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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05638204
Collaborator
(none)
390
1
2
23
17

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Suicidal Crisis Intervention (SCI)
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trial using permuted block randomization with variable block sizes.Randomized controlled trial using permuted block randomization with variable block sizes.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Study on the Effectiveness of the Suicidal Crisis Intervention (SCI)
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in suicidality: Beck Scale for Suicide Ideation (BSI; Beck & Steer, 1991) [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.

Secondary Outcome Measures

  1. Change in suicidal behaviour [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)

  2. Change in hopelessness: The Beck Hopelessness Scale (BHS; Beck et al., 1974) [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).

  3. Change in defeat: Defeat Scale (DS; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version [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).

  4. Change in entrapment: Entrapment Scale (ES; Gilbert & Allen, 1998; Griffiths et al., 2015) - short version [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).

  5. Change in isolation: Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012; Hill et al., 2015) - short version [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.

  6. Change in (prepared to follow) follow-up care [own 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]]

    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.

  7. Treatment satisfaction [own questionnaire] [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.

Other Outcome Measures

  1. Treatment evaluation by close one [own questionnaire] [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Gent Gent Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

  • Principal Investigator: Gwendolyn Portzky, Phd, University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT05638204
Other Study ID Numbers:
  • OP-6322
First Posted:
Dec 6, 2022
Last Update Posted:
Dec 27, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 27, 2022