SuicideNCT04307394
Development of a Video-based Intervention for Suicide Prevention
A study testing LifePlans in people with Suicide and Psychiatric Hospitalization, run by Butler Hospital at 1 site in United States.
Trial summary
The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Psychiatric Hospitalization
- What is being tested?
- LifePlans
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current psychiatric hospitalization for suicidal thoughts and behaviors
- 18 years or older
- ability to speak and read English
- plan to continue outpatient treatment
- access to means for viewing videos (computer, tablet, smartphone)
Who cannot join
- current psychotic symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Adjunctive Video-Based Suicide Prevention Intervention Immediately Following Psychiatric Hospitalization: Open Trial
The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. Patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.
- Conditions
- Suicide, Psychiatric Hospitalization
- Being tested
- LifePlans
- Keywords
- video intervention, treatment development, open trial
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifePlansBehavioural
LifePlans is a video-based intervention, in which patients watch episodes starting during a psychiatric hospitalization and continuing through 1 month post-discharge.
| Study group | Role | What they receive |
|---|---|---|
| LifePlans | Experimental | LifePlans is a video series using real patients telling their stories of overcoming suicidal thoughts and behaviors to help others who are struggling with these issues. Receives: Behavioral: LifePlans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire (CSQ)
The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.
Measured: 1 month
Secondary outcomes (1)
Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale is an interviewer-rated measure of suicidal thoughts and behaviors. The total score (sum of items) will be used and ranges from 2 to 25 with higher scores indicating higher suicidal thoughts and behaviors.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start29 Jul 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Brandon Gaudiano, PhD, Principal investigator, Butler HospitalLisa Uebelacker, Ph.D., Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307394
- Sponsor's protocol ID
- 1910-001
- Other IDs
- R34MH119414
- Status last verified
- Feb 2023
- First submitted
- 11 Mar 2020
- Last updated
- 24 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upload to NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Adjunctive Video-Based Suicide Prevention Intervention Immediately Following Psychiatric Hospitalization: Open Trial
- ClinicalTrials.gov ID
- NCT04307394
- Acronym / sponsor ID
- 1910-001
- Conditions
- Suicide, Psychiatric Hospitalization
- Keywords
- video intervention, treatment development, open trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Posted 24 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans. LifePlans will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. Patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LifePlans | Experimental | Behavioral: LifePlansLifePlans is a video series using real patients telling their stories of overcoming suicidal thoughts and behaviors to help others who are struggling with these issues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- current psychiatric hospitalization for suicidal thoughts and behaviors
- 18 years or older
- ability to speak and read English
- plan to continue outpatient treatment
- access to means for viewing videos (computer, tablet, smartphone)
Key exclusion criteria (1 listed)
- current psychotic symptoms
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 |
|---|---|---|
| LifePlansLifePlans is a video-based intervention, in which patients watch episodes starting during a psychiatric hospitalization and continuing through 1 month post-discharge. | Behavioural | LifePlans |
Primary outcome
Client Satisfaction Questionnaire (CSQ)
Time frame: 1 month
The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.
1 secondary outcome
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upload to NIMH Data Archive
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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.
Brandon Gaudiano, PhD principal investigator
Butler Hospital
Lisa Uebelacker, Ph.D. principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifePlans in people with Suicide and Psychiatric Hospitalization, run by Butler Hospital at 1 site in United States.
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 5 inclusion and 1 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 24 Mar 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Client Satisfaction Questionnaire (CSQ) (time frame: 1 month). 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 24 Mar 2023.