Full Information

First Posted
November 8, 2022
Last Updated
October 19, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05638204
Brief Title
Effectiveness of the Suicidal Crisis Intervention (SCI)
Acronym
RCT SCI
Official Title
A Randomized Controlled Study on the Effectiveness of the Suicidal Crisis Intervention (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation, Suicide, Attempted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial using permuted block randomization with variable block sizes.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants in the intervention group received the Suicidal Crisis Intervention( SCI) in addition to their treatment as usual.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the control group received their treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Suicidal Crisis Intervention (SCI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in suicidality: Beck Scale for Suicide Ideation (BSI; Beck & Steer, 1991)
Description
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.
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]
Secondary Outcome Measure Information:
Title
Change in suicidal behaviour
Description
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)
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]
Title
Change in hopelessness: The Beck Hopelessness Scale (BHS; Beck et al., 1974)
Description
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).
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]
Title
Change in defeat: Defeat Scale (DS; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version
Description
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).
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]
Title
Change in entrapment: Entrapment Scale (ES; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version
Description
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).
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]
Title
Change in isolation: Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012; Hill et al., 2015) - short version
Description
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.
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]
Title
Change in (prepared to follow) follow-up care [own questionnaire]
Description
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.
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]
Title
Treatment satisfaction [own questionnaire]
Description
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.
Time Frame
Post-test [42 days after randomization]
Other Pre-specified Outcome Measures:
Title
Treatment evaluation by close one [own questionnaire]
Description
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.
Time Frame
Post-test [42 days after randomization]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva De Jaegere, Msc
Phone
+32 (0)9 332.07.75
Email
eva.dejaegere@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Stas, Msc
Phone
+32 (0)9 332.07.75
Email
pauline.stas@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Portzky, Phd
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatrisch Centrum Sint Amandus (incl. Mobiel Crisis Team)
City
Beernem
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte De Ly
Facility Name
Medisch Centrum St. Jozef
City
Bilzen
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Brocatus
Facility Name
Mobiel Crisis Team zorggroep Multiversum
City
Boechout
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Van Camp
Facility Name
Openbaar Psychiatrisch Zorgcentrum Geel
City
Geel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riet Willems
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Portzky, PhD
Email
Gwendolyn.Portzky@uzgent.be
Facility Name
Psychiatrisch Ziekenhuis Heilige Familie Kortrijk
City
Kortrijk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Quequin
Facility Name
Psychiatrisch Centrum Ariadne
City
Lede
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fien Haijen
Facility Name
Openbaar Psychiatrisch Zorgcentrum Rekem
City
Rekem
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrien Kuypers
Facility Name
Algemeen Ziekenhuis Glorieux
City
Ronse
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lieselot Desplentere
Facility Name
Psychiatrisch Ziekenhuis Sint Lucia (incl. Mobiel Team Acute Zorgen)
City
Sint-Niklaas
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid Van Raemdonck
Facility Name
Bethanië GGZ (incl. mobiel crisis team SARA Het Veer)
City
Zoersel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filip De Donder

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9229027
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.
Results Reference
background
PubMed Identifier
12777346
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.
Results Reference
background
PubMed Identifier
21130823
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.
Results Reference
background
Citation
Michel, K., & Gysin-Maillart, A. (2015). ASSIP - Attempted Suicide Short Intervention Program: A manual for clinicians. Hogrefe Publishing.
Results Reference
background

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Effectiveness of the Suicidal Crisis Intervention (SCI)

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