- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05127330
Pilot RCT of a Video-based Intervention for Suicide Prevention
March 26, 2024 updated by: Butler Hospital
The investigators will develop a brief video-based intervention for suicide prevention, called LifePlans.
LifePlans will be tested in a pilot randomized controlled trial (n = 40) 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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bailey O'Keffe
- Phone Number: 401-680-4252
- Email: BOkeeffe@butler.org
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Butler Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- current psychiatric hospitalization for suicidal thoughts and behaviors
- 18 years or older
- ability to speak and read English
- access to means for viewing videos (computer, tablet, smartphone)
Exclusion Criteria:
- current psychotic symptoms
- current cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LifePlans
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.
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LifePlans is a video-based intervention, in which patients watch episodes starting during a psychiatric hospitalization and continuing through 1 month post-discharge.
Other mental health treatment is unrestricted.
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Active Comparator: Treatment as Usual
Individuals will receive unrestricted routine care only.
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Individuals will receive unrestricted routine mental health care in the community as appropriate for their condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 1 Month
|
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.
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1 Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa Uebelacker, PhD, Butler Hospital
- Principal Investigator: Brandon Gaudiano, PhD, Butler Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
November 30, 2023
Study Registration Dates
First Submitted
November 12, 2021
First Submitted That Met QC Criteria
November 12, 2021
First Posted (Actual)
November 19, 2021
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1504431
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Upload to NIMH Data Archive
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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