Suicidal IdeationNCT05119946
A Feasibility Study of a Suicide Prevention Video
A study testing Suicide prevention video and Standard suicide treatment in people with Suicidal Ideation and Suicide Attempts, run by Fraser Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Suicidal Ideation, Suicide Attempts, Psychiatric Illness
- What is being tested?
- Suicide prevention video and Standard suicide treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Columbian and Eagle Ridge Hospitals
New Westminster, British Columbia
About this study
Official title: A Pilot Study of the Effectiveness of a Suicide Prevention Video Tool to Reduce the Incidence of Active Suicide Behavior in Individuals With Psychiatric Illness
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.
Read the detailed 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
- Conditions
- Suicidal Ideation, Suicide Attempts, Psychiatric Illness
- Being tested
- Suicide prevention video, Standard suicide treatment
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide prevention videoBehavioural
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.
Standard suicide treatmentOther
The standard suicide treatment will be determine by the attending physician and can include medications and/or psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Suicide prevention video | Experimental | In this group, in addition to receiving the standard of care for their suicidality, the participants will also view a suicide prevention video. Receives: Behavioral: Suicide prevention video; Other: Standard suicide treatment |
| Standard suicide treatment | Active comparator | In this group, participants will only receive the standard of care for their suicidality, which can include medications and/or therapy. The care will be determine by their attending physician. Receives: Other: Standard suicide treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study startJan 2017
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hem Phaterpekar, MD, Principal investigator, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119946
- Sponsor's protocol ID
- FHREB 2015-141
- Status last verified
- Nov 2021
- First submitted
- 23 Aug 2016
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effectiveness of a Suicide Prevention Video Tool to Reduce the Incidence of Active Suicide Behavior in Individuals With Psychiatric Illness
- ClinicalTrials.gov ID
- NCT05119946
- Acronym / sponsor ID
- FHREB 2015-141
- Conditions
- Suicidal Ideation, Suicide Attempts, Psychiatric Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 15 Nov 2021 (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.
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.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suicide prevention video | Experimental | Behavioral: Suicide prevention video, Other: Standard suicide treatmentIn this group, in addition to receiving the standard of care for their suicidality, the participants will also view a suicide prevention video. |
| Standard suicide treatment | Active comparator | Other: Standard suicide treatmentIn this group, participants will only receive the standard of care for their suicidality, which can include medications and/or therapy. The care will be determine by their attending physician. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Suicide prevention videoThe 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. | Behavioural | Suicide prevention video |
| Standard suicide treatmentThe standard suicide treatment will be determine by the attending physician and can include medications and/or psychotherapy | Other | Standard suicide treatment, Suicide prevention video |
Primary outcome
An assessment of suicidal behaviours following the use of a video intervention
Time frame: 12 months
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.
1 secondary outcome
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
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- 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. This study is not recruiting at the moment.
Hem Phaterpekar, MD principal investigator
Fraser Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suicide prevention video and Standard suicide treatment in people with Suicidal Ideation and Suicide Attempts, run by Fraser Health at 1 site in Canada.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An assessment of suicidal behaviours following the use of a video intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2021.