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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05119946
Other study ID # FHREB 2015-141
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date June 2020

Study information

Verified date November 2021
Source Fraser Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This initial study is a pilot feasibility study with a primary objective of assessing the feasibility of a larger study by evaluating the procedures and methodology, as well as collecting pilot data. The eventual research goal is to demonstrate whether a suicide prevention video in addition to standard care for suicidality is an effective strategy to reduce suicidal behaviours in individuals with a history of such. The suicide prevention video is developed as an educational tool to inform participants of the various consequences of suicide as well as giving a message of hope. It is hoped that such an approach will help to reduce future suicidal behaviours in those who have a history of such. If so, then this could be made as a part of the standard of care in treating patients with suicidality.


Description:

This pilot study will assess the study procedures and methodology to determine the feasibility of a larger study that will be done to asses for any difference in suicidal behaviours when the suicide prevention video is used in addition to standard of care. As such, the primary objectives will include: - Testing of recruitment, retention, consent, and assignment procedures - Validating the inclusion/exclusion criteria - Determining the acceptability and safety of the proposed intervention - Evaluating implementation procedures and methodology for the intervention - Evaluating the appropriateness of timing and frequency of data collection points - Evaluating the appropriateness and feasibility of the assessment tools - Obtaining parameters for sample size estimation for the larger study - Assessing the effectiveness of the video medium, content in the video and length of the video


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Age 19 years or older - Admitted to the Royal Columbian Hospital under psychiatric services - Individuals will have had suicidal behaviours as part of their presentation leading to hospitalization - Individuals must be at the level 2 observation privileges or higher - Individuals must be capable of giving consent to participate in the study - Individuals must speak and read English fluently Individuals admitted to the hospital as voluntary and involuntary (certified) patients Exclusion Criteria: - Individuals with hearing or visual deficits that impairs hearing or viewing the SPV - Individuals who are under the influence of drugs, such as intoxication or active withdrawal - Individuals with established diagnoses of cognitive impairment affecting their ability to give consent, understand what is expected of them in the study or follow directions - Patients that require a substitute decision makers to provide consent - Individuals whose behaviors an/or cognition are actively affected by ongoing psychosis, including hallucinations, delusions, and disorganized behaviors - Individuals whose treating team assess them as likely to have a negative response to the SPV, for example paranoia around electronic devices - Patient's who's attending physiatrist is one of the study team members - Patients who are currently under the direct care of any of the investigators Patients that had acute suicidality in the last 24 hours

Study Design


Intervention

Behavioral:
Suicide prevention video
The video has been developed by the research team as an educational tool to teach patients about suicide, the consequences of such and imparting a message of hope.
Other:
Standard suicide treatment
The standard suicide treatment will be determine by the attending physician and can include medications and/or psychotherapy

Locations

Country Name City State
Canada Royal Columbian and Eagle Ridge Hospitals New Westminster British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Fraser Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary An assessment of suicidal behaviours following the use of a video intervention To assess the change in suicidality of patients admitted for such using the Modified Scale for Suicidal Ideation after being given an educational video explaining common misinformation about suicide. 12 months
Secondary Mean change from baseline in the expression of suicidal ideation on the Modified Scale for Suicidal Ideation at 48 hours, 3 months and 6 months To measure the change in suicidal behaviours after viewing the video using the "The Modified Scale for Suicidal Ideation". The scale is used to assess the presence or absence of suicide ideation and the degree of severity of suicidal ideas. The benefit of this scale is that it was developed so that paraprofessionals could administer the scale, yet demonstrated excellent internal consistency and interrater reliability, correlated highly with clinician's ratings of suicidal ideation and risk, and discriminated between suicide attempters and nonattempters prior to hospitalization. The scale would be administered at baseline, after watching the video and at 3 and 6 months after watching the video. Each question is scored for a total score that is interpreted as degree of suicidal ideation. Total score range is 0 to 54. Higher scores indicate more severe suicidal ideations. Changes in the total scores will be analyzed. 12 months
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